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Home Exercise Telerehabiliation for MS

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telerehabilitation
Standard treatment
Sponsored by
Shane.Chanpimol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, rehabilitation, telerehabilitation, telehealth, veteran health, physical therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of MS based on the McDonald criteria
  • Expanded Disability Status Scale (EDSS) of 3.0 - 6.5
  • Cognitive ability (Montreal Cognitive Assessment score >23/30)
  • Physician clearance for exercise participation
  • Physical therapy referral

Exclusion Criteria:

  • MS-related exacerbation within last 3 months
  • Unstable cardiac or pulmonary disease
  • Active substance abuse
  • Uncontrolled seizures

Sites / Locations

  • Washington DC VAMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telerehabilitation

Arm Description

Physical therapists will develop an individualized program lasting 12 weeks depending on the needs of a given patient. Veterans will be seen 1 day/week via clinical video teleconferencing (CVT) for treatment. The rehabilitation protocol will last approximately 30 minutes with activities that are individualized to meet the participant's needs (range of motion, balance, strengthening, endurance, and functional activities). Patients assigned to telerehabilitation will utilize the VITAL rehab unit with Jintronix exercise package. Exercises, progression and rest periods will be administered and adjusted remotely by the physical therapist using a web-based clinical portal.

Outcomes

Primary Outcome Measures

Multiple Sclerosis Walking Scale-12 (MSWS-12)
This questionnaire has 12 items and measures self-reported walking ability in MS. The questions assess the limitations of a patient's walking due to MS during the past 2 weeks. Each item ranges from 1 to 5 and the higher the sum, the more severe the degree of limitation.

Secondary Outcome Measures

Short Physical Performance Battery (SPPB)
The test involves assessments of clinician rated strength tests of standing balance, timed 3 meter walk, and five chair rise repetitions. The rating scale starts at "0" indicating no performance or low performance ranging to as score of "4" indicating high performance. The rating scale ranges from 0 to 12.
25-Foot Walk Test (25FWT)
The patient is instructed to walk 25 feet as fast as safely possible. Scoring the 25FW is the average of 2 trials that are performed consecutively. If necessary, assistive devices are allowed to be used.
Modified Fatigue Impact Scale (MFIS)
This is a standard measure used to measure fatigue. The scale consists of 21 items, with 10 items related to mental fatigue, and 11 items relating to physical and social fatigue. The scoring ranges between 0 and 82, a high score reflecting greater impact.
Veteran Rand 12 Quality of Life Measure (VR-12)
This 12-item questionnaire has eight principal physical and mental health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning, and mental health. The 12 items is summarized into two sub-scores measuring physical health and mental health.

Full Information

First Posted
August 28, 2018
Last Updated
April 5, 2021
Sponsor
Shane.Chanpimol
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1. Study Identification

Unique Protocol Identification Number
NCT03655431
Brief Title
Home Exercise Telerehabiliation for MS
Official Title
Telerehabilitation Using Kinect-based VR to Improve Mobility and Fatigue in Veterans With MS
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shane.Chanpimol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to evaluate the effects of an individualized telerehabilitation program on mobility, fatigue, and quality of life for Veterans with MS. The secondary purpose was to assess adherence to exercise recommendations and overall satisfaction with the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, rehabilitation, telerehabilitation, telehealth, veteran health, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
An experimental and control group will be utilized. The experimental group will perform the telerehabilitation intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
Physical therapists will develop an individualized program lasting 12 weeks depending on the needs of a given patient. Veterans will be seen 1 day/week via clinical video teleconferencing (CVT) for treatment. The rehabilitation protocol will last approximately 30 minutes with activities that are individualized to meet the participant's needs (range of motion, balance, strengthening, endurance, and functional activities). Patients assigned to telerehabilitation will utilize the VITAL rehab unit with Jintronix exercise package. Exercises, progression and rest periods will be administered and adjusted remotely by the physical therapist using a web-based clinical portal.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
Participants complete a standard physical therapy evaluation in-person. They are then provided telerehabilitation equipment for the telerehabilitation intervention. This intervention utilizes an Xbox Kinect sensor and tablet-based exercise software called Jintronix. The Jintronix exercise library includes an array of exercise activity options for varying functional levels. Exercise activities could be completed in sitting or standing postures and includes activities which focused on active range of motion, strength, balance, or calisthenic movements. Each activity requires the participant to complete a goal-directed game or replicate movements of an on-screen avatar. The therapist will adjust and progress the home exercise program using information provided by the Jintronix and the participant's verbal reports during clinical video teleconferencing. At the end of the intervention, the therapist will complete in-person discharge assessments.
Intervention Type
Other
Intervention Name(s)
Standard treatment
Intervention Description
Participants complete standard in-person physical therapy evaluation, follow-up, and treatment. Therapeutic exercise and activities will be prescribed to participants to perform at home between standard follow-up treatment appointments. At the end of the intervention, the physical therapist will complete in-person discharge assessments.
Primary Outcome Measure Information:
Title
Multiple Sclerosis Walking Scale-12 (MSWS-12)
Description
This questionnaire has 12 items and measures self-reported walking ability in MS. The questions assess the limitations of a patient's walking due to MS during the past 2 weeks. Each item ranges from 1 to 5 and the higher the sum, the more severe the degree of limitation.
Time Frame
Change after 12-week intervention
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery (SPPB)
Description
The test involves assessments of clinician rated strength tests of standing balance, timed 3 meter walk, and five chair rise repetitions. The rating scale starts at "0" indicating no performance or low performance ranging to as score of "4" indicating high performance. The rating scale ranges from 0 to 12.
Time Frame
Change after 12-week intervention
Title
25-Foot Walk Test (25FWT)
Description
The patient is instructed to walk 25 feet as fast as safely possible. Scoring the 25FW is the average of 2 trials that are performed consecutively. If necessary, assistive devices are allowed to be used.
Time Frame
Change after 12-week intervention
Title
Modified Fatigue Impact Scale (MFIS)
Description
This is a standard measure used to measure fatigue. The scale consists of 21 items, with 10 items related to mental fatigue, and 11 items relating to physical and social fatigue. The scoring ranges between 0 and 82, a high score reflecting greater impact.
Time Frame
Change after 12-week intervention
Title
Veteran Rand 12 Quality of Life Measure (VR-12)
Description
This 12-item questionnaire has eight principal physical and mental health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning, and mental health. The 12 items is summarized into two sub-scores measuring physical health and mental health.
Time Frame
Change after 12-week intervention
Other Pre-specified Outcome Measures:
Title
Patient Travel
Description
Patient reported estimates of commute to medical facility.
Time Frame
Start of participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of MS based on the McDonald criteria Expanded Disability Status Scale (EDSS) of 3.0 - 6.5 Cognitive ability (Montreal Cognitive Assessment score >23/30) Physician clearance for exercise participation Physical therapy referral Exclusion Criteria: MS-related exacerbation within last 3 months Unstable cardiac or pulmonary disease Active substance abuse Uncontrolled seizures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Wallin, MD
Organizational Affiliation
Washington DC VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington DC VAMC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33014426
Citation
Chanpimol S, Benson K, Maloni H, Conroy S, Wallin M. Acceptability and outcomes of an individualized exergaming telePT program for veterans with multiple sclerosis: a pilot study. Arch Physiother. 2020 Oct 1;10:18. doi: 10.1186/s40945-020-00089-5. eCollection 2020.
Results Reference
derived
Links:
URL
https://archivesphysiotherapy.biomedcentral.com/articles/10.1186/s40945-020-00089-5
Description
Link to completed open-source publication.

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Home Exercise Telerehabiliation for MS

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