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

Stroke Clinical Trial

— FAST  

Official title:

Effectiveness of Fast Muscle Activation and Stepping Training (FAST) on Balance and Mobility Post-stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01573585
• Other study ID #: H12-00837
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2012
• Last updated: June 27, 2016
• Start date: November 2012
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: University of British Columbia
• Contact: S. Jayne Garland, PT PhD
• Phone: 604-827-5372
• Email: jayne.garland[@]ubc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiparesis
• Stroke

Intervention

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

Locations

Country	Name	City	State
Canada	Lions Gate Hospital	North Vancouver	British Columbia
Canada	Holy Family Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Community Balance and Mobility Scale		Pre treatment and Post treatment (6 weeks)	No
Secondary	Gait assessment	Self selected speed and changes in electromyography	Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)	No
Secondary	Physiological balance assessment by internal and external perturbations	Electromyography and Center of pressure changes	Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)	No
Secondary	Activities-specific Balance Confidence Scale		Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)	No
Secondary	Community Balance and Mobility Scale		Post treatment and Retention (+1 month after treatment)	No

External Links

•   Published study protocol