Physical Telerehabilitation in Multiple Sclerosis

NCT03230903 | Completed DMC

• 2 other identifiers: AAAQ7693MS150167
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Telerehabilitation; Physical rehabilitation

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory fitness

  Cardiorespiratory fitness will be measured by oxygen consumption

  Baseline up to 6 months

Secondary Outcomes (5)

• MS Self-efficacy scale

  Baseline up to 6 months

• Exercise adherence

  Baseline up to 6 months

• Center for Epidemiologic Studies Depression Scale (CES-D)

  Baseline up to 6 months

• Berg Balance Scale (BBS)

  Baseline up to 6 months

• 2-Minute Walk Test (2MWT)

  Baseline up to 6 months

Study Arms (2)

Home Telerehabilitation

EXPERIMENTAL

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

Usual Care

SHAM COMPARATOR

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

Interventions

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.

Home Telerehabilitation

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Coronary artery disease
• Congestive Heart Failure
• Uncontrolled hypertension
• Epilepsy
• Pacemaker or implanted defibrillator
• Unstable fractures or other musculoskeletal diagnoses

Sponsors & Collaborators

• Columbia University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Joel Stein, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Simon Baruch Professor of Physical Medicine & Rehabilitation

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: July 27, 2017
• Study Start: October 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

US (1)