Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT02969967
Eligibility Criteria:
Inclusion Criteria:
* adults aged 18 or over who have had a first stroke within the past 6 months
* admitted to Riverview Health Centre (Winnipeg, Canada) for stroke rehabilitation and are being discharged to home locations within the city of Winnipeg
* fit with and started using a custom SaeboFlex orthosis as an inpatient at Riverview Health Centre after having met the active and passive movement criteria required to use the SaeboFlex orthosis
* referred to outpatient Occupational Therapy at the Health Sciences Centre (Winnipeg, Canada) for ongoing upper extremity rehabilitation using a SaeboFlex orthosis
* able to commit to the time requirements of the study
* have a premorbid fully functional upper extremity
* able to speak and understand English
* able to follow multistep commands and understand the purpose and required use of the orthosis
* able to stand for at least 10 minutes
* have 3 times per week access to a caregiver to assist with donning the orthosis at home if required
Exclusion Criteria:
* Chedoke McMaster Stroke Assessment, Impairment Inventory (Shoulder Pain section) score of 1-3
* score of 3 or more on the Modified Ashworth Scale for elbow, wrist or finger flexors
* swan neck deformities or contractures of the fingers or wrist of the paretic upper extremity
* history of skin breakdown on the paretic upper extremity or a score of less than 6 out of 12 on the Sensation Section of the Fugl-Meyer Upper Extremity Assessment
* significant cognitive impairment as determined by a score of 21 or less on the Montreal Cognitive Assessment
* able to fully extend fingers 10 times in a position of maximal shoulder flexion and elbow extension with a neutral wrist
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02969967
Study Brief:
Protocol Section:
NCT02969967