NCT07310914
Not yet recruiting
Phase 2
Implementation of an Advanced Telerehabilitation Solution for People With Multiple Sclerosis
Danish Multiple Sclerosis Hospitals5 sites in 4 countries94 target enrollmentStarted: February 1, 2026Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Danish Multiple Sclerosis Hospitals
- Enrollment
- 94
- Locations
- 5
- Primary Endpoint
- 30 second sit to stand test
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
30 second sit to stand test
Time Frame: Baseline to 10 weeks
Measure of lower extremity muscle power and a proxy measure of mobility
Secondary Outcomes
- 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)
Investigators
Lars Hvid
Senior Researcher, PHD
Danish Multiple Sclerosis Hospitals
Study Sites (5)
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