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NCT Number: NCT03230903

Physical Telerehabilitation in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home telerehabilitation

Other

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.

Usual Care

Other

Patients will receive a written individualized exercise plan during their baseline visit on top of their usual disease care.

Primary outcomes

  1. Cardiorespiratory fitness

    Time frame: Baseline up to 6 months

    Cardiorespiratory fitness will be measured by oxygen consumption

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Physical Telerehabilitation in Patients With Multiple Sclerosis With Significant Mobility Impairment

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2017
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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