Gait Perturbations to Improve Balance Post-stroke

NCT ID: NCT04314830

Last Updated: 2020-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-05

Study Completion Date

2018-10-30

Brief Summary

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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

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Conditions

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Hemiparesis;Poststroke/CVA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Only the experimental intervention was offered in the second phase of the trial, to the participants who received the control intervention in the first phase
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome measures pretraining were collected pre-randomization. Post-training, the assessors were masked for the arm.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Gait training without perturbation

Intervention Type DEVICE

Walking on a treadmill with steady belt speed

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.

Group Type EXPERIMENTAL

Gait training with perturbations

Intervention Type DEVICE

Changes in speed of one of the belt of the split belt treadmill during swing phase

Interventions

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Gait training with perturbations

Changes in speed of one of the belt of the split belt treadmill