Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-03-11 @ 1:30 PM
Study NCT ID:
NCT02969967
Status:
COMPLETED
Last Update Posted:
2017-12-02
First Post:
2016-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Dynamic Wrist-hand Orthosis in Early Outpatient Rehabilitation of the Upper Extremity Post Stroke
Sponsor:
University of Manitoba
Organization:
Study Overview
Official Title:
Effectiveness of a Dynamic Wrist-hand Orthosis in Early Outpatient Rehabilitation of the Upper Extremity Post Stroke: a Multiple Single Subject Design Evaluation
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity recovery for people in the early phases of rehabilitation post stroke. The objectives of the study are:
1. to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity function, strength, movement, spasticity and self-perceived occupational performance, in addition to conventional therapy, with continued use immediately after discharge from inpatient stroke rehabilitation and while waiting for outpatient occupational therapy services
2. to explore the relationship between the participants' level of self-efficacy and use of the SaeboFlex orthosis in the home environment
3. to explore the participants' experience of use of the SaeboFlex orthosis in the home environment.
1. to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity function, strength, movement, spasticity and self-perceived occupational performance, in addition to conventional therapy, with continued use immediately after discharge from inpatient stroke rehabilitation and while waiting for outpatient occupational therapy services
2. to explore the relationship between the participants' level of self-efficacy and use of the SaeboFlex orthosis in the home environment
3. to explore the participants' experience of use of the SaeboFlex orthosis in the home environment.
Detailed Description:
Although intensive and repetitive use of the paretic upper extremity has been shown to improve upper extremity outcomes post stroke, few therapeutic approaches allow those with moderate to severe upper extremity impairment to independently participate in repetitive grasp and release activities. The SaeboFlex orthosis is a dynamic wrist-hand orthosis that assists with finger and thumb extension after functional grasping with the paretic hand and therefore may allow those with more affected upper extremities post stroke to participate in repetitive grasp and release activities that they otherwise would be unable to do. More research is required on the effectiveness of this orthosis in improving upper extremity recovery post stroke especially when used at home as a continuation of therapy received during inpatient rehabilitation. It has been suggested that guided home rehabilitation programs can improve the ability of stroke survivors to be more independent in their activities of daily living. This study is a mixed methods study combining a quantitative single subject ABA design and qualitative post study individual interviews to first capture quantitative information on the effectiveness of the SaeboFlex intervention and then qualitative information that will build on and further explain the quantitative data. Three participants who are using a SaeboFlex orthosis as part of their upper extremity rehabilitation program will be recruited from an inpatient stroke rehabilitation unit as they are being discharged from inpatient rehabilitation and will be seen by the principal investigator in their homes for 1 hour 3 times a week for 2 weeks and then once a week for 6 weeks while they are on the waiting list for outpatient occupational therapy services. The intervention will follow a set protocol of grasp-release activities using the SaeboFlex orthosis for 50 minutes at least 3 times per week, followed by 10 minutes of grasp-release activities without the orthosis, both of which will be graded to provide optimal upper extremity challenge throughout the intervention period. Repeated baseline assessments will be completed by a trained research assistant, in the participants' homes, within one week of discharge from inpatient stroke rehabilitation and will be repeated after 4 and 8 weeks of intervention, followed by individual interviews in the participants' homes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: