- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01573585
Fast Muscle Activation and Stepping Training (FAST) Post-stroke (FAST)
Effectiveness of Fast Muscle Activation and Stepping Training (FAST) on Balance and Mobility Post-stroke
The purpose of this study is to determine whether FAST (Fast muscle Activation and Stepping Training) exercises will improve walking balance in individuals after stroke to a greater extent than usual care.
Hypothesis: The primary hypothesis is that improvements in walking balance will be larger following 12 sessions of FAST exercise retraining compared to usual care in persons in the sub-acute phase after stroke.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
British Columbia
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North Vancouver, British Columbia, Canada, V7L 2L7
- Lions Gate Hospital
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Vancouver, British Columbia, Canada, V5P 3L6
- Holy Family Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Study population: Subjects with a diagnosis of stroke
Inclusion Criteria:
- first stroke (<6 months ago)
- presence of hemiparesis in the lower extremity
- minimum Berg Balance Score (BBS) of 30/56
- cognitive ability to give informed consent
Exclusion Criteria:
- bilateral stroke, or a previous stroke in the other hemisphere
- severe co-morbidity that is likely to dominate the pattern of care
- co-existing peripheral neuropathies or disorders of the vestibular apparatus
- musculoskeletal problems
- global aphasia or receptive aphasia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Usual care
The usual care will consist of strength training, endurance, range of motion, patient education, weight shifting in standing and gait re-training.
|
The Usual Care program will consist of 2 sessions a week for 45 minutes for a 6 week duration.
|
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Experimental: FAST protocol
The Fast muscle activation and stepping training will be the Experimental arm of this trial.
This program will be exercises emphasizing speed of movement.
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The Fast muscle activation and Stepping Training (FAST protocol) will be exercises emphasizing speed, small squats and protective steps, that will be progressed.
This program will be 2 sessions a week for 45 minutes for 6 weeks in duration.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Community Balance and Mobility Scale
Time Frame: Pre treatment and Post treatment (6 weeks)
|
Pre treatment and Post treatment (6 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait assessment
Time Frame: Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)
|
Self selected speed and changes in electromyography
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Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)
|
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Physiological balance assessment by internal and external perturbations
Time Frame: Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)
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Electromyography and Center of pressure changes
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Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)
|
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Activities-specific Balance Confidence Scale
Time Frame: Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)
|
Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)
|
|
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Community Balance and Mobility Scale
Time Frame: Post treatment and Retention (+1 month after treatment)
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Post treatment and Retention (+1 month after treatment)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: S. Jayne Garland, PT, PhD, University of British Columbia
Publications and helpful links
General Publications
- Miller KJ, Hunt MA, Pollock CL, Bryant D, Garland SJ. Protocol for a randomized controlled clinical trial investigating the effectiveness of Fast muscle Activation and Stepping Training (FAST) for improving balance and mobility in sub-acute stroke. BMC Neurol. 2014 Oct 10;14:187. doi: 10.1186/s12883-014-0187-y.
- Peters S, Ivanova TD, Lakhani B, Boyd LA, Garland SJ. Neuroplasticity of Cortical Planning for Initiating Stepping Poststroke: A Case Series. J Neurol Phys Ther. 2020 Apr;44(2):164-172. doi: 10.1097/NPT.0000000000000311.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
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
- H12-00837
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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