Home Exercise Telerehabiliation for MS

NCT ID: NCT03655431

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2021-01-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telerehabilitation

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.

Group Type: EXPERIMENTAL

Telerehabilitation

Intervention Type: 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.

Standard treatment

Intervention Type: 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.

Interventions

Telerehabilitation

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

Standard treatment

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shane.Chanpimol

FED

Sponsor Role: lead

Responsible Party

Shane.Chanpimol

Co-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mitchell Wallin, MD

Role: PRINCIPAL_INVESTIGATOR

Washington DC VAMC

Locations

Washington DC VAMC

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33014426 (View on PubMed)

Related Links

https://archivesphysiotherapy.biomedcentral.com/articles/10.1186/s40945-020-00089-5

Link to completed open-source publication.

Other Identifiers

1846

Identifier Type: -

Identifier Source: org_study_id