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

Sponsor
University of British Columbia (Other)
Overall Status
Unknown status
CT.gov ID
NCT01573585
Collaborator
Heart and Stroke Foundation of Canada (Other)
60
2
2
55
30
0.5

Study Details

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 Phase
  • Behavioral: Usual Care
  • Behavioral: FAST protocol
N/A

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
Anticipated 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 :
Nov 1, 2012
Anticipated Primary Completion Date :
Mar 1, 2017
Anticipated Study Completion Date :
Jun 1, 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 [Pre treatment and Post treatment (6 weeks)]

Secondary Outcome Measures

  1. Gait assessment [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 [Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)]

    Electromyography and Center of pressure changes

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

  4. Community Balance and Mobility Scale [Post treatment and Retention (+1 month after treatment)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
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

Locations

Site City State Country Postal Code
1 Lions Gate Hospital North Vancouver British Columbia Canada V7L 2L7
2 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01573585
Other Study ID Numbers:
  • H12-00837
First Posted:
Apr 9, 2012
Last Update Posted:
Jun 29, 2016
Last Verified:
Jun 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University of British Columbia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2016