- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00197509
Sit-to-Stand Training for Survivors of Stroke in a Long-Term Care Setting
Task Specific Training for Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The implementation of a sit-to-stand protocol and extra practice has been previously validated in a rehabilitation setting, where 68% of survivors of stroke who received the training, learned to stand safely and independently from a 16" surface (the height of a regular toilet). Our findings have been supported by other research that have shown that rising from sitting is a maneuver that has been advocated for strengthening the lower extremities of elderly individuals and patients with specific disorders such as stroke. During the acute care and rehabilitation phases, considerable effort is spent to maximize a person's functional abilities following a stroke; however, continued strengthening and activity appears to stop once an individual is admitted to a LTC facility.
The main purpose of this randomized controlled trial is to examine the efficacy of implementing the Sit-to-Stand (STS) protocol with or without extra sit-to-stand practice for survivors of stroke residing in Long-Term Care (LTC) facilities on (1) their ability to learn how to stand safely and independently from a 16" surface; (2) the number of staff injuries; (3) the number of residents' falls; (4) the quality of life of the residents and staff; and (5) the translation and maintenance of knowledge of the STS protocol by staff into their daily routines.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- Hamilton Health Sciences, Chedoke Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of cerebrovascular accident
- Reside in Long-Term Care Facility
- Have physician approval to participate in the study
- Are unable to stand up independently from a 16" surface without using their hands
- Have given informed consent
Exclusion Criteria:
- Expect to be leaving the facility in less than 24 weeks
- Have a terminal illness
- Have a total hip replacement or other orthopedic complication that prevents them from being able to safely use protocol
- Have pain that prevents their participation
- Are at higher risk for falling (i.e. blood pressure disorder/postural hypotension, vestibular disorder)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Ability to independently perform Sit-To-Stand at 12 weeks and 24 weeks
|
Score on quality of life measure (COOP) at 12 and 24 weeks
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Score on stroke assessment (CMSA) at 12 and 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
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Number of resident falls at 12 and 24 weeks
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Number of staff injuries at 12 and 24 weeks
|
Knowledge of staff on STS protocol immediately post-training, 12 and 24 weeks
|
Score on quality of life measure (SF-20) at 12 and 24 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Susan R Barreca, PT, BA, Hamilton Health Sciences Corporation
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-359
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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