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

This study is not yet open for participant recruitment.
Verified April 2012 by University of British Columbia
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01573585
First received: April 5, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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 Intervention
Stroke
Hemiparesis
 Behavioral: Usual Care
Behavioral: FAST protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Fast Muscle Activation and Stepping Training (FAST) on Balance and Mobility Post-stroke

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Community Balance and Mobility Scale [ Time Frame: Pre treatment and Post treatment (6 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gait assessment [ Time Frame: Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment) ] [ Designated as safety issue: No ]
    Self selected speed and changes in electromyography

  • Physiological balance assessment by internal and external perturbations [ Time Frame: Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment) ] [ Designated as safety issue: No ]
    Electromyography and Center of pressure changes

  • Activities-specific Balance Confidence Scale [ Time Frame: Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment) ] [ Designated as safety issue: No ]
  • Community Balance and Mobility Scale [ Time Frame: Post treatment and Retention (+1 month after treatment) ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573585

Locations
Canada, British Columbia
Lions Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2L7
Holy Family Hospital
Vancouver, British Columbia, Canada, V5P 3L6
Sponsors and Collaborators
University of British Columbia
Heart and Stroke Foundation of Canada
Investigators
Principal Investigator: S. Jayne Garland, PT, PhD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01573585     History of Changes
Other Study ID Numbers: 00070112
Study First Received: April 5, 2012
Last Updated: April 5, 2012
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Paresis
Stroke
Cerebral Infarction
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 16, 2013