Physical Telerehabilitation in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT03230903
• Lead Sponsor: Columbia University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-27
• Primary Completion: 2020-09
• Study Completion: 2020-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cardiorespiratory fitness	Baseline up to 6 months	Cardiorespiratory fitness will be measured by oxygen consumption

Secondary Outcome Measures

Name	Time	Method
Exercise adherence	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.
MS Self-efficacy scale	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.
Center for Epidemiologic Studies Depression Scale (CES-D)	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)	Baseline up to 6 months	BBS is a clinical 14-item scale designed to measure balance
2-Minute Walk Test (2MWT)	Baseline up to 6 months	Total distance walked in meters will be recorded.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States