Introduction Despite the CONSORT guidelines, which aim to improve the quality of studies, authors often formulate conclusions based on the dichotomous distinction of the p-value, declaring differences between ′statistically significant′ and ′non-significant′. This approach confuses the identification of the real efficacy of the studied treatment. To solve this problem, CONSORT guidelines recommend using confidence intervals, which offer a more complete view of possible effects. However, authors′ conclusions often remain based on a binary approach, confusing the absence of evidence with the evidence of absence. This error can influence clinical practice and future research, leading to the identification of ′negative′ treatments based on ′statistical insignificance′, which reflects a lack of evidence of absence, not the absence of evidence. Objectives To assess the prevalence of misinterpretation of non-statistically significant results, both in the abstract and in the article, in a sample of all randomised controlled trials (RCTs) with non-statistically significant primary outcomes published in 5 rehabilitation journals with the highest impact factor (IF) published between 2019 and 2023 and to assess whether the primary outcome result is reported according to CONSORT guidelines. Methods We will conduct a cross-sectional analysis of all Rcts with non-statistically significant primary outcomes in 5 general rehabilitation journals with the highest IF published between 2019 and 2023. We will determine the prevalence of trials in which non-significance is interpreted as absence of evidence, evidence of absence, or advice to use the intervention in clinical practice in the abstract and article conclusions, and the prevalence of trials that adhered to CONSORT guidelines for reporting the primary outcome.
{"title":"CROSS-SECTIONAL ANALYSIS: INTERPRETATION OF NON-STATISTICALLY SIGNIFICANT RESULTS IN RANDOMISED CONTROLLED CLINICAL TRIALS IN REHABILITATION","authors":"Caterina Mugnai, Luca Falsiroli Maistrello, Giacomo Fiacca, Michele Perucchini, Noemi Corbetta, Federico Amateis, Stefano Salvioli","doi":"10.1101/2024.09.16.24313294","DOIUrl":"https://doi.org/10.1101/2024.09.16.24313294","url":null,"abstract":"Introduction Despite the CONSORT guidelines, which aim to improve the quality of studies, authors often formulate conclusions based on the dichotomous distinction of the p-value, declaring differences between ′statistically significant′ and ′non-significant′. This approach confuses the identification of the real efficacy of the studied treatment. To solve this problem, CONSORT guidelines recommend using confidence intervals, which offer a more complete view of possible effects. However, authors′ conclusions often remain based on a binary approach, confusing the absence of evidence with the evidence of absence. This error can influence clinical practice and future research, leading to the identification of ′negative′ treatments based on ′statistical insignificance′, which reflects a lack of evidence of absence, not the absence of evidence. Objectives To assess the prevalence of misinterpretation of non-statistically significant results, both in the abstract and in the article, in a sample of all randomised controlled trials (RCTs) with non-statistically significant primary outcomes published in 5 rehabilitation journals with the highest impact factor (IF) published between 2019 and 2023 and to assess whether the primary outcome result is reported according to CONSORT guidelines. Methods We will conduct a cross-sectional analysis of all Rcts with non-statistically significant primary outcomes in 5 general rehabilitation journals with the highest IF published between 2019 and 2023. We will determine the prevalence of trials in which non-significance is interpreted as absence of evidence, evidence of absence, or advice to use the intervention in clinical practice in the abstract and article conclusions, and the prevalence of trials that adhered to CONSORT guidelines for reporting the primary outcome.","PeriodicalId":501453,"journal":{"name":"medRxiv - Rehabilitation Medicine and Physical Therapy","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142259603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-16DOI: 10.1101/2024.09.16.24312391
Erinn M Grigsby, Lilly W Tang, Arianna Damiani, Jonathan C Ho, Isabella Montanaro, Sirisha Nouduri, Sara Trant, Theodora Constantine, Gregory M Adams, Kevin M Franzese, Bradford Z Mahon, Julie Fiez, Donald J Crammond, Kaila L Stipancic, Jorge A Gonzalez-martinez, Elvira Pirondini
Speech and swallowing are complex motor acts that depend upon the integrity of input neural signals from motor cortical areas to control muscles of the head and neck. Lesions damaging these neural pathways result in weakness of key muscles causing dysarthria and dysphagia, leading to profound social isolation and risk of aspiration and suffocation. Here we show that Deep Brain Stimulation (DBS) of the motor thalamus improved speech and swallowing functions in two participants with dysarthria and dysphagia. First, we proved that DBS increased excitation of the face motor cortex, augmenting motor evoked potentials, and range and speed of motion of orofacial articulators in n=10 volunteers with intact neural pathways. Then, we demonstrated that this potentiation led to immediate improvement in swallowing functions in a patient with moderate dysphagia and profound dysarthria as a consequence of a traumatic brain lesion. In this subject and in another with mild dysarthria, we showed that DBS immediately ameliorated impairments of respiratory, phonatory, resonatory, and articulatory control thus resulting in a clinically significant improvement in speech intelligibility. Our data provide first-in-human evidence that DBS can be used to treat dysphagia and dysarthria in people with cerebral lesions.
{"title":"Targeted deep brain stimulation of the motor thalamus improves speech and swallowing motor functions after cerebral lesions","authors":"Erinn M Grigsby, Lilly W Tang, Arianna Damiani, Jonathan C Ho, Isabella Montanaro, Sirisha Nouduri, Sara Trant, Theodora Constantine, Gregory M Adams, Kevin M Franzese, Bradford Z Mahon, Julie Fiez, Donald J Crammond, Kaila L Stipancic, Jorge A Gonzalez-martinez, Elvira Pirondini","doi":"10.1101/2024.09.16.24312391","DOIUrl":"https://doi.org/10.1101/2024.09.16.24312391","url":null,"abstract":"Speech and swallowing are complex motor acts that depend upon the integrity of input neural signals from motor cortical areas to control muscles of the head and neck. Lesions damaging these neural pathways result in weakness of key muscles causing dysarthria and dysphagia, leading to profound social isolation and risk of aspiration and suffocation. Here we show that Deep Brain Stimulation (DBS) of the motor thalamus improved speech and swallowing functions in two participants with dysarthria and dysphagia. First, we proved that DBS increased excitation of the face motor cortex, augmenting motor evoked potentials, and range and speed of motion of orofacial articulators in n=10 volunteers with intact neural pathways. Then, we demonstrated that this potentiation led to immediate improvement in swallowing functions in a patient with moderate dysphagia and profound dysarthria as a consequence of a traumatic brain lesion. In this subject and in another with mild dysarthria, we showed that DBS immediately ameliorated impairments of respiratory, phonatory, resonatory, and articulatory control thus resulting in a clinically significant improvement in speech intelligibility. Our data provide first-in-human evidence that DBS can be used to treat dysphagia and dysarthria in people with cerebral lesions.","PeriodicalId":501453,"journal":{"name":"medRxiv - Rehabilitation Medicine and Physical Therapy","volume":"214 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142259606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-15DOI: 10.1101/2024.09.14.24313686
Jun Nakatake, Shigeaki Miyazaki, Hideki Arakawa, Etsuo Chosa
Understanding elementary feeding movements and postures is essential for improving assessment and intervention strategies in occupational therapy, particularly for individuals with eating difficulties, and for educating caregivers and students; however, current assessment tools lack precision in evaluating complex feeding movements and often rely on subjective judgments rather than objective measures. We aimed to determine elementary movements and postures corresponding to different feeding phases using principal component analysis (PCA). This cross-sectional observational study was conducted at a Local National University Hospital and included 45 healthy, right-handed adult volunteers (23 men and 22 women) aged 20–39 years (mean age, 27.3 years), with no neurological or musculoskeletal impairments. Movements during yogurt feeding using a spoon were captured with a three-dimensional inertial sensor motion capture system. Principal components (PCs) and their scores were derived from PCA of whole-body joint motion data across four feeding phases. PC scores were compared between phases using Friedman’s and post-hoc tests. The primary PC, representing whole-body movement, accounted for 50.0% of the variance; the second PC, associated with hand direction changes, accounted for 13.7%. The cumulative variance of the first six PCs was 87.4%, including individual body-part movements and fixations or combinations of these. Significant differences existed between feeding phases, particularly in the reaching and transport phases, which showed greater whole-body movement than that during the spooning and mouth phases. Hand direction changes were more prominent during the spooning phase than during the mouth phase. PCA helped determine key elementary movements and their corresponding feeding phases, which can be used to assess patients with feeding difficulties and guide occupational therapy interventions.
了解基本的进食动作和姿势对于改善职业治疗中的评估和干预策略至关重要，尤其是对于进食困难的个体，以及对护理人员和学生进行教育也是如此；然而，目前的评估工具在评估复杂的进食动作时缺乏精确性，而且往往依赖于主观判断而非客观测量。我们的目的是利用主成分分析法（PCA）确定与不同进食阶段相对应的基本动作和姿势。这项横断面观察研究在一家地方国立大学医院进行，包括 45 名健康、右撇型成年志愿者（23 名男性和 22 名女性），年龄在 20-39 岁之间（平均年龄为 27.3 岁），无神经或肌肉骨骼损伤。使用三维惯性传感器动作捕捉系统捕捉了用勺子喂酸奶时的动作。通过对四个喂食阶段的全身关节运动数据进行 PCA 分析，得出了主成分（PC）及其得分。使用弗里德曼检验和事后检验比较了不同阶段的 PC 分值。代表全身运动的主要 PC 占方差的 50.0%；与手部方向变化相关的第二个 PC 占方差的 13.7%。前六个 PC 的累积方差为 87.4%，包括单个身体部位运动和定点或这些运动的组合。不同喂食阶段之间存在显著差异，尤其是在伸手和运送阶段，其全身运动比用勺和用嘴阶段更大。用勺阶段的手部方向变化比用嘴阶段更明显。PCA有助于确定关键的基本动作及其相应的喂食阶段，可用于评估喂食困难的患者并指导职业治疗干预。
{"title":"Normal feeding movements expressed by dimensionality reduction of whole-body joint motions using principal component analysis","authors":"Jun Nakatake, Shigeaki Miyazaki, Hideki Arakawa, Etsuo Chosa","doi":"10.1101/2024.09.14.24313686","DOIUrl":"https://doi.org/10.1101/2024.09.14.24313686","url":null,"abstract":"Understanding elementary feeding movements and postures is essential for improving assessment and intervention strategies in occupational therapy, particularly for individuals with eating difficulties, and for educating caregivers and students; however, current assessment tools lack precision in evaluating complex feeding movements and often rely on subjective judgments rather than objective measures. We aimed to determine elementary movements and postures corresponding to different feeding phases using principal component analysis (PCA). This cross-sectional observational study was conducted at a Local National University Hospital and included 45 healthy, right-handed adult volunteers (23 men and 22 women) aged 20–39 years (mean age, 27.3 years), with no neurological or musculoskeletal impairments. Movements during yogurt feeding using a spoon were captured with a three-dimensional inertial sensor motion capture system. Principal components (PCs) and their scores were derived from PCA of whole-body joint motion data across four feeding phases. PC scores were compared between phases using Friedman’s and post-hoc tests. The primary PC, representing whole-body movement, accounted for 50.0% of the variance; the second PC, associated with hand direction changes, accounted for 13.7%. The cumulative variance of the first six PCs was 87.4%, including individual body-part movements and fixations or combinations of these. Significant differences existed between feeding phases, particularly in the reaching and transport phases, which showed greater whole-body movement than that during the spooning and mouth phases. Hand direction changes were more prominent during the spooning phase than during the mouth phase. PCA helped determine key elementary movements and their corresponding feeding phases, which can be used to assess patients with feeding difficulties and guide occupational therapy interventions.","PeriodicalId":501453,"journal":{"name":"medRxiv - Rehabilitation Medicine and Physical Therapy","volume":"25 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142259604","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: This study aimed to investigate the effect of early postoperative ambulation on gait recovery at the initial postoperative week and at discharge after hip fracture surgery in older patients. Design: Multicenter prospective cohort study. Setting and Participants: The study included 882 patients aged ≥65 years from 10 acute hospitals in Japan. Methods: Patients were divided into two groups according to the interval between surgery and first ambulation: early-ambulation (EA) group (initiation of ambulation on postoperative day 1 or 2) and late-ambulation (LA) group (initiation of ambulation on postoperative day 3 or later). The Functional Independence Measure (FIM) was assessed 1 day postoperatively, 1 week postoperatively, and at discharge. Independent walking regardless of use of walking aids was defined as walking FIM ³5. Confounding variables were age, mobility and cognitive function before injury, medical history, fracture type, and waiting days for surgery. Multivariate logistic regression analysis was conducted to determine whether EA affected independent walking at 1 week postoperatively and at discharge. Results: The number of patients in the EA and LA groups was 292 (33.1%) and 590 (66.9%), respectively. The number of patients walking independently 1 week postoperatively and at discharge was 156 (17.7%) and 292 (33.1%), respectively. Multivariate logistic regression analysis revealed that EA was associated with independent walking at 1 week postoperatively (odds ratio [OR], 3.27; 95% confidence interval [CI], 2.17-4.94; P < .0001) and at discharge after adjusting for confounders (OR, 3.33; 95% CI, 2.38-4.69; P < .0001). EA was associated with the recovery to pre-injury walking status at discharge after adjusting for confounders (OR, 3.05; 95% CI, 1.59–5.93; P =.0009). Conclusion and Implications: Early ambulation after hip fracture surgery has an impact on independent walking and recovery of pre-injury walking status at 1 week postoperatively and at discharge from acute hospitals in older patients.
{"title":"Impact of early postoperative ambulation on gait recovery after hip fracture surgery: A multicenter cohort study","authors":"Keisuke Nakamura, Yasushi Kurobe, Keita Sue, Shinichi Sakurai, Tomohiro Sasaki, Shuhei Yamamoto, Naoko Ushiyama, Masahito Taga, Kimito Momose","doi":"10.1101/2024.09.12.24313534","DOIUrl":"https://doi.org/10.1101/2024.09.12.24313534","url":null,"abstract":"Objective: This study aimed to investigate the effect of early postoperative ambulation on gait recovery at the initial postoperative week and at discharge after hip fracture surgery in older patients.\u0000Design: Multicenter prospective cohort study.\u0000Setting and Participants: The study included 882 patients aged ≥65 years from 10 acute hospitals in Japan.\u0000Methods: Patients were divided into two groups according to the interval between surgery and first ambulation: early-ambulation (EA) group (initiation of ambulation on postoperative day 1 or 2) and late-ambulation (LA) group (initiation of ambulation on postoperative day 3 or later). The Functional Independence Measure (FIM) was assessed 1 day postoperatively, 1 week postoperatively, and at discharge. Independent walking regardless of use of walking aids was defined as walking FIM ³5. Confounding variables were age, mobility and cognitive function before injury, medical history, fracture type, and waiting days for surgery. Multivariate logistic regression analysis was conducted to determine whether EA affected independent walking at 1 week postoperatively and at discharge.\u0000Results: The number of patients in the EA and LA groups was 292 (33.1%) and 590 (66.9%), respectively. The number of patients walking independently 1 week postoperatively and at discharge was 156 (17.7%) and 292 (33.1%), respectively. Multivariate logistic regression analysis revealed that EA was associated with independent walking at 1 week postoperatively (odds ratio [OR], 3.27; 95% confidence interval [CI], 2.17-4.94; P < .0001) and at discharge after adjusting for confounders (OR, 3.33; 95% CI, 2.38-4.69; P < .0001). EA was associated with the recovery to pre-injury walking status at discharge after adjusting for confounders (OR, 3.05; 95% CI, 1.59–5.93; P =.0009).\u0000Conclusion and Implications: Early ambulation after hip fracture surgery has an impact on independent walking and recovery of pre-injury walking status at 1 week postoperatively and at discharge from acute hospitals in older patients.","PeriodicalId":501453,"journal":{"name":"medRxiv - Rehabilitation Medicine and Physical Therapy","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142259605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-13DOI: 10.1101/2024.09.11.24313519
Oluwole O. Awosika, Colin Drury, Amanda Garver, Pierce Boyne, Heidi Sucharew, Emily Wasik, Amit Bhattacharya, Kari Dunning, Pooja Khatri, Brett Kissela
Background and Purpose: Walking and balance impairments after stroke are a global health concern, causing significant morbidity and mortality. However, effective strategies for achieving meaningful recovery in the chronic stages are limited. Backward locomotor treadmill training (BLTT) is a novel walking rehabilitation protocol that is safe, feasible, and likely beneficial in stroke survivors; however, its efficacy has not been tested. This single-center, randomized, assessor-blind clinical trial aims to test the preliminary efficacy of BLTT compared to forward locomotor treadmill training (FLTT) on walking speed, symmetry, and postural stability. Methods: Forty stroke survivors [BLTT (N=19), FLTT (N=21); mean age= 56.3 ? 8.6 years; 53% Female; 30% Non-Hispanic Black] with mild-moderate walking impairment were enrolled. Participants underwent nine 30-minute BLTT or FLTT sessions over three weeks. The primary outcome was the mean change in the 10-meter walk test (10 MWT) at 24 hours post-training (24 hr POST). Secondary outcome measures were changes in spatiotemporal walking symmetry and postural stability during quiet standing at 24 hr POST. Retention was explored at Days 30- and 90 POST. Results: We report clinically meaningful (? 0.16 m/s) improvements in overground walking speed at 24 hr POST, with retention up to Day 90 POST with BLTT and FLTT. However, contrary to our working hypothesis, no between-group differences in walking speed were observed. Nonetheless, we found that BLTT resulted in offline improvements in spatial symmetry and retention of subcomponents of the modified clinical test of sensory interaction on balance (mCTSIB), including the testing of proprio-vestibular integration up to Day 30 POST. Conclusion: Among chronic stroke patients with mild-moderate walking impairment, BLTT and FLTT both resulted in long-lasting and clinically meaningful improvement in walking speed. However, preliminary findings suggest that BLTT may better comprehensively target walking asymmetry and sensory systems processing and integration.
{"title":"Backward Locomotor Treadmill Training on Walking and Balance Outcomes in Stroke Survivors: A Randomized Clinical Trial","authors":"Oluwole O. Awosika, Colin Drury, Amanda Garver, Pierce Boyne, Heidi Sucharew, Emily Wasik, Amit Bhattacharya, Kari Dunning, Pooja Khatri, Brett Kissela","doi":"10.1101/2024.09.11.24313519","DOIUrl":"https://doi.org/10.1101/2024.09.11.24313519","url":null,"abstract":"Background and Purpose: Walking and balance impairments after stroke are a global health concern, causing significant morbidity and mortality. However, effective strategies for achieving meaningful recovery in the chronic stages are limited. Backward locomotor treadmill training (BLTT) is a novel walking rehabilitation protocol that is safe, feasible, and likely beneficial in stroke survivors; however, its efficacy has not been tested. This single-center, randomized, assessor-blind clinical trial aims to test the preliminary efficacy of BLTT compared to forward locomotor treadmill training (FLTT) on walking speed, symmetry, and postural stability. Methods: Forty stroke survivors [BLTT (N=19), FLTT (N=21); mean age= 56.3 ? 8.6 years; 53% Female; 30% Non-Hispanic Black] with mild-moderate walking impairment were enrolled. Participants underwent nine 30-minute BLTT or FLTT sessions over three weeks. The primary outcome was the mean change in the 10-meter walk test (10 MWT) at 24 hours post-training (24 hr POST). Secondary outcome measures were changes in spatiotemporal walking symmetry and postural stability during quiet standing at 24 hr POST. Retention was explored at Days 30- and 90 POST. Results: We report clinically meaningful (? 0.16 m/s) improvements in overground walking speed at 24 hr POST, with retention up to Day 90 POST with BLTT and FLTT. However, contrary to our working hypothesis, no between-group differences in walking speed were observed. Nonetheless, we found that BLTT resulted in offline improvements in spatial symmetry and retention of subcomponents of the modified clinical test of sensory interaction on balance (mCTSIB), including the testing of proprio-vestibular integration up to Day 30 POST. Conclusion: Among chronic stroke patients with mild-moderate walking impairment, BLTT and FLTT both resulted in long-lasting and clinically meaningful improvement in walking speed. However, preliminary findings suggest that BLTT may better comprehensively target walking asymmetry and sensory systems processing and integration.","PeriodicalId":501453,"journal":{"name":"medRxiv - Rehabilitation Medicine and Physical Therapy","volume":"80 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142259607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-12DOI: 10.1101/2024.09.11.24313413
Irene Giovanna Aprile, Marco Germanotta, Alessio Fasano, Mariacristina Siotto, Maria Cristina Mauro, Arianna Pavan, Giovanna Nicora, Giuseppina Sgandurra, Alberto Malovini, Letizia Oreni, Nevio Dubbini, Enea Parimbelli, Giovanni Comandè, Christian Lunetta, Pietro Fiore, Roberto De Icco, Carlo Trompetto, Leopoldo Trieste, Giuseppe Turchetti, Silvana Quaglini, STROKEFIT4 study group
Introduction. Rehabilitation after stroke often employs Robots and Allied Digital Technologies (RADTs). However, evidence of their effectiveness remains inconclusive due to study heterogeneity and limited sample sizes. Here, we describe a protocol for a multicentre randomized controlled pragmatic trial aimed at comprehensively and accurately assessing the effectiveness and sustainability of RADT-mediated rehabilitation, compared to traditional rehabilitation. Methods and analysis. This is a pragmatic multicentre, multimodal, randomised, controlled, parallel-group (1:1) interventional study with blinded assessors. The trial will recruit 596 adult post-stroke patients in the subacute phase (less than 6 months post-stroke). Patients will be recruited from thirteen rehabilitation centres participating in a national research initiative, encompassing both outpatient and inpatient clinical settings. Participants will be randomized into either the experimental group, or the control group. The experimental group will receive rehabilitation using RADTs within a new organizational model, where two physical therapists supervise four to six patients; patients will undergo a comprehensive rehabilitation treatment, targeting the following domains: a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; d) cognitive abilities. In the control group, patients will undergo individual traditional rehabilitation, maintaining a 1:1 patient-to-therapist ratio, targeting the same domains. Patients will undergo a total of 25 sessions, each lasting 45 minutes, with a frequency of 5 times a week, for inpatients; and 3 times a week, for outpatients. The primary endpoint is to demonstrate non-inferiority in the recovery of the activities of daily living as measured by the modified Barthel Index. If non-inferiority is established, the study will then evaluate the superiority of RADTs in the recovery of the activities of daily living. Secondary endpoints include improvements in upper and lower limb function, balance, cognitive function, and, according to the ICF, in the body functions, activities, and participation domains. Additional analyses will cover neurophysiological assessments of neural plasticity, as well as biochemical, and genetic evaluations. Upper limb dexterity and gait recovery rates during treatment will be monitored. The study will also evaluate daily activities and quality of life during a six-month follow-up period post-treatment. Acceptability and usability of integrated RADTs-based rehabilitation for patients, families, and healthcare providers, along with economic and organizational sustainability for patients, payers, and society, will also be assessed. Outcomes will be measured and analysed by blinded assessors. Ethics and dissemination. This study was reviewed and approved by National Ethics Committee for clinical trials of Public Research Bodies (EPR) and other National Public Institutions (CEN). The results wi
{"title":"Rehabilitation with and without Robot and Allied Digital Technologies (RADTs) in stroke patients: a study protocol for a multicentre Randomised Controlled Trial on the effectiveness, acceptability, usability, and economic-organizational sustainability of RADTs from subacute to chronic phase (STROKEFIT4)","authors":"Irene Giovanna Aprile, Marco Germanotta, Alessio Fasano, Mariacristina Siotto, Maria Cristina Mauro, Arianna Pavan, Giovanna Nicora, Giuseppina Sgandurra, Alberto Malovini, Letizia Oreni, Nevio Dubbini, Enea Parimbelli, Giovanni Comandè, Christian Lunetta, Pietro Fiore, Roberto De Icco, Carlo Trompetto, Leopoldo Trieste, Giuseppe Turchetti, Silvana Quaglini, STROKEFIT4 study group","doi":"10.1101/2024.09.11.24313413","DOIUrl":"https://doi.org/10.1101/2024.09.11.24313413","url":null,"abstract":"Introduction. Rehabilitation after stroke often employs Robots and Allied Digital Technologies (RADTs). However, evidence of their effectiveness remains inconclusive due to study heterogeneity and limited sample sizes. Here, we describe a protocol for a multicentre randomized controlled pragmatic trial aimed at comprehensively and accurately assessing the effectiveness and sustainability of RADT-mediated rehabilitation, compared to traditional rehabilitation.\u0000Methods and analysis. This is a pragmatic multicentre, multimodal, randomised, controlled, parallel-group (1:1) interventional study with blinded assessors. The trial will recruit 596 adult post-stroke patients in the subacute phase (less than 6 months post-stroke). Patients will be recruited from thirteen rehabilitation centres participating in a national research initiative, encompassing both outpatient and inpatient clinical settings. Participants will be randomized into either the experimental group, or the control group. The experimental group will receive rehabilitation using RADTs within a new organizational model, where two physical therapists supervise four to six patients; patients will undergo a comprehensive rehabilitation treatment, targeting the following domains: a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; d) cognitive abilities. In the control group, patients will undergo individual traditional rehabilitation, maintaining a 1:1 patient-to-therapist ratio, targeting the same domains. Patients will undergo a total of 25 sessions, each lasting 45 minutes, with a frequency of 5 times a week, for inpatients; and 3 times a week, for outpatients. The primary endpoint is to demonstrate non-inferiority in the recovery of the activities of daily living as measured by the modified Barthel Index. If non-inferiority is established, the study will then evaluate the superiority of RADTs in the recovery of the activities of daily living. Secondary endpoints include improvements in upper and lower limb function, balance, cognitive function, and, according to the ICF, in the body functions, activities, and participation domains. Additional analyses will cover neurophysiological assessments of neural plasticity, as well as biochemical, and genetic evaluations. Upper limb dexterity and gait recovery rates during treatment will be monitored. The study will also evaluate daily activities and quality of life during a six-month follow-up period post-treatment. Acceptability and usability of integrated RADTs-based rehabilitation for patients, families, and healthcare providers, along with economic and organizational sustainability for patients, payers, and society, will also be assessed. Outcomes will be measured and analysed by blinded assessors.\u0000Ethics and dissemination. This study was reviewed and approved by National Ethics Committee for clinical trials of Public Research Bodies (EPR) and other National Public Institutions (CEN). The results wi","PeriodicalId":501453,"journal":{"name":"medRxiv - Rehabilitation Medicine and Physical Therapy","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142217357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-12DOI: 10.1101/2024.09.10.24313424
Joris Boulo, Margaux Simon, Bradford James McFadyen, Andreanne Blanchette
Navigating public environments requires adjustments to one s walking patterns to avoid stationary and moving obstacles. It is known that physical inactivity induces alterations in motor capacities, but the impact of inactivity on anticipatory locomotor adjustments (ALA) has not been studied. The purpose of the present study was to compare ALAs and related muscle co-contraction during a pedestrian circumvention task between active (AA) and inactive young adults (IA). Thirteen AA and thirteen IA were placed in a virtual environment simulating a public park. Participants circumvented virtual pedestrians walking towards them. Walking speed, onset of deviation, clearance, foot placement strategies and muscle co-contraction were analysed. IA exhibited slower walking speeds compared to the AA during circumvention condition but not during unobstructed walking condition. The distance at the onset of trajectory deviation was larger for IA. Both groups increased co-contraction for pedestrian circumvention at the ankle and left hip and IA displayed greater ankle co-contraction overall. No significant group differences were observed in minimum clearance. This study suggests that an inactive lifestyle influences ALAs by inducing a cautious behavior during pedestrian circumvention.
在公共环境中行走需要调整行走方式，以避开静止和移动的障碍物。众所周知，不运动会导致运动能力的改变，但不运动对预期运动调整（ALA）的影响尚未研究过。本研究的目的是比较活跃的年轻人（AA）和不活跃的年轻人（IA）在行人绕行任务中的预期运动调整（ALA）和相关肌肉共收缩。13 名 AA 和 13 名 IA 被放置在一个模拟公共公园的虚拟环境中。参与者绕过朝他们走来的虚拟行人。对步行速度、偏离开始时间、间隙、脚的放置策略和肌肉协同收缩进行了分析。在绕行条件下，IA的行走速度比AA慢，但在无障碍行走条件下则不然。IA 开始偏离轨迹时的距离更大。两组在行人绕行时，踝关节和左髋关节的共收缩都有所增加，而 IA 组的踝关节共收缩总体上更大。在最小间隙方面没有观察到明显的组间差异。这项研究表明，不活跃的生活方式会通过诱导行人绕行时的谨慎行为来影响 ALAs。
{"title":"EFFECTS OF LIFESTYLE ACTIVITY LEVEL ON ANTICIPATORY LOCOMOTOR ADJUSTMENTS FOR PEDESTRIAN CIRCUMVENTION","authors":"Joris Boulo, Margaux Simon, Bradford James McFadyen, Andreanne Blanchette","doi":"10.1101/2024.09.10.24313424","DOIUrl":"https://doi.org/10.1101/2024.09.10.24313424","url":null,"abstract":"Navigating public environments requires adjustments to one s walking patterns to avoid stationary and moving obstacles. It is known that physical inactivity induces alterations in motor capacities, but the impact of inactivity on anticipatory locomotor adjustments (ALA) has not been studied. The purpose of the present study was to compare ALAs and related muscle co-contraction during a pedestrian circumvention task between active (AA) and inactive young adults (IA). Thirteen AA and thirteen IA were placed in a virtual environment simulating a public park. Participants circumvented virtual pedestrians walking towards them. Walking speed, onset of deviation, clearance, foot placement strategies and muscle co-contraction were analysed. IA exhibited slower walking speeds compared to the AA during circumvention condition but not during unobstructed walking condition. The distance at the onset of trajectory deviation was larger for IA. Both groups increased co-contraction for pedestrian circumvention at the ankle and left hip and IA displayed greater ankle co-contraction overall. No significant group differences were observed in minimum clearance. This study suggests that an inactive lifestyle influences ALAs by inducing a cautious behavior during pedestrian circumvention.","PeriodicalId":501453,"journal":{"name":"medRxiv - Rehabilitation Medicine and Physical Therapy","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142217329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-07DOI: 10.1101/2024.09.06.24313226
Lisa Bjork, Jenny Hultquist, Gunnel Hensing, Monica Bertilsson
The aim of this study was to assess industry differences in managers' experiences and ratings of work capacity in employees with common mental disorders (CMDs). Swedish managers (N=1819) were grouped into three industry classifications. Differences between industries in managers’ experiences were investigated by chi-squared tests. The managers’ ratings of how work capacity was affected by CMDs were analysed using MANCOVA, adjusted for organizational size and managers’ span of control. The proportion of managers who had experienced several employees with CMDs was higher in municipalities and counties, and in pink-collar work, education, health and social care settings compared with other industries. There was no significant effect of industry on managers’ ratings of how work capacity may be affected by CMDs. Contrary to assumptions, there were no differences in how managers perceived capacity to work between industries. Therefore, it is more urgent that managers receive the support they need to handle employees with reduced work capacity due to CMDs rather than to tailor such support to different industries.
{"title":"Industry differences in managers’ experiences of work capacity in employees with common mental disorders: a cross-sectional study on the Swedish labour market","authors":"Lisa Bjork, Jenny Hultquist, Gunnel Hensing, Monica Bertilsson","doi":"10.1101/2024.09.06.24313226","DOIUrl":"https://doi.org/10.1101/2024.09.06.24313226","url":null,"abstract":"The aim of this study was to assess industry differences in managers' experiences and ratings of work capacity in employees with common mental disorders (CMDs). Swedish managers (N=1819) were grouped into three industry classifications. Differences between industries in managers’ experiences were investigated by chi-squared tests. The managers’ ratings of how work capacity was affected by CMDs were analysed using MANCOVA, adjusted for organizational size and managers’ span of control. The proportion of managers who had experienced several employees with CMDs was higher in municipalities and counties, and in pink-collar work, education, health and social care settings compared with other industries. There was no significant effect of industry on managers’ ratings of how work capacity may be affected by CMDs. Contrary to assumptions, there were no differences in how managers perceived capacity to work between industries. Therefore, it is more urgent that managers receive the support they need to handle employees with reduced work capacity due to CMDs rather than to tailor such support to different industries.","PeriodicalId":501453,"journal":{"name":"medRxiv - Rehabilitation Medicine and Physical Therapy","volume":"21 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142217325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-06DOI: 10.1101/2024.09.05.24313041
Dingkun Liu, Yongzhi Shan, Penghu Wei, Wenzheng Li, Honglai Xu, Fangshuo Liang, Tao Liu, Guoguang Zhao, Bo Hong
Spinal cord injuries significantly impair patients' ability to perform daily activities independently. While invasive brain-computer interfaces (BCIs) offer high communication bandwidth to assist and rehabilitate these patients, their invasiveness limits broader adoption. We developed a minimally invasive BCI system that balances safety and communication bandwidth to restore hand functions. This system enables real-time, precise control of hand movements and effective hand function rehabilitation, requiring less than 10 minutes of calibration time and maintaining an average grasping detection F1-score of 0.91 over a 9-month period of home use. A tetraplegia patient caused by complete spinal cord injury was recruited in this study. With the assistance of the brain-computer interface, the patient can successfully perform object grasping and daily tasks involving hand functions, achieving a 100% success rate in an object transfer test. Additionally, the patient showed substantial neurological recovery through consecutive BCI upper limb training, regaining the ability to hold objects without BCI assistance. The patient demonstrated a 5-point improvement in ISNCSCI upper limb motor scores and a 27-point increase in the Action Research Arm Test (ARAT). Improvements in electrophysiological assessments point to a considerable recovery in impaired neural circuits. The cerebral-spinal channels established via this BCI system offer a promising new approach for treating spinal cord injuries and restoring hand functions.
