CClinicalTrials.gg
Not yet recruitingNCT07310914PLATINUMSUpdated Dec 30, 2025

Implementation of an Advanced Telerehabilitation Solution for People With Multiple Sclerosis

A Phase 2 interventional study of Telerehabilitation and Paper-based exercise in Multiple Sclerosis, sponsored by Danish Multiple Sclerosis Hospitals. Not yet recruiting at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by Danish Multiple Sclerosis Hospitals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Sclerosis

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Keywords

  • Neurorehabilitation
  • Telerehabilitation
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 94 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

This is the only study on the registry with Danish Multiple Sclerosis Hospitals as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
94 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralTelerehabilitation

    Advanced telerehabilitation with a program made by specialized physiotherapists and delivered through the WizeCare system.

  • BehavioralPaper-based exercise

    Paper-based exercise instructions made by specialized physiotherapists.

06

What researchers measure

Primary outcomes

  1. 30 second sit to stand test

    Measure of lower extremity muscle power and a proxy measure of mobility

    Time frame: Baseline to 10 weeks

Secondary outcomes

  1. Short Physical Performance Battery

    Meaure of balance, walking function and lower extremity muscle strength

    Time frame: Baseline to 10 weeks

  2. Functional Reach Test

    A measure of stability

    Time frame: Baseline to 10 weeks

  3. Timed 25 feet foot walk test

    A measure of walking speed

    Time frame: Baseline to 10 weeks

  4. MiniBESTest

    A measure of balance

    Time frame: Baseline to 10 weeks

  5. Six minute walk test

    A measure of walking endurance

    Time frame: Baseline to 10 weeks

  6. Modified Fatigue Impact Scale

    Patient-reported measure of fatigue

    Time frame: Baseline

  7. 12 item Multiple Sclerosis Walking Scale

    Patient-reported outcome of walking function

    Time frame: Baseline to 10 weeks

  8. Multiple Sclerosis Impact Scale

    Patient-reported measure on the impact of multiple sclerosis

    Time frame: Baseline to 10 weeks

  9. EQ-5D-5L

    Patient-reported measure of quality of life

    Time frame: Baseline to 10 weeks

  10. State-Trait Anxiety Inventory

    Patient-reported measure of anxiety

    Time frame: Baseline to 10 weeks

  11. Quick Inventory of Depression Symptomology

    Patient-reported measure of depressive symptoms

    Time frame: Baseline to 10 weeks

  12. Client Services Receipt Inventory

    Patient-reported measure of used health services

    Time frame: Baseline to 10 weeks

  13. Digital Health Literacy Scale

    Patient-reported measure of digital health literacy

    Time frame: Baseline

  14. Telehealth Usability Questionnaire

    Patient-reported measure of telehealth usability

    Time frame: 10 weeks

  15. Semi-structed interview

    A semi-structured interview on the satisfaction with the telerehabilitation system

    Time frame: 10 weeks

07

Study locations

5 sites
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07310914
Lead sponsor
Danish Multiple Sclerosis Hospitals
Collaborators
MS Ireland, Tel Aviv University, University of Cagliari, University of Limerick
Responsible party
Lars Hvid (Senior Researcher, PHD, Danish Multiple Sclerosis Hospitals) — Principal investigator
First posted
Dec 30, 2025
Start date
Feb 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Dec 30, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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