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

December 16, 2025 updated by: Lars Hvid, Danish Multiple Sclerosis Hospitals
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
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.
Behavioral: Telerehabilitation
Advanced telerehabilitation with a program made by specialized physiotherapists and delivered through the WizeCare system.
Active Comparator: Paper-based instructions
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
Behavioral: Paper-based exercise
Paper-based exercise instructions made by specialized physiotherapists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 second sit to stand test
Time Frame: Baseline to 10 weeks
Measure of lower extremity muscle power and a proxy measure of mobility
Baseline to 10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Multiple Sclerosis Hospitals

Collaborators

Tel Aviv University
University of Limerick
University of Cagliari
MS Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Telerehabilitation in PWMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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