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Home Exercise Telerehabiliation for MS

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ClinicalTrials.gov Identifier: NCT03655431
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Shane.Chanpimol, Washington D.C. Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Telerehabilitation Other: Standard treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: An experimental and control group will be utilized. The experimental group will perform the telerehabilitation intervention and the control group will receive standard care.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telerehabilitation Using Kinect-based VR to Improve Mobility and Fatigue in Veterans With MS
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: Standard treatment
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 in-person appointments for treatment. Appointments 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 the control arm will receive standard home exercise program handouts and complete an exercise log to monitor exercise frequency. Exercises and progression will be administered and adjusted during in-person appointments.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Patient Travel [ Time Frame: Start of participation ]
    Patient reported estimates of commute to medical facility.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655431


Contacts
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Contact: Shane Chanpimol, DPT 202-745-8000 ext 55854 shane.chanpimol@va.gov

Locations
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United States, District of Columbia
Washington DC VAMC Recruiting
Washington, District of Columbia, United States, 20422
Contact: Shane Chanpimol, DPT    202-745-5854    shane.chanpimol@va.gov   
Contact: Mitchell Wallin, MD    202-745-8146    mitchell.walling@va.gov   
Principal Investigator: Mitchell Wallin, MD         
Sub-Investigator: Shane Chanpimol, DPT         
Sub-Investigator: Kim Benson, DPT         
Sub-Investigator: Heidi Maloni, NP         
Sponsors and Collaborators
Shane.Chanpimol
Investigators
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Principal Investigator: Mitchell Wallin, MD Washington DC VAMC

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Responsible Party: Shane.Chanpimol, Co-Investigator, Washington D.C. Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03655431     History of Changes
Other Study ID Numbers: 1846
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shane.Chanpimol, Washington D.C. Veterans Affairs Medical Center:
multiple sclerosis
rehabilitation
telerehabilitation
telehealth
veteran health
physical therapy

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases