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Fast Muscle Activation and Stepping Training (FAST) Post-stroke (FAST)

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ClinicalTrials.gov Identifier: NCT01573585
Recruitment Status : Recruiting
First Posted : April 9, 2012
Last Update Posted : June 29, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Stroke Hemiparesis Behavioral: Usual Care Behavioral: FAST protocol

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Fast Muscle Activation and Stepping Training (FAST) on Balance and Mobility Post-stroke
Study Start Date : November 2012
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : June 2017
Arms and Interventions

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.
Behavioral: Usual Care
The Usual Care program will consist of 2 sessions a week for 45 minutes for a 6 week duration.
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.
Behavioral: FAST protocol
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.

Outcome Measures

Primary Outcome Measures :
  1. Community Balance and Mobility Scale [ Time Frame: Pre treatment and Post treatment (6 weeks) ]

Secondary Outcome Measures :
  1. Gait assessment [ Time Frame: Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment) ]
    Self selected speed and changes in electromyography

  2. Physiological balance assessment by internal and external perturbations [ Time Frame: Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment) ]
    Electromyography and Center of pressure changes

  3. Activities-specific Balance Confidence Scale [ Time Frame: Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment) ]
  4. Community Balance and Mobility Scale [ Time Frame: Post treatment and Retention (+1 month after treatment) ]

Eligibility Criteria

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573585

Contact: S. Jayne Garland, PT PhD 604-827-5372 jayne.garland@ubc.ca

Canada, British Columbia
Lions Gate Hospital Recruiting
North Vancouver, British Columbia, Canada, V7L 2L7
Contact: Delores Langford, MSc, BScPt    604 984 5746    delores.langford@vch.ca   
Holy Family Hospital Recruiting
Vancouver, British Columbia, Canada, V5P 3L6
Contact: Rebecca Shook, MRSc, PT    604-321-2661 ext 22332    rshook@providencehealth.bc.ca   
Sponsors and Collaborators
University of British Columbia
Heart and Stroke Foundation of Canada
Principal Investigator: S. Jayne Garland, PT, PhD University of British Columbia
More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01573585     History of Changes
Other Study ID Numbers: H12-00837
First Posted: April 9, 2012    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of British Columbia:
Physical Therapy
Exercise therapy

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms