Home Exercise Telerehabiliation for MS

Not Applicable

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT03655431
• Lead Sponsor: Shane.Chanpimol

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Primary Completion: 2019-10-01
• Study Completion: 2021-01-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-05
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Multiple Sclerosis Walking Scale-12 (MSWS-12)	Change after 12-week intervention	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

Name	Time	Method
Short Physical Performance Battery (SPPB)	Change after 12-week intervention	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)	Change after 12-week intervention	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.
Veteran Rand 12 Quality of Life Measure (VR-12)	Change after 12-week intervention	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.
Modified Fatigue Impact Scale (MFIS)	Change after 12-week intervention	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.

Trial Locations

Locations (1)

Washington DC VAMC; 🇺🇸 Washington, District of Columbia, United States