A Randomized Clinical Trial to Evaluate a Digital Therapeutic to Enhance Gait Function in Individuals With Parkinson's Disease.

IF 3.7 2区 医学 Q1 CLINICAL NEUROLOGY Neurorehabilitation and Neural Repair Pub Date : 2023-09-01 Epub Date: 2023-07-19 DOI:10.1177/15459683231184190
Jay L Alberts, Ryan D Kaya, Amanda L Penko, Matthew Streicher, Eric M Zimmerman, Sara Davidson, Benjamin L Walter, Anson B Rosenfeldt
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引用次数: 1

Abstract

Background: Postural instability and gait dysfunction (PIGD) is a cardinal symptom of Parkinson's disease (PD) and is exacerbated under dual-task conditions. Dual-task training (DTT), enhances gait performance, however it is time and cost intensive. Digitizing DTT via the Dual-task Augmented Reality Treatment (DART) platform can expand the availability of an effective intervention to address PIGD.

Objective: The aim of this project was to evaluate DART in the treatment of PIGD in people with PD compared to a Traditional DTT intervention. It was hypothesized that both groups would exhibit significant improvements in gait, and the improvements for the DART group would be non-inferior to Traditional DTT.

Methods: A single-blind randomized controlled trial was conducted with 47 PD participants with PIGD. Both groups completed 16 therapeutic sessions over 8 weeks; the DART platform delivered DTT via the Microsoft HoloLens2. Primary outcomes included clinical ratings and single- and dual-task gait biomechanical outcomes.

Results: Clinical measures of PD symptoms remained stable for DART and Traditional DTT groups. However, both groups exhibited a significant increase in gait velocity, cadence, and step length during single- and multiple dual-task conditions following the interventions. Improvements in gait velocity in the DART group were non-inferior to Traditional DTT under the majority of conditions.

Conclusion: Non-inferior improvements in gait parameters across groups provides evidence of the DART platform being an effective digital therapeutic capable of improving PIGD. Effective digital delivery of DTT has the potential to increase use and accessibility to a promising, yet underutilized and difficult to administer, intervention for PIGD.

Clinical trial registration: ClinicalTrials.gov Dual-task Augmented Reality Treatment for Parkinson's Disease (DART) NCT04634331; posted November 18, 2020.

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评估增强帕金森病患者步态功能的数字疗法的随机临床试验。
背景:姿势不稳定和步态功能障碍(PIGD)是帕金森病(PD)的主要症状,在双重任务条件下会加剧。双任务训练(DTT),提高步态性能,但它是时间和成本密集型的。通过双任务增强现实治疗(DART)平台数字化DTT可以扩大有效干预措施的可用性,以解决PIGD问题。目的:本项目的目的是评估DART与传统DTT干预相比在PD患者PIGD治疗中的作用。假设两组步态都会有显著改善,DART组的改善程度不会低于传统DTT。方法:采用单盲随机对照试验对47名患有PIGD的帕金森病患者进行研究。两组均在8个疗程内完成了16次治疗 周;DART平台通过Microsoft HoloLens2提供DTT。主要结果包括临床评分和单任务和双任务步态生物力学结果。结果:DART和传统DTT组的PD症状的临床指标保持稳定。然而,在干预后的单任务和多任务双重条件下,两组的步态速度、节奏和步长都显著增加。在大多数情况下,DART组步态速度的改善并不劣于传统DTT。结论:各组步态参数的非劣性改善为DART平台是一种有效的数字治疗方法,能够改善PIGD提供了证据。DTT的有效数字交付有可能增加PIGD干预措施的使用和可及性,这是一种有前景但未充分利用且难以管理的干预措施。临床试验注册:ClinicalTrials.gov帕金森病双任务增强现实治疗(DART)NCT04634331;发布于2020年11月18日。
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来源期刊
CiteScore
8.30
自引率
4.80%
发文量
52
审稿时长
6-12 weeks
期刊介绍: Neurorehabilitation & Neural Repair (NNR) offers innovative and reliable reports relevant to functional recovery from neural injury and long term neurologic care. The journal''s unique focus is evidence-based basic and clinical practice and research. NNR deals with the management and fundamental mechanisms of functional recovery from conditions such as stroke, multiple sclerosis, Alzheimer''s disease, brain and spinal cord injuries, and peripheral nerve injuries.
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