Multiple Sclerosis Clinical Trial
Official title:
Physical Telerehabilitation in Patients With Multiple Sclerosis With Significant Mobility Impairment
Verified date | February 2021 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiorespiratory fitness | Cardiorespiratory fitness will be measured by oxygen consumption | Baseline up to 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Berg Balance Scale (BBS) | BBS is a clinical 14-item scale designed to measure balance | Baseline up to 6 months | |
Secondary | 2-Minute Walk Test (2MWT) | Total distance walked in meters will be recorded. | Baseline up to 6 months |
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