Multiple SclerosisNCT03655431
Home Exercise Telerehabiliation for MS
A study testing Telerehabilitation and Standard treatment in people with Multiple Sclerosis, run by Shane.Chanpimol at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Telerehabilitation and Standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- MS-related exacerbation within last 3 months
- Unstable cardiac or pulmonary disease
- Active substance abuse
- Uncontrolled seizures
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington DC VAMC
Washington D.C., District of Columbia, 20422
About this study
Official title: Telerehabilitation Using Kinect-based VR to Improve Mobility and Fatigue in Veterans With 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Telerehabilitation, Standard treatment
- Keywords
- multiple sclerosis, rehabilitation, telerehabilitation, telehealth, veteran health, physical therapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
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 treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telerehabilitation; Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change after 12-week intervention
Secondary outcomes (4)
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.
Measured: Change after 12-week intervention
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.
Measured: Change after 12-week intervention
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.
Measured: Change after 12-week intervention
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.
Measured: Change after 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Oct 2016
- Primary completion1 Oct 2019
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An experimental and control group will be utilized. The experimental group will perform the telerehabilitation intervention.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shane.Chanpimol
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Shane.Chanpimol, Washington D.C. Veterans Affairs Medical Center
- Investigators
- Mitchell Wallin, MD, Principal investigator, Washington DC VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655431
- Sponsor's protocol ID
- 1846
- Status last verified
- Apr 2021
- First submitted
- 28 Aug 2018
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33014426
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation Using Kinect-based VR to Improve Mobility and Fatigue in Veterans With MS
- ClinicalTrials.gov ID
- NCT03655431
- Acronym / sponsor ID
- 1846
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, rehabilitation, telerehabilitation, telehealth, veteran health, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shane.ChanpimolUS federal agency
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An experimental and control group will be utilized. The experimental group will perform the telerehabilitation intervention.
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: Telerehabilitation, Other: Standard treatmentPhysical 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- MS-related exacerbation within last 3 months
- Unstable cardiac or pulmonary disease
- Active substance abuse
- Uncontrolled seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationParticipants 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. | Other | Telerehabilitation |
| Standard treatmentParticipants 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. | Other | Telerehabilitation |
Primary outcome
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.
4 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: Change after 12-week intervention
25-Foot Walk Test (25FWT)
Time frame: Change after 12-week intervention
Modified Fatigue Impact Scale (MFIS)
Time frame: Change after 12-week intervention
Veteran Rand 12 Quality of Life Measure (VR-12)
Time frame: Change after 12-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Derived from this study: PubMed 33014426Chanpimol 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.
- Link to completed open-source publication.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Wallin, MD principal investigator
Washington DC VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and Standard treatment in people with Multiple Sclerosis, run by Shane.Chanpimol at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Sclerosis Walking Scale-12 (MSWS-12) (time frame: Change after 12-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03655431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.