NCT07310914

Brief 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.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for phase_2 multiple-sclerosis

Timeline
14mo left

Started Feb 2026

Shorter than P25 for phase_2 multiple-sclerosis

Geographic Reach
4 countries

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Feb 2026Jul 2027

First Submitted

Initial submission to the registry

December 16, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

December 16, 2025

Last Update Submit

December 16, 2025

Conditions

Multiple Sclerosis

Keywords

NeurorehabilitationTelerehabilitation

Outcome Measures

Primary Outcomes (1)

  • 30 second sit to stand test

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

    Baseline to 10 weeks

Secondary Outcomes (15)

  • Short Physical Performance Battery

    Baseline to 10 weeks

  • Functional Reach Test

    Baseline to 10 weeks

  • Timed 25 feet foot walk test

    Baseline to 10 weeks

  • MiniBESTest

    Baseline to 10 weeks

  • Six minute walk test

    Baseline to 10 weeks

  • +10 more secondary outcomes

Study Arms (2)

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

Paper-based instructions

ACTIVE COMPARATOR

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

TelerehabilitationBEHAVIORAL

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

Experimental
Paper-based exerciseBEHAVIORAL

Paper-based exercise instructions made by specialized physiotherapists.

Paper-based instructions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Danish MS Hospitals, Haslev

Haslev, 4690, Denmark

Location

The Danish MS Hospitals, Ry

Ry, 8660, Denmark

Location

MS Ireland

Dublin, Ireland

Location

Tel Aviv University

Tel Aviv, Israel

Location

University of Cagliari

Cagliari, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher, PHD

Study Record Dates

First Submitted

December 16, 2025

First Posted

December 30, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations

IT(1)IL(1)IE(1)DK(2)