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Physical Telerehabilitation in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home telerehabilitation
Usual Care
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Telerehabilitation, Physical rehabilitation

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Home Telerehabilitation

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cardiorespiratory fitness
Cardiorespiratory fitness will be measured by oxygen consumption

Secondary Outcome Measures

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.
Exercise adherence
Exercise adherence will be measured by the number of sessions completed by the participant out of the number of exercise sessions prescribed.
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.
Berg Balance Scale (BBS)
BBS is a clinical 14-item scale designed to measure balance
2-Minute Walk Test (2MWT)
Total distance walked in meters will be recorded.

Full Information

First Posted
January 4, 2017
Last Updated
February 16, 2021
Sponsor
Columbia University
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03230903
Brief Title
Physical Telerehabilitation in Multiple Sclerosis
Official Title
Physical Telerehabilitation in Patients With Multiple Sclerosis With Significant Mobility Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Telerehabilitation, Physical rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home Telerehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Home telerehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Patients will receive a written individualized exercise plan during their baseline visit on top of their usual disease care.
Primary Outcome Measure Information:
Title
Cardiorespiratory fitness
Description
Cardiorespiratory fitness will be measured by oxygen consumption
Time Frame
Baseline up to 6 months
Secondary Outcome Measure Information:
Title
MS Self-efficacy scale
Description
MS Self-efficacy scale is a 14-point questionnaire designed to assess the psychological adjustment and quality-of-life of individuals with MS.
Time Frame
Baseline up to 6 months
Title
Exercise adherence
Description
Exercise adherence will be measured by the number of sessions completed by the participant out of the number of exercise sessions prescribed.
Time Frame
Baseline up to 6 months
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
The CES-D is a 20 point questionnaire based on self-reported frequency of symptoms related to depression during the past week.
Time Frame
Baseline up to 6 months
Title
Berg Balance Scale (BBS)
Description
BBS is a clinical 14-item scale designed to measure balance
Time Frame
Baseline up to 6 months
Title
2-Minute Walk Test (2MWT)
Description
Total distance walked in meters will be recorded.
Time Frame
Baseline up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Stein, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Physical Telerehabilitation in Multiple Sclerosis

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