Fast Muscle Activation and Stepping Training (FAST) Post-stroke (FAST)
Primary Purpose
Stroke, Hemiparesis
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Usual Care
FAST protocol
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Physical Therapy, Exercise therapy
Eligibility Criteria
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
Sites / Locations
- Lions Gate HospitalRecruiting
- Holy Family HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual care
FAST protocol
Arm Description
The usual care will consist of strength training, endurance, range of motion, patient education, weight shifting in standing and gait re-training.
The Fast muscle activation and stepping training will be the Experimental arm of this trial. This program will be exercises emphasizing speed of movement.
Outcomes
Primary Outcome Measures
Community Balance and Mobility Scale
Secondary Outcome Measures
Gait assessment
Self selected speed and changes in electromyography
Physiological balance assessment by internal and external perturbations
Electromyography and Center of pressure changes
Activities-specific Balance Confidence Scale
Community Balance and Mobility Scale
Full Information
NCT ID
NCT01573585
First Posted
April 5, 2012
Last Updated
June 27, 2016
Sponsor
University of British Columbia
Collaborators
Heart and Stroke Foundation of Canada
1. Study Identification
Unique Protocol Identification Number
NCT01573585
Brief Title
Fast Muscle Activation and Stepping Training (FAST) Post-stroke
Acronym
FAST
Official Title
Effectiveness of Fast Muscle Activation and Stepping Training (FAST) on Balance and Mobility Post-stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Heart and Stroke Foundation of Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
It is estimated that 75-80% of individuals who have had a stroke will survive the acute event and be left with residual disability. Regaining independence in standing and walking is of utmost importance for patients recovering from stroke. Walking balance requires muscles in the legs and trunk to contract quickly if people lose their balance. Physical therapy plays a key role in the rehabilitation of walking balance in individuals after stroke. Given that maintaining one's balance requires fast muscle activity, rehabilitation post-stroke should focus on speed of movement. Thus we are proposing to compare a program that emphasizes speed of movement, Fast muscle Activation and Stepping Training versus an active control (usual care).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
Physical Therapy, Exercise therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
The usual care will consist of strength training, endurance, range of motion, patient education, weight shifting in standing and gait re-training.
Arm Title
FAST protocol
Arm Type
Experimental
Arm Description
The Fast muscle activation and stepping training will be the Experimental arm of this trial. This program will be exercises emphasizing speed of movement.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
The Usual Care program will consist of 2 sessions a week for 45 minutes for a 6 week duration.
Intervention Type
Behavioral
Intervention Name(s)
FAST protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Community Balance and Mobility Scale
Time Frame
Pre treatment and Post treatment (6 weeks)
Secondary Outcome Measure Information:
Title
Gait assessment
Description
Self selected speed and changes in electromyography
Time Frame
Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)
Title
Physiological balance assessment by internal and external perturbations
Description
Electromyography and Center of pressure changes
Time Frame
Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)
Title
Activities-specific Balance Confidence Scale
Time Frame
Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)
Title
Community Balance and Mobility Scale
Time Frame
Post treatment and Retention (+1 month after treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
S. Jayne Garland, PT PhD
Phone
604-827-5372
Email
jayne.garland@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Jayne Garland, PT, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lions Gate Hospital
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 2L7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delores Langford, MSc, BScPt
Phone
604 984 5746
Email
delores.langford@vch.ca
Facility Name
Holy Family Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5P 3L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Shook, MRSc, PT
Phone
604-321-2661
Ext
22332
Email
rshook@providencehealth.bc.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25300433
Citation
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.
Results Reference
background
PubMed Identifier
32168159
Citation
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.
Results Reference
derived
Learn more about this trial
Fast Muscle Activation and Stepping Training (FAST) Post-stroke
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