{"title":"Reclaiming Motor Functions after Complete Spinal Cord Injury using Epidural Minimally Invasive Brain-Computer Interface","authors":"Dingkun Liu, Yongzhi Shan, Penghu Wei, Wenzheng Li, Honglai Xu, Fangshuo Liang, Tao Liu, Guoguang Zhao, Bo Hong","doi":"10.1101/2024.09.05.24313041","DOIUrl":"https://doi.org/10.1101/2024.09.05.24313041","url":null,"abstract":"Spinal cord injuries significantly impair patients' ability to perform daily activities independently. While invasive brain-computer interfaces (BCIs) offer high communication bandwidth to assist and rehabilitate these patients, their invasiveness limits broader adoption. We developed a minimally invasive BCI system that balances safety and communication bandwidth to restore hand functions. This system enables real-time, precise control of hand movements and effective hand function rehabilitation, requiring less than 10 minutes of calibration time and maintaining an average grasping detection F1-score of 0.91 over a 9-month period of home use. A tetraplegia patient caused by complete spinal cord injury was recruited in this study. With the assistance of the brain-computer interface, the patient can successfully perform object grasping and daily tasks involving hand functions, achieving a 100% success rate in an object transfer test. Additionally, the patient showed substantial neurological recovery through consecutive BCI upper limb training, regaining the ability to hold objects without BCI assistance. The patient demonstrated a 5-point improvement in ISNCSCI upper limb motor scores and a 27-point increase in the Action Research Arm Test (ARAT). Improvements in electrophysiological assessments point to a considerable recovery in impaired neural circuits. The cerebral-spinal channels established via this BCI system offer a promising new approach for treating spinal cord injuries and restoring hand functions.","PeriodicalId":501453,"journal":{"name":"medRxiv - Rehabilitation Medicine and Physical Therapy","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142217327","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-06DOI: 10.1101/2024.09.06.24313094
Philip Hodgson, Alastair Jordan, Charikleia Sinani, Divine Charura
Background: People with Parkinson's (PwP) can experience both physical and psychological symptoms, and understanding the perspectives of people affected is crucial for improved management, and clinical outcomes. Objectives: This online survey sought to investigate whether individuals perceive a connection between physical and psychological symptoms, while also considering the influence of personal roles and past symptom experiences. Methods: A UK-wide survey of 251 PwP and 61 family/carers was conducted. The survey focused on reported diagnosed and non-diagnosed psychological symptoms experienced, their onset, and the perceived impact of physical and psychological symptoms on one another. Responses were summarised using descriptive statistics. Results: A substantial proportion of respondents reported at least one diagnosed psychological condition (38.5%) or undiagnosed psychological symptoms (44.6%) such as anxiety and depression. Half of respondents reported perceiving a bi-directional interaction between physical and psychological symptoms, with this perception most reported in people with prior experience of psychological symptoms. Our sample shows that while PwP and carers have similar views on the impact of psychological symptoms, carers perceive the impact of physical symptoms to be greater than PwP. Conclusions: PwP and carers appear to perceive an interaction between physical and psychological symptoms in Parkinson's, noting that psychological symptoms frequently precede Parkinson's diagnosis but are often under-recognised. Improved awareness of the potential link between physical and psychological symptoms in PwP may help to improve assessment, and onward referral processes to enhance care. Further research may assist in identifying potential sub-groups and allow the prediction of changes in physical and psychological presentation.
{"title":"The relationship between physical function and psychological symptoms in Parkinson's: A Survey of People with Parkinson’s and Carers","authors":"Philip Hodgson, Alastair Jordan, Charikleia Sinani, Divine Charura","doi":"10.1101/2024.09.06.24313094","DOIUrl":"https://doi.org/10.1101/2024.09.06.24313094","url":null,"abstract":"Background: People with Parkinson's (PwP) can experience both physical and psychological symptoms, and understanding the perspectives of people affected is crucial for improved management, and clinical outcomes.\u0000Objectives: This online survey sought to investigate whether individuals perceive a connection between physical and psychological symptoms, while also considering the influence of personal roles and past symptom experiences.\u0000Methods: A UK-wide survey of 251 PwP and 61 family/carers was conducted. The survey focused on reported diagnosed and non-diagnosed psychological symptoms experienced, their onset, and the perceived impact of physical and psychological symptoms on one another. Responses were summarised using descriptive statistics.\u0000Results: A substantial proportion of respondents reported at least one diagnosed psychological condition (38.5%) or undiagnosed psychological symptoms (44.6%) such as anxiety and depression. Half of respondents reported perceiving a bi-directional interaction between physical and psychological symptoms, with this perception most reported in people with prior experience of psychological symptoms. Our sample shows that while PwP and carers have similar views on the impact of psychological symptoms, carers perceive the impact of physical symptoms to be greater than PwP.\u0000Conclusions: PwP and carers appear to perceive an interaction between physical and psychological symptoms in Parkinson's, noting that psychological symptoms frequently precede Parkinson's diagnosis but are often under-recognised. Improved awareness of the potential link between physical and psychological symptoms in PwP may help to improve assessment, and onward referral processes to enhance care. Further research may assist in identifying potential sub-groups and allow the prediction of changes in physical and psychological presentation.","PeriodicalId":501453,"journal":{"name":"medRxiv - Rehabilitation Medicine and Physical Therapy","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142217326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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