Home Exercise Telerehabiliation for MS

NCT03655431 | Completed

• 1 other identifier: 1846
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; rehabilitation; telerehabilitation; telehealth; veteran health; physical therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Change after 12-week intervention

Secondary Outcomes (4)

• Short Physical Performance Battery (SPPB)

  Change after 12-week intervention

• 25-Foot Walk Test (25FWT)

  Change after 12-week intervention

• Modified Fatigue Impact Scale (MFIS)

  Change after 12-week intervention

• Veteran Rand 12 Quality of Life Measure (VR-12)

  Change after 12-week intervention

Other Outcomes (1)

• Patient Travel

  Start of participation

Study Arms (1)

Telerehabilitation

EXPERIMENTAL

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.

Other: Telerehabilitation; Other: Standard treatment

Interventions

Telerehabilitation OTHER

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.

Telerehabilitation

Standard treatment OTHER

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.

Telerehabilitation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shane.Chanpimol: lead

Study Sites (1)

Washington DC VAMC

Washington D.C., District of Columbia, 20422, United States

Location

Related Publications (1)

• 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.

  PMID: 33014426 DERIVED

Related Links

• Link to completed open-source publication.

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Mitchell Wallin, MD

  Washington DC VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

Model Details: An experimental and control group will be utilized. The experimental group will perform the telerehabilitation intervention.

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start: October 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: January 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)