Home Exercise Telerehabiliation for MS

Multiple Sclerosis Clinical Trial

Official title:

Telerehabilitation Using Kinect-based VR to Improve Mobility and Fatigue in Veterans With MS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03655431
• Other study ID #: 1846
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: January 1, 2021

Study information

• Verified date: April 2021
• Source: Washington D.C. Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 1, 2021
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Washington DC VAMC	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Shane.Chanpimol

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Travel	Patient reported estimates of commute to medical facility.	Start of participation
Primary	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	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.	Change after 12-week intervention
Secondary	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.	Change after 12-week intervention
Secondary	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.	Change after 12-week intervention
Secondary	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.	Change after 12-week intervention

External Links

•   Link to completed open-source publication.