Stroke Clinical Trial
Official title:
Determining Optimal Post-Stroke Exercise (DOSE)
NCT number | NCT01915368 |
Other study ID # | H13-01933 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2013 |
Est. completion date | December 2019 |
Verified date | December 2019 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute stroke rehabilitation.
Status | Completed |
Enrollment | 75 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - Have been admitted to a hospital unit for stroke rehabilitation - Within 10 weeks post-stroke - 19 years or older - Are experiencing difficulty walking Exclusion Criteria: - Requires greater than one person assist for transfer or ambulation - Have uncontrolled medical condition or another serious medication condition in addition to stroke - Unable to understand or follow directions |
Country | Name | City | State |
---|---|---|---|
Canada | Fanning Centre | Calgary | Alberta |
Canada | Foothills Medical Centre | Calgary | Alberta |
Canada | Laurel Place | Surrey | British Columbia |
Canada | Surrey Memorial Hospital | Surrey | British Columbia |
Canada | Toronto Rehabilitation Institute | Toronto | Ontario |
Canada | GF Strong Rehab Centre | Vancouver | British Columbia |
Canada | Holy Family Hospital | Vancouver | British Columbia |
Canada | Riverview Health Centre | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ambulatory function measured by the Six Minute Walk Test | Rehabilitation discharge (average 4-5 weeks post admission) | ||
Secondary | Ambulatory Function from the Six Minute Walk Test | 6 and 12 months post-stroke | ||
Secondary | Ambulatory function from the 5 Meter Walk Test | Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke | ||
Secondary | Balance function from the Berg Balance Scale | Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke | ||
Secondary | Ambulatory function from the Functional Ambulation Classification | Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke | ||
Secondary | Quality of life measured with EuroQol | Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke | ||
Secondary | Cognition measured by the Montreal Cognitive Assessment | Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke | ||
Secondary | Cognition measured by the Digit Symbols Substitution Test | Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke | ||
Secondary | Cognition measured by the Trail Making Test | Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke | ||
Secondary | Depression measured by Patient Health Questionnaire-9 | Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke | ||
Secondary | Heart rate measured during the intervention sessions | From 10 intervention sessions within the 4-week intervention | ||
Secondary | Step count measured during the intervention sessions | From 10 intervention sessions within the 4-week intervention |
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