StrokeNCT03886480
Upper Extremity Recovery Post Stroke Using Virtual Occupations
A study testing SaeboVR in people with Stroke, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- SaeboVR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 3 Apr 2019to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- have a history of seizure
- have arthritis or pain restricting repetitive training of the affected upper extremity
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Manitoba
Winnipeg, Manitoba
Brenda L Semenko, MSc, 204-612-3182, Brenda.Semenko@umanitoba.ca
About this study
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
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- SaeboVR
- Keywords
- rehabilitation, upper extremity, virtual reality, SaeboVR
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaeboVRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SaeboVR | Experimental | Use of the SaeboVR for task specific upper extremity training Receives: Device: SaeboVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline perception of occupational performance to 4 weeks
Secondary outcomes (2)
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.
Measured: Change from baseline upper extremity impairment to 4 weeks
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.
Measured: Change from baseline upper extremity function to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start3 Apr 2019
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brenda Semenko, University of Manitoba
- Investigators
- Brenda Semenko, MSc, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886480
- Sponsor's protocol ID
- H2019:010
- Status last verified
- Apr 2019
- First submitted
- 20 Mar 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27079654Adams 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.
PubMed 29324411Ellington 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.
PubMed 25871604Laver 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.
PubMed 29156493
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03886480
- Acronym / sponsor ID
- H2019:010
- Conditions
- Stroke
- Keywords
- rehabilitation, upper extremity, virtual reality, SaeboVR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SaeboVR | Experimental | Device: SaeboVRUse of the SaeboVR for task specific upper extremity training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (2 listed)
- have a history of seizure
- have arthritis or pain restricting repetitive training of the affected upper extremity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaeboVRUse 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. | Device | SaeboVR |
Primary outcome
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.
2 secondary outcomes
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
Time frame: Change from baseline upper extremity impairment to 4 weeks
Arm Activity Measure
Time frame: Change from baseline upper extremity function to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Background: PubMed 27079654Hebert 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.
- Background: PubMed 29324411Adams 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.
- Background: PubMed 25871604Ellington 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.
- Background: PubMed 29156493Laver 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenda Semenko, MSc principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SaeboVR in people with Stroke, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brenda Semenko, MSc (204-612-3182, Brenda.Semenko@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (time frame: Change from baseline perception of occupational performance to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03886480, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.