Physical Telerehabilitation in Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT03230903|
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : February 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Other: Home telerehabilitation Other: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Physical Telerehabilitation in Patients With Multiple Sclerosis With Significant Mobility Impairment|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||September 2020|
|Actual Study Completion Date :||September 2020|
Experimental: Home Telerehabilitation
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
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.
Sham Comparator: Usual Care
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
Patients will receive a written individualized exercise plan during their baseline visit on top of their usual disease care.
- Cardiorespiratory fitness [ Time Frame: Baseline up to 6 months ]Cardiorespiratory fitness will be measured by oxygen consumption
- MS Self-efficacy scale [ Time Frame: Baseline up to 6 months ]MS Self-efficacy scale is a 14-point questionnaire designed to assess the psychological adjustment and quality-of-life of individuals with MS.
- Exercise adherence [ Time Frame: Baseline up to 6 months ]Exercise adherence will be measured by the number of sessions completed by the participant out of the number of exercise sessions prescribed.
- Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline up to 6 months ]The CES-D is a 20 point questionnaire based on self-reported frequency of symptoms related to depression during the past week.
- Berg Balance Scale (BBS) [ Time Frame: Baseline up to 6 months ]BBS is a clinical 14-item scale designed to measure balance
- 2-Minute Walk Test (2MWT) [ Time Frame: Baseline up to 6 months ]Total distance walked in meters will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230903
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Joel Stein, MD||Columbia University|