NCT07310914尚未招募2 期
Implementation of an Advanced Telerehabilitation Solution for People With Multiple Sclerosis
Danish Multiple Sclerosis Hospitals7 个研究点 分布在 4 个国家目标入组 94 人开始时间: 2026年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 7
- 主要终点
- 30 second sit to stand test
研究概览
简要总结
The overall purpose of the present study is to investigate the effect of an advanced telerehablitation system (TRS) in persons with multiple sclerosis on mobility. The advanced telerhabilitation system is based on AI components, and delivers instant feedback to the partcipants. If the project is successful, it can help optimize exercise for those persons with multiple sclerosis who are either not able or willing to travel to a clinical setting for exericse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite diagnosis of MS according to the McDonald criteria (both relapse-remitting and progressive)
- •Expanded Disability Status Scale (EDSS) score of 2.5 to 6.5 or Patient Determined Disability Score (PDDS) of 2 to 6, indicating preservation of at least some ambulatory function, that is, the ability to walk 20 meters or more, independently, with or without the use of an assistive device
- •Willingness to travel to the local study site for the evaluation sessions,
- •Internet platform availability
排除标准
- •comorbidities hindering participation in the study.
- •Individuals who have had a documented relapse and/or corticoid treatment during the past three months will be excluded,
- •Individuals with severe cognitive deficits who cannot follow simple instructions and/or consent.
结局指标
主要结局
30 second sit to stand test
时间窗: Baseline to 10 weeks
Measure of lower extremity muscle power and a proxy measure of mobility
次要结局
- MiniBESTest(Baseline to 10 weeks)
- Six minute walk test(Baseline to 10 weeks)
- Functional Reach Test(Baseline to 10 weeks)
- Short Physical Performance Battery(Baseline to 10 weeks)
- 12 item Multiple Sclerosis Walking Scale(Baseline to 10 weeks)
- Timed 25 feet foot walk test(Baseline to 10 weeks)
- Digital Health Literacy Scale(Baseline)
- Modified Fatigue Impact Scale(Baseline)
- EQ-5D-5L(Baseline to 10 weeks)
- Multiple Sclerosis Impact Scale(Baseline to 10 weeks)
- State-Trait Anxiety Inventory(Baseline to 10 weeks)
- Quick Inventory of Depression Symptomology(Baseline to 10 weeks)
- Client Services Receipt Inventory(Baseline to 10 weeks)
- Telehealth Usability Questionnaire(10 weeks)
- Semi-structed interview(10 weeks)
研究者
Lars Hvid
Senior Researcher, PHD
Danish Multiple Sclerosis Hospitals
研究点 (7)
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