Anna L Hatton, Katrina Williams, Mark D Chatfield, Sheree Hurn, Jayishni N Maharaj, Elise M Gane, Thomas Cattagni, John Dixon, Keith Rome, Graham Kerr, Sandra G Brauer
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Thirty ambulant men and women with multiple sclerosis (MS) (Disease Steps rating 1-4) were randomly allocated to wear textured or smooth insoles for 12 weeks. Self-reported insole wear and falls diaries were completed over the intervention period. Laboratory assessments of spatiotemporal gait patterns, foot sensation and proprioception, and patient-reported outcomes, were performed at Weeks 0 (Baseline 1), 4 (Baseline 2) and 16 (Post-Intervention). The primary outcome was the size of the mediolateral base of support (stride/step width) when walking over even and uneven surfaces. Independent <i>t</i>-tests were performed on change from baseline (average of baseline measures) to post-intervention.</p><p><strong>Results: </strong>There were no differences in stride width between groups, when walking over the even or uneven surfaces (<i>P</i> ≥ 0.20) at post-intervention. There were no between-group differences for any secondary outcomes including gait (all <i>P</i> values > 0.23), foot sensory function (all <i>P</i> values ≥ 0.08) and patient-reported outcomes (all <i>P</i> values ≥ 0.23).</p><p><strong>Conclusions: </strong>In our small trial, prolonged wear of textured insoles did not appear to alter walking or foot sensation in people with MS who have limited foot sensory loss. Further investigation is needed to explore optimal insole design.</p><p><strong>Clinical trial registration: </strong>Australian and New Zealand Clinical Trials Registry (ACTRN12615000421538).</p>","PeriodicalId":56329,"journal":{"name":"Brain Impairment","volume":null,"pages":null},"PeriodicalIF":1.1000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effects of wearing textured versus smooth shoe insoles for 12 weeks on gait, foot sensation and patient-reported outcomes, in people with multiple sclerosis: a randomised controlled trial.\",\"authors\":\"Anna L Hatton, Katrina Williams, Mark D Chatfield, Sheree Hurn, Jayishni N Maharaj, Elise M Gane, Thomas Cattagni, John Dixon, Keith Rome, Graham Kerr, Sandra G Brauer\",\"doi\":\"10.1017/BrImp.2022.33\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Innovative shoe insoles, designed to enhance sensory information on the plantar surface of the feet, could help to improve walking in people with Multiple Sclerosis.</p><p><strong>Objective: </strong>To compare the effects of wearing textured versus smooth insoles, on measures of gait, foot sensation and patient-reported outcomes, in people with Multiple Sclerosis.</p><p><strong>Methods: </strong>A prospective, randomised controlled trial was conducted with concealed allocation, assessor blinding and intention-to-treat analysis. Thirty ambulant men and women with multiple sclerosis (MS) (Disease Steps rating 1-4) were randomly allocated to wear textured or smooth insoles for 12 weeks. Self-reported insole wear and falls diaries were completed over the intervention period. Laboratory assessments of spatiotemporal gait patterns, foot sensation and proprioception, and patient-reported outcomes, were performed at Weeks 0 (Baseline 1), 4 (Baseline 2) and 16 (Post-Intervention). The primary outcome was the size of the mediolateral base of support (stride/step width) when walking over even and uneven surfaces. Independent <i>t</i>-tests were performed on change from baseline (average of baseline measures) to post-intervention.</p><p><strong>Results: </strong>There were no differences in stride width between groups, when walking over the even or uneven surfaces (<i>P</i> ≥ 0.20) at post-intervention. There were no between-group differences for any secondary outcomes including gait (all <i>P</i> values > 0.23), foot sensory function (all <i>P</i> values ≥ 0.08) and patient-reported outcomes (all <i>P</i> values ≥ 0.23).</p><p><strong>Conclusions: </strong>In our small trial, prolonged wear of textured insoles did not appear to alter walking or foot sensation in people with MS who have limited foot sensory loss. 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引用次数: 0
