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Upper Extremity Recovery Post Stroke Using Virtual Occupations

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SaeboVR
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring rehabilitation, upper extremity, virtual reality, SaeboVR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of ManitobaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SaeboVR

Arm Description

Use of the SaeboVR for task specific upper extremity training

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 20, 2019
Last Updated
April 3, 2019
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT03886480
Brief Title
Upper Extremity Recovery Post Stroke Using Virtual Occupations
Official Title
Investigating the Effects of Virtual Occupations on Upper Extremity Recovery Using the Saebo VR Rehabilitation System in Stroke Survivors: a Multiple Single-subject Design Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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: 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. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
rehabilitation, upper extremity, virtual reality, SaeboVR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SaeboVR
Arm Type
Experimental
Arm Description
Use of the SaeboVR for task specific upper extremity training
Intervention Type
Device
Intervention Name(s)
SaeboVR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure
Description
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.
Time Frame
Change from baseline perception of occupational performance to 4 weeks
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
Description
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.
Time Frame
Change from baseline upper extremity impairment to 4 weeks
Title
Arm Activity Measure
Description
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.
Time Frame
Change from baseline upper extremity function to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brenda Semenko, MSc
Phone
204-612-3182
Email
Brenda.Semenko@umanitoba.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda Semenko, MSc
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenda L Semenko, MSc
Phone
204-612-3182
Email
Brenda.Semenko@umanitoba.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27079654
Citation
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.
Results Reference
background
PubMed Identifier
29324411
Citation
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.
Results Reference
background
PubMed Identifier
25871604
Citation
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.
Results Reference
background
PubMed Identifier
29156493
Citation
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.
Results Reference
background

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Upper Extremity Recovery Post Stroke Using Virtual Occupations

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