NCT03886480

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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

April 3, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

28 days

First QC Date

March 20, 2019

Last Update Submit

April 3, 2019

Conditions

Keywords

rehabilitation, upper extremity, virtual reality, SaeboVR

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Fugl-Meyer Assessment-Upper Extremity (FMA-UE)

    Change from baseline upper extremity impairment to 4 weeks

  • Arm Activity Measure

    Change from baseline upper extremity function to 4 weeks

Study Arms (1)

SaeboVR

EXPERIMENTAL

Use of the SaeboVR for task specific upper extremity training

Device: SaeboVR

Interventions

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.

SaeboVR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • have a history of seizure
  • have arthritis or pain restricting repetitive training of the affected upper extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, Canada

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27079654BACKGROUND
  • 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.

    PMID: 29324411BACKGROUND
  • 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.

    PMID: 25871604BACKGROUND
  • 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.

    PMID: 29156493BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Brenda Semenko, MSc

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenda Semenko, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sessional Instructor

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 22, 2019

Study Start

April 3, 2019

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

April 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations