Implementation of an Advanced Telerehabilitation Solution for People With Multiple Sclerosis (PLATINUMS)

Danish Multiple Sclerosis Hospitals

Status and phase: Not yet enrolling; Phase 2

Conditions: Multiple Sclerosis

Treatments: Behavioral: Paper-based exercise; Behavioral: Telerehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT07310914

Telerehabilitation in PWMS

Details and patient eligibility

About

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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Experimental

Experimental group

Description:

10 weeks of home-based exercise performed with the telerehabilitation system. Partipicants will perform two sessions per week (30-45 minutes). The content of the exercise program and the specific exercises will be planned by specialized physiotherapists.

Treatment:

Behavioral: Telerehabilitation

Paper-based instructions

Active Comparator group

Description:

10 weeks of home-based exercise with paper-based instructions. Partipicants will perform two sessions per week (30-45 minutes). The content of the exercise program and the specific exercises will be planned by specialized physiotherapists.Paper-based exercise instructions

Treatment:

Behavioral: Paper-based exercise