Gait Perturbations to Improve Balance Post-stroke

Unpredictable Perturbations During Gait to Improve Balance Performance, Confidence and Participation in Persons With Hemiparesis at a Chronic Stage: a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Hemiparesis;Poststroke/CVA
• Intervention / Treatment: Device: Gait training without perturbation; Device: Gait training with perturbations

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: Gait training without perturbation; Walking on a treadmill with steady belt speed
Experimental: 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.	Device: Gait training with perturbations; Changes in speed of one of the belt of the split belt treadmill during swing phase

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with gait perturbation intervention	Score at the Short Feedback Questionnaire. Rating from "Not at all" to "Extremely" to 9 questions. No total score. Answers interpreted for each question.	Within the week post-training
Laboratory gait analysis : kinematics	Lower-limb joint angles, centre of mass during gait at natural and fast speed and during gait perturbations	Within the week pre-training
Laboratory gait analysis : kinematics	Lower-limb joint angles, centre of mass during gait at natural and fast speed and during gait perturbations	Within the week post-training
Laboratory gait analysis : kinetics	Ground reaction forces and centre of pressure during gait at natural and fast speed and during gait perturbations	Within the week pre-training
Laboratory gait analysis : kinetics	Ground reaction forces and centre of pressure during gait at natural and fast speed and during gait perturbations	Within the week post-training
Laboratory gait analysis : electromyographic activity	EMG activity of 5 muscle groups (tibialis anterior, soleus, rectus femoris, medial hamstring, paravertebral muscles at L3) bilateraly during gait at natural and fast speed and during gait perturbations	Within the week pre-training
Laboratory gait analysis : electromyographic activity	EMG activity of 5 muscle groups (tibialis anterior, soleus, rectus femoris, medial hamstring, paravertebral muscles at L3) bilateraly during gait at natural and fast speed and during gait perturbations	Within the week post-training

Collaborators and Investigators

• Sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
• Investigators: Principal Investigator: Cyril Duclos, PhD, Université de Montréal - CRIR

Publications and helpful links

General Publications

• Esmaeili V, Juneau A, Dyer JO, Lamontagne A, Kairy D, Bouyer L, Duclos C. Intense and unpredictable perturbations during gait training improve dynamic balance abilities in chronic hemiparetic individuals: a randomized controlled pilot trial. J Neuroeng Rehabil. 2020 Jun 17;17(1):79. doi: 10.1186/s12984-020-00707-0.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2016
• Primary Completion (Actual): September 14, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: CRIR-998-0914

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes