Skip to main content
OpenTrials
Completed

NCT Number: NCT03655431

Home Exercise Telerehabiliation for MS

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington DC VAMC

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Multiple Sclerosis Walking Scale-12 (MSWS-12)

    Time frame: 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 outcomes

  1. Short Physical Performance Battery (SPPB)

    Time frame: 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.

  2. 25-Foot Walk Test (25FWT)

    Time frame: 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.

  3. Modified Fatigue Impact Scale (MFIS)

    Time frame: 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.

  4. Veteran Rand 12 Quality of Life Measure (VR-12)

    Time frame: 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.

Other outcomes

  1. Patient Travel

    Time frame: Start of participation

    Patient reported estimates of commute to medical facility.

Sponsors and collaborators

Lead sponsor

Shane.Chanpimol

Fed

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Aug 31, 2018
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.