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Upper Extremity Recovery Post Stroke Using Virtual Occupations

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ClinicalTrials.gov Identifier: NCT03886480
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Brenda Semenko, University of Manitoba

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:

  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.

Condition or disease Intervention/treatment Phase
Stroke Device: SaeboVR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 3, 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: SaeboVR
Use of the SaeboVR for task specific upper extremity training
Device: 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.




Primary Outcome Measures :
  1. Canadian Occupational Performance Measure [ Time Frame: Change from baseline perception of occupational performance to 4 weeks ]
    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 :
  1. Fugl-Meyer Assessment-Upper Extremity (FMA-UE) [ Time Frame: Change from baseline upper extremity impairment to 4 weeks ]
    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.

  2. Arm Activity Measure [ Time Frame: Change from baseline upper extremity function to 4 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886480


Contacts
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Contact: Brenda Semenko, MSc 204-612-3182 Brenda.Semenko@umanitoba.ca

Locations
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Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada
Contact: Brenda L Semenko, MSc    204-612-3182    Brenda.Semenko@umanitoba.ca   
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Brenda Semenko, MSc University of Manitoba

Publications:
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Responsible Party: Brenda Semenko, Sessional Instructor, University of Manitoba
ClinicalTrials.gov Identifier: NCT03886480     History of Changes
Other Study ID Numbers: H2019:010
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brenda Semenko, University of Manitoba:
rehabilitation, upper extremity, virtual reality, SaeboVR

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases