Stroke Clinical Trial
— CITOfficial title:
Effect of Constraint-Induced Gaming Therapy in an Acute Care Setting
Verified date | April 2023 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Current protocols for therapy on a rehabilitation unit call for intensive rehabilitation composed of high intensity, long duration therapy. Evidence from brain healing and animal research, along with motor learning principles suggest that a treatment program composed of short duration therapy sessions distributed throughout the day may provide better rehabilitation outcomes for stroke patients. Such a program can be implemented using constraint-induced therapy in which the Veteran is provided with opportunities to use the affected limb while participating in a video game and completing complementary tasks in therapy. Additionally, rehabilitation outcomes may improve if Veterans are provided with regular opportunities to participate in gaming therapy at home after discharge from the hospital rather than having to travel to a clinic or receive limited or no follow-up in rural areas. This project will develop a therapeutic model that promotes use of the impaired arm and hand. Researchers often call this type of therapy "constraint induced therapy". In this study, participants focus on using the impaired limb rather than the unaffected limb. A small group of patients will participate in a question and answer session about preferences for activities which make up transfer tasks. Up to twenty-four (24) Veterans inpatient with hemiparesis due to stroke in the brain will be recruited from the Minneapolis VA Health Care System. Study participants will only be able to play the game using the impaired limb. Participants may also receive automated reminders to use the impaired arm throughout the day. Gaming will occur in patient room and during occupational therapy. Participants will have the option of being discharged with the gaming system for continued gameplay. Outcome measures will include motor function tests that evaluate upper extremity function.
Status | Completed |
Enrollment | 3 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 88 Years |
Eligibility | Inclusion Criteria: - Veteran between 18 and 88 years of age - Inpatient at the Minneapolis VAHCS - Willing and able to give Informed Consent or meets criteria for surrogate consent - Upper extremity hemiparesis resulting from stroke in the brain (including brainstem) or tumor resection at the discretion of the therapist - Lives within vicinity of the Minneapolis VA Exclusion Criteria: - Complete loss of arm function - No contact address or telephone - Active substance use disorder or major uncontrolled psychiatric disorder |
Country | Name | City | State |
---|---|---|---|
United States | Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183. — View Citation
Taub E, Wolf SL. Constraint Induced Movement Techniques To Facilitate Upper Extremity Use in Stroke Patients. Top Stroke Rehabil. 1997 Jan;3(4):38-61. doi: 10.1080/10749357.1997.11754128. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Action Research Arm Test (ARAT) | The ARAT is a 19-item observational method used to assess upper extremity function on four subscales (grasp, pinch, gross movement, and grip). ARAT scores range from 0-57 points, with 57 points indicating no upper extremity impairment, and 0 points indicating no upper extremity movement. | The ARAT was administered by OT at Day 0 (Enrollment), and discharge at 6 weeks post-enrollment for subject 1 and at 4 weeks post-enrollment for subject 2 | |
Primary | Motor Activity Log (MAL) Change (Discharge MAL - Enrollment MAL) | The Motor Activity Log (MAL) is a motivational tool to assist stroke survivors in identifying goal movements and tracking progress. The Quality of Movement (QOM) subscale has participants rate themselves on how well they perform various activities of daily living with their more affected arm on a 0-5 scale. Scores are averaged across items and range from 0-5, with higher scores indicating the participant's ability to use their affected arm just as well as before their stroke. | Performed at Day 0 (enrollment) and at discharge (at 6 weeks post-enrollment for subject 1 and 4 weeks post-enrollment for subject 2) | |
Secondary | Wolf Motor Function Test (WMFT) | The Wolf Motor Function Test (WMFT) is a time-limited method to evaluate upper extremity performance while providing insight into joint-specific and total limb movements. | The WMFT may be administered by OT at at Day 0 (Enrollment), discharge, and potentially at 3 months post-discharge. |
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