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The purpose of this study is to explore the efficacy of the SaeboVR rehabilitation system for improving functional outcomes related to upper extremity motor recovery in stroke survivors.
The specific objectives are:
This study will employ a multiple single-subject pre-post experimental design, with multiple pre and post measures, to evaluate the potential efficacy of a virtual reality-based treatment using the SaeboVR rehabilitation system in stroke survivors. Comprehensive measurement during the baseline and post-treatment phases will be completed, with each individual to serve as their own control. Participants will make 3 separate visits to the laboratory (approximately 2 days apart) on the Bannatyne Campus at the University of Manitoba prior to the 4 week intervention and again after the intervention. The Arm Activity Measure (ArmA) and the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) will be used both pre and post intervention as well as the Canadian Occupational Performance Measure (COPM) to measure participants' performance on self-identified occupational performance issues and their level of satisfaction with their performance. Two participants will be recruited upon discharge from inpatient stroke rehabilitation at the Riverview Health Centre, Winnipeg, Manitoba, and upon entry into this study, will receive one-to-one treatment and supervision using the SaeboVR rehabilitation system for approximately 1 hour per session, 2 to 3 times per week for 4-weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SaeboVR | Experimental | Use of the SaeboVR for task specific upper extremity training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SaeboVR | Device | Use of the SaeboVR rehabilitation system for approximately 1 hour, 3 times per week for 4 weeks. Each intervention session will consist of the participant engaging in a series of virtual occupations involving their affected upper extremity and will include a 5 minute warm up activity followed by 3, 15 minute sessions of virtual occupation practice separated by 2, 5 minute breaks. The virtual occupations will include: grocery shopping, grocery storage, breakfast preparation, pet shopping, pet feeding, pet bathing, garden planting, garden harvesting, dinner preparation, closet organizing, and soup kitchen volunteering. |
| Measure | Description | Time Frame |
|---|---|---|
| Canadian Occupational Performance Measure | The Canadian Occupational Performance Measure (COPM) is a valid and responsive measure of occupational performance and has been widely used in stroke research. The COPM uses a semi-structured interview format where performance and satisfaction scores will be identified for the participants' self-identified occupational performance issues. | Change from baseline perception of occupational performance to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment-Upper Extremity (FMA-UE) | The Fugl-Meyer Assessment-Upper Extremity (FMA-UE) is a widely used measure of motor impairment post stroke and is comprised of 33 items related to upper extremity movement. The FMA-UE has excellent inter-rater and test-retest reliability as well as construct validity in persons with stroke. | Change from baseline upper extremity impairment to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brenda Semenko, MSc | Contact | 204-612-3182 | Brenda.Semenko@umanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Brenda Semenko, MSc | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba | Recruiting | Winnipeg | Manitoba | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27079654 | Background | Hebert D, Lindsay MP, McIntyre A, Kirton A, Rumney PG, Bagg S, Bayley M, Dowlatshahi D, Dukelow S, Garnhum M, Glasser E, Halabi ML, Kang E, MacKay-Lyons M, Martino R, Rochette A, Rowe S, Salbach N, Semenko B, Stack B, Swinton L, Weber V, Mayer M, Verrilli S, DeVeber G, Andersen J, Barlow K, Cassidy C, Dilenge ME, Fehlings D, Hung R, Iruthayarajah J, Lenz L, Majnemer A, Purtzki J, Rafay M, Sonnenberg LK, Townley A, Janzen S, Foley N, Teasell R. Canadian stroke best practice recommendations: Stroke rehabilitation practice guidelines, update 2015. Int J Stroke. 2016 Jun;11(4):459-84. doi: 10.1177/1747493016643553. Epub 2016 Apr 14. | |
| 29324411 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Arm Activity Measure | The Arm Activity Measure (ArmA) is a self-report tool designed for use with upper extremity spasticity management interventions. The ArmA was chosen because it provides a comprehensive assessment at the activity level of both active and passive upper extremity function; it is comprised of an 8 item passive function subscale and a 13 item active function subscale. Both subscales have been found to have high internal consistency and test-retest reliability. | Change from baseline upper extremity function to 4 weeks |
| Background |
| Adams RJ, Lichter MD, Ellington A, White M, Armstead K, Patrie JT, Diamond PT. Virtual Activities of Daily Living for Recovery of Upper Extremity Motor Function. IEEE Trans Neural Syst Rehabil Eng. 2018 Jan;26(1):252-260. doi: 10.1109/TNSRE.2017.2771272. |
| 25871604 | Background | Ellington A, Adams R, White M, Diamond P. Behavioral intention to use a virtual instrumental activities of daily living system among people with stroke. Am J Occup Ther. 2015 May-Jun;69(3):6903290030p1-8. doi: 10.5014/ajot.2015.014373. |
| 29156493 | Background | Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |