Physical Telerehabilitation in Multiple Sclerosis

Study Overview
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Brief Summary
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The study aims to evaluate the efficacy of the MS HAT (Multiple Sclerosis Home Automated Telemanagement) System as an adjunct to the current standard of medical care for patients with MS (PwMS). The individual patient with MS will be the unit of analysis. For each participant, the investigators will assess the effect of Home Automated Telemanagement (HAT) on functional outcomes, levels of disablement including impairment, activity and participation, socio-behavioral parameters, and satisfaction with medical care as described below.

Detailed Description
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People with multiple sclerosis may develop severe disability over the time. Physical therapy including regular exercise helps patients with severe disability to maintain muscle strength, reduce disease symptoms and improve quality of life. However physical therapy programs at clinical settings require constant travel which may limit access of patients with mobility disability to these services on continuous basis.Technology can allow patients with mobility disability exercise at home under supervision of their rehabilitation team. Currently it is unclear how effective this approach is. The study aims to demonstrate that the patients who were helped by the new technology to exercise at home will have better fitness, less symptoms and better quality of life. If so, other patients with significant mobility disability will be able to take advantage of this technology. This approach can be extended to people with different diseases causing mobility impairment and it can be used not only for physical but also for cognitive and occupational rehabilitation.

Official Title
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Physical Telerehabilitation in Patients With Multiple Sclerosis With Significant Mobility Impairment

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Home telerehabilitation
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >21 Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria EDSS range 5.0-8.0 Mini-Mental State Examination (MMSE) > 22 or presence of a caregiver to assist in daily exercise regimen Exclusion Criteria: Coronary artery disease Congestive Heart Failure Uncontrolled hypertension Epilepsy Pacemaker or implanted defibrillator Unstable fractures or other musculoskeletal diagnoses

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Telerehabilitation<br>The physical telerehabilitation group will receive an exercise plan, exercise equipment, a computer, and access to a daily individualized exercise plan. Participants in this group will follow the exercise plan that is sent to their computer via the telerehabilitation software. Participants will have interactions with a physical therapist and an exercise physiologist throughout training intervention. | Other: Home telerehabilitation<br>* Patients will receive an individualized exercise plan sent to a computer at their home. Patients will have daily access to a physical therapist and exercise physiologist.<br>|
| Sham Comparator: Usual Care<br>The usual care group will receive an individualized exercise program at baseline however participants will not receive the home telerehabilitation system or exercise equipment. Participants assigned to the usual care group will also not have access to the study physical therapist or exercise physiologist during the intervention. | Other: Usual Care<br>* Patients will receive a written individualized exercise plan during their baseline visit on top of their usual disease care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory fitness | Cardiorespiratory fitness will be measured by oxygen consumption | Baseline up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MS Self-efficacy scale | MS Self-efficacy scale is a 14-point questionnaire designed to assess the psychological adjustment and quality-of-life of individuals with MS. | Baseline up to 6 months | 
| Exercise adherence | Exercise adherence will be measured by the number of sessions completed by the participant out of the number of exercise sessions prescribed. | Baseline up to 6 months | 
| Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D is a 20 point questionnaire based on self-reported frequency of symptoms related to depression during the past week. | Baseline up to 6 months | 
| Berg Balance Scale (BBS) | BBS is a clinical 14-item scale designed to measure balance | Baseline up to 6 months | 
| 2-Minute Walk Test (2MWT) | Total distance walked in meters will be recorded. | Baseline up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Telerehabilitation, Physical rehabilitation