摘要
背景：旨在增强多发性硬化症患者足底感觉信息的创新鞋垫有助于改善他们的行走状况：旨在增强足底感觉信息的创新鞋垫有助于改善多发性硬化症患者的行走状况：比较穿着纹理鞋垫和光滑鞋垫对多发性硬化症患者步态、足部感觉和患者报告结果的影响：方法： 我们进行了一项前瞻性随机对照试验，试验采用隐蔽分配、评估者盲法和意向治疗分析法。30名患有多发性硬化症（MS）（疾病分级为1-4级）的男性和女性患者被随机分配穿戴纹理鞋垫或光滑鞋垫，为期12周。在干预期间完成自我报告的鞋垫穿着情况和跌倒日记。在第 0 周（基线 1）、第 4 周（基线 2）和第 16 周（干预后）对时空步态模式、足部感觉和本体感觉以及患者报告的结果进行实验室评估。主要结果是在平坦和不平坦路面上行走时内侧支撑基底的大小（步幅/步宽）。对从基线（基线测量的平均值）到干预后的变化进行独立 t 检验：结果：干预后，在平坦或不平坦路面上行走时，各组间步幅无差异（P≥0.20）。在步态（所有 P 值均>0.23）、足部感觉功能（所有 P 值均≥0.08）和患者报告结果（所有 P 值均≥0.23）等次要结果方面，组间均无差异：结论：在我们的小规模试验中，长期穿着纹理鞋垫似乎不会改变有局限性足部感觉缺失的多发性硬化症患者的行走或足部感觉。临床试验注册：临床试验注册：澳大利亚和新西兰临床试验注册中心（ACTRN12615000421538）。
Effects of wearing textured versus smooth shoe insoles for 12 weeks on gait, foot sensation and patient-reported outcomes, in people with multiple sclerosis: a randomised controlled trial.
Background: Innovative shoe insoles, designed to enhance sensory information on the plantar surface of the feet, could help to improve walking in people with Multiple Sclerosis.
Objective: To compare the effects of wearing textured versus smooth insoles, on measures of gait, foot sensation and patient-reported outcomes, in people with Multiple Sclerosis.
Methods: A prospective, randomised controlled trial was conducted with concealed allocation, assessor blinding and intention-to-treat analysis. Thirty ambulant men and women with multiple sclerosis (MS) (Disease Steps rating 1-4) were randomly allocated to wear textured or smooth insoles for 12 weeks. Self-reported insole wear and falls diaries were completed over the intervention period. Laboratory assessments of spatiotemporal gait patterns, foot sensation and proprioception, and patient-reported outcomes, were performed at Weeks 0 (Baseline 1), 4 (Baseline 2) and 16 (Post-Intervention). The primary outcome was the size of the mediolateral base of support (stride/step width) when walking over even and uneven surfaces. Independent t-tests were performed on change from baseline (average of baseline measures) to post-intervention.
Results: There were no differences in stride width between groups, when walking over the even or uneven surfaces (P ≥ 0.20) at post-intervention. There were no between-group differences for any secondary outcomes including gait (all P values > 0.23), foot sensory function (all P values ≥ 0.08) and patient-reported outcomes (all P values ≥ 0.23).
Conclusions: In our small trial, prolonged wear of textured insoles did not appear to alter walking or foot sensation in people with MS who have limited foot sensory loss. Further investigation is needed to explore optimal insole design.
Clinical trial registration: Australian and New Zealand Clinical Trials Registry (ACTRN12615000421538).
期刊介绍：
The journal addresses topics related to the aetiology, epidemiology, treatment and outcomes of brain impairment with a particular focus on the implications for functional status, participation, rehabilitation and quality of life. Disciplines reflect a broad multidisciplinary scope and include neuroscience, neurology, neuropsychology, psychiatry, clinical psychology, occupational therapy, physiotherapy, speech pathology, social work, and nursing. Submissions are welcome across the full range of conditions that affect brain function (stroke, tumour, progressive neurological illnesses, dementia, traumatic brain injury, epilepsy, etc.) throughout the lifespan.
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