NCT01573585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

May 1, 2026

Status Verified

June 1, 2016

Enrollment Period

4.4 years

First QC Date

April 5, 2012

Last Update Submit

April 27, 2026

Conditions

StrokeHemiparesis

Keywords

Physical TherapyExercise therapy

Outcome Measures

Primary Outcomes (1)

  • Community Balance and Mobility Scale

    Pre treatment and Post treatment (6 weeks)

Secondary Outcomes (4)

  • Gait assessment

    Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)

  • Physiological balance assessment by internal and external perturbations

    Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)

  • Activities-specific Balance Confidence Scale

    Pre treatment, Post treatment (6 weeks) and Retention (+1 month after treatment)

  • Community Balance and Mobility Scale

    Post treatment and Retention (+1 month after treatment)

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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

FAST protocol

EXPERIMENTAL

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

Interventions

Usual CareBEHAVIORAL

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

Usual care
FAST protocolBEHAVIORAL

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.

FAST protocol

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lions Gate Hospital

North Vancouver, British Columbia, V7L 2L7, Canada

Location

Holy Family Hospital

Vancouver, British Columbia, V5P 3L6, Canada

Location

Related Publications (2)

  • 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.

    PMID: 25300433BACKGROUND

  • 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.

    PMID: 32168159DERIVED

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • S. Jayne Garland, PT, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 9, 2012

Study Start

November 1, 2012

Primary Completion

March 31, 2017

Study Completion

June 30, 2017

Last Updated

May 1, 2026

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)