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Not yet recruiting NCT07310914

Implementation of an Advanced Telerehabilitation Solution for People With Multiple Sclerosis

Phase II Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Telerehabilitation, Paper-based exercise.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark, Ireland, Israel, Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Telerehabilitation
    Advanced telerehabilitation with a program made by specialized physiotherapists and delivered through the WizeCare system.
  • Behavioral Paper-based exercise
    Paper-based exercise instructions made by specialized physiotherapists.

Primary outcome measures

  • 30 second sit to stand test [Time frame: Baseline to 10 weeks]
Secondary outcome measures (12)
  • Short Physical Performance Battery [Time frame: Baseline to 10 weeks]
  • Functional Reach Test [Time frame: Baseline to 10 weeks]
  • Timed 25 feet foot walk test [Time frame: Baseline to 10 weeks]
  • MiniBESTest [Time frame: Baseline to 10 weeks]
  • Six minute walk test [Time frame: Baseline to 10 weeks]
  • Modified Fatigue Impact Scale [Time frame: Baseline]
  • 12 item Multiple Sclerosis Walking Scale [Time frame: Baseline to 10 weeks]
  • Multiple Sclerosis Impact Scale [Time frame: Baseline to 10 weeks]
  • EQ-5D-5L [Time frame: Baseline to 10 weeks]
  • State-Trait Anxiety Inventory [Time frame: Baseline to 10 weeks]
  • Quick Inventory of Depression Symptomology [Time frame: Baseline to 10 weeks]
  • Client Services Receipt Inventory [Time frame: Baseline to 10 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 2 centers
  • The Danish MS Hospitals, Haslev — Haslev
  • The Danish MS Hospitals, Ry — Ry
Ireland · 1 center
  • MS Ireland — Dublin
Israel · 1 center
  • Tel Aviv University — Tel Aviv
Italy · 1 center
  • University of Cagliari — Cagliari

Identifiers

NCT: NCT07310914 · Telerehabilitation in PWMS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