Implementation of an Advanced Telerehabilitation Solution for People With Multiple Sclerosis

NCT07310914 — Phase 2, Not yet recruiting, 94 participants, Danish Multiple Sclerosis Hospitals

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Registry	NCT07310914, acronym PLATINUMS
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	94 (Estimated)
Sponsor	Danish Multiple Sclerosis Hospitals (Other); collaborators: MS Ireland, Tel Aviv University, University of Cagliari, University of Limerick
Conditions	Multiple Sclerosis
Interventions	Telerehabilitation, Paper-based exercise (Behavioral)
Dates	start 2026-02-01 (estimated), primary completion 2026-12-31 (estimated), completion 2027-07-01 (estimated), first posted 2025-12-30, last updated 2025-12-30
Locations	5 sites in Denmark, Ireland, Israel, Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Experimental	Experimental	Behavioral: Telerehabilitation	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.
Paper-based instructions	Active comparator	Behavioral: Paper-based exercise	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

Telerehabilitation (Behavioral): Advanced telerehabilitation with a program made by specialized physiotherapists and delivered through the WizeCare system.
Paper-based exercise (Behavioral): Paper-based exercise instructions made by specialized physiotherapists.

+Outcome measures

Primary outcomes

30 second sit to stand test [Baseline to 10 weeks]: Measure of lower extremity muscle power and a proxy measure of mobility

Secondary outcomes

Short Physical Performance Battery [Baseline to 10 weeks]: Meaure of balance, walking function and lower extremity muscle strength
Functional Reach Test [Baseline to 10 weeks]: A measure of stability
Timed 25 feet foot walk test [Baseline to 10 weeks]: A measure of walking speed
MiniBESTest [Baseline to 10 weeks]: A measure of balance
Six minute walk test [Baseline to 10 weeks]: A measure of walking endurance
Modified Fatigue Impact Scale [Baseline]: Patient-reported measure of fatigue
12 item Multiple Sclerosis Walking Scale [Baseline to 10 weeks]: Patient-reported outcome of walking function
Multiple Sclerosis Impact Scale [Baseline to 10 weeks]: Patient-reported measure on the impact of multiple sclerosis
EQ-5D-5L [Baseline to 10 weeks]: Patient-reported measure of quality of life
State-Trait Anxiety Inventory [Baseline to 10 weeks]: Patient-reported measure of anxiety
Quick Inventory of Depression Symptomology [Baseline to 10 weeks]: Patient-reported measure of depressive symptoms
Client Services Receipt Inventory [Baseline to 10 weeks]: Patient-reported measure of used health services
Digital Health Literacy Scale [Baseline]: Patient-reported measure of digital health literacy
Telehealth Usability Questionnaire [10 weeks]: Patient-reported measure of telehealth usability
Semi-structed interview [10 weeks]: A semi-structured interview on the satisfaction with the telerehabilitation system

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (5)

Facility	City	Country
The Danish MS Hospitals, Haslev	Haslev	Denmark
The Danish MS Hospitals, Ry	Ry	Denmark
MS Ireland	Dublin	Ireland
Tel Aviv University	Tel Aviv	Israel
University of Cagliari	Cagliari	Italy

+Publications

Results publication: Taul-Madsen L, Hvid LG, Casu G, Pau M, Synnott E, Coote S, Alt Y, Kalron A. Protocol for a pilot effectiveness and feasibility randomized controlled trial of an advanced telerehabilitation system for people with multiple sclerosis (PLATINUMS project). PLoS One. 2026 Aug 18;21(8):e0355376. doi: 10.1371/journal.pone.0355376. eCollection 2026. PMID 42611888