Upper Extremity Recovery Post Stroke Using Virtual Occupations

NCT ID: NCT03886480

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-03

Study Completion Date

2019-05-31

Brief Summary

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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:

1. To explore the participants' level of performance and satisfaction with their performance in self-identified problem areas of daily functioning following a 4-week intervention using the SaeboVR rehabilitation system.
2. To evaluate the efficacy of an intervention protocol that emphasizes task-specific and goal-oriented virtual practice, reflecting the participants' self-identified goal priorities.

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SaeboVR

Use of the SaeboVR for task specific upper extremity training

Group Type EXPERIMENTAL

SaeboVR

Intervention Type 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.

Interventions

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SaeboVR

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* adults aged 18 or over with upper extremity deficits post stroke
* admitted to Riverview Health Centre (Winnipeg, Canada) for stroke rehabilitation and are being discharged to home locations within the city of Winnipeg
* referred to outpatient Occupational Therapy at the Health Sciences Centre (Winnipeg, Canada) for additional upper extremity retraining post-stroke
* have a premorbid fully functional upper extremity
* have anti-gravity strength of the affected elbow to at least 45 degrees of active flexion when in an upright seated position
* have anti-gravity strength of the affected shoulder to at least 30 degrees of active flexion and active abduction/adduction when in an upright seated position
* have active internal and external shoulder rotation of the affected shoulder to at least 15 degrees when in an upright seated position
* able to speak and understand English
* able to follow verbal instructions
* have normal visual acuity with corrective lenses
* have no noted visual neglect

Exclusion Criteria

* have a history of seizure
* have arthritis or pain restricting repetitive training of the affected upper extremity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Brenda Semenko

Sessional Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brenda Semenko, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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University of Manitoba

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Brenda Semenko, MSc

Role: CONTACT

204-612-3182

Facility Contacts

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Brenda L Semenko, MSc

Role: primary

204-612-3182

References

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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.

Reference Type BACKGROUND
PMID: 27079654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29324411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25871604 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29156493 (View on PubMed)

Other Identifiers

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H2019:010

Identifier Type: -

Identifier Source: org_study_id

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