Implementation of an Advanced Telerehabilitation Solution for People With Multiple Sclerosis

NCT ID: NCT07310914

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Keywords

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Neurorehabilitation Telerehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Telerehabilitation

Intervention Type BEHAVIORAL

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

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

Group Type ACTIVE_COMPARATOR

Paper-based exercise

Intervention Type BEHAVIORAL

Paper-based exercise instructions made by specialized physiotherapists.

Interventions

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Telerehabilitation

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

Intervention Type BEHAVIORAL

Paper-based exercise

Paper-based exercise instructions made by specialized physiotherapists.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MS Ireland

UNKNOWN

Sponsor Role collaborator

Tel Aviv University

OTHER

Sponsor Role collaborator

University of Cagliari

OTHER

Sponsor Role collaborator

University of Limerick

OTHER

Sponsor Role collaborator

Danish Multiple Sclerosis Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Lars Hvid

Senior Researcher, PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Danish MS Hospitals, Haslev

Haslev, , Denmark

Site Status

The Danish MS Hospitals, Ry

Ry, , Denmark

Site Status

MS Ireland

Dublin, , Ireland

Site Status

Tel Aviv University

Tel Aviv, , Israel

Site Status

University of Cagliari

Cagliari, , Italy

Site Status

Countries

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Denmark Ireland Israel Italy

Facility Contacts

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Lars Hvid

Role: primary

Lars Hvid, Phd

Role: primary

Susan Coote

Role: primary

Alon Kalron

Role: primary

Massimiliano Pau

Role: primary

Other Identifiers

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Telerehabilitation in PWMS

Identifier Type: -

Identifier Source: org_study_id