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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
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Joel Stein, MD, 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Home telerehabilitation Other: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Cardiorespiratory fitness [ Time Frame: Baseline up to 6 months ]
    Cardiorespiratory fitness will be measured by oxygen consumption


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Berg Balance Scale (BBS) [ Time Frame: Baseline up to 6 months ]
    BBS is a clinical 14-item scale designed to measure balance

  5. 2-Minute Walk Test (2MWT) [ Time Frame: Baseline up to 6 months ]
    Total distance walked in meters will be recorded.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
United States Department of Defense
Investigators
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Principal Investigator: Joel Stein, MD Columbia University
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Responsible Party: Joel Stein, MD, Simon Baruch Professor of Physical Medicine & Rehabilitation, Columbia University
ClinicalTrials.gov Identifier: NCT03230903    
Other Study ID Numbers: AAAQ7693
MS150167 ( Other Grant/Funding Number: Department of Defense )
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Joel Stein, MD, Columbia University:
Multiple Sclerosis
Telerehabilitation
Physical rehabilitation
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases