Gait Perturbations to Improve Balance Post-stroke

Not Applicable

Completed

• Conditions: Hemiparesis;Poststroke/CVA
• Interventions: Device: Gait training with perturbations; Device: Gait training without perturbation

• Registration Number: NCT04314830
• Lead Sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Brief Summary

Individuals with stroke have balance and gait deficits. Gait training does improve balance and gait abilities, but adding perturbations may have increase these effects. The objective was to compare the effect gait training with and without perturbations on balance and gait abilities in individuals with hemiparesis due to stroke at a chronic stage.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-05
• Primary Completion: 2018-09-14
• Study Completion: 2018-10-30
• Status Verified: 2020-03
• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-17
• Last Update Submitted: 2020-03-17
• Study First Posted: 2020-03-19
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• able to walk at a comfortable speed less than 1.0 m/s
• have reduced dynamic balance capacities (as evaluated by the mini-BESTest; score below the 95% confidence interval of the mean score of the corresponding age group of normative data)
• with or without a history of fall
• be able to walk on a treadmill, without external support, such as handrails or walking aid, for at least 1 minute

Exclusion Criteria

• hemineglect (more than 6 omissions on the bell cancellation test),
• cognitive impairment (Mini-Mental State Examination score under 24/30)
• uncorrected visual deficit or pathologies other than stroke which can affect their gait or balance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Gait training with perturbations	Gait training with perturbations	Walking on a treadmill with perturbations produced by changes in the speed of one of the belt of the split-belt treadmill during one gait cycle. Changes in treadmill speed were applied on the paretic or non-paretic side, with and increase or a decrease of the speed of the belt in various magnitude. Perturbations were either repeated with the same characteristics or with different characteristics. Outside of perturbations, treadmill speed did not change along the training program.
Gait training without perturbation	Gait training without perturbation	Walking on a treadmill with the same duration as a participants of the experimental arm matched for initial gait speed. Treadmill speed did not change along the training program

Primary Outcome Measures

Name	Time	Method
Balance capacities	Within the week post-training	Score at the mini-Balance Evaluation System Test (mini-BESTest). Score between 0 and 28. Higher scores associated with better balance abilities.
Gait capacities	Within the week post-training	Self-selected and fast gait speed measured over 10 meters (10 meter walking test)

Secondary Outcome Measures

Name	Time	Method
Community reintegration	6 weeks post training	Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration.
Paretic and non-paretic maximal knee extensor strength	Within the week post-training	Measure of isometric, maximal knee extensor strength at each knee, using an instrumented dynamometer (Biodex)
Balance confidence	6 weeks post training	Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence