Physical Telerehabilitation in Multiple Sclerosis

Physical Telerehabilitation in Patients With Multiple Sclerosis With Significant Mobility Impairment

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Home telerehabilitation; Other: Usual Care

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Telerehabilitation; Physical rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: AAAQ7693; MS150167 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED