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NCT Number: NCT07310914

Implementation of an Advanced Telerehabilitation Solution for People With Multiple Sclerosis

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Danish MS Hospitals, Haslev, Haslev, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Short Physical Performance Battery

    Time frame: Baseline to 10 weeks

    Meaure of balance, walking function and lower extremity muscle strength

  2. Functional Reach Test

    Time frame: Baseline to 10 weeks

    A measure of stability

  3. Timed 25 feet foot walk test

    Time frame: Baseline to 10 weeks

    A measure of walking speed

  4. MiniBESTest

    Time frame: Baseline to 10 weeks

    A measure of balance

  5. Six minute walk test

    Time frame: Baseline to 10 weeks

    A measure of walking endurance

  6. Modified Fatigue Impact Scale

    Time frame: Baseline

    Patient-reported measure of fatigue

  7. 12 item Multiple Sclerosis Walking Scale

    Time frame: Baseline to 10 weeks

    Patient-reported outcome of walking function

  8. Multiple Sclerosis Impact Scale

    Time frame: Baseline to 10 weeks

    Patient-reported measure on the impact of multiple sclerosis

  9. EQ-5D-5L

    Time frame: Baseline to 10 weeks

    Patient-reported measure of quality of life

  10. State-Trait Anxiety Inventory

    Time frame: Baseline to 10 weeks

    Patient-reported measure of anxiety

  11. Quick Inventory of Depression Symptomology

    Time frame: Baseline to 10 weeks

    Patient-reported measure of depressive symptoms

  12. Client Services Receipt Inventory

    Time frame: Baseline to 10 weeks

    Patient-reported measure of used health services

  13. Digital Health Literacy Scale

    Time frame: Baseline

    Patient-reported measure of digital health literacy

  14. Telehealth Usability Questionnaire

    Time frame: 10 weeks

    Patient-reported measure of telehealth usability

  15. Semi-structed interview

    Time frame: 10 weeks

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

Sponsors and collaborators

Lead sponsor

Danish Multiple Sclerosis Hospitals

Other

Collaborators

  • MS Ireland
  • Tel Aviv University
  • University of Cagliari
  • University of Limerick

Registry information

Acronym: PLATINUMS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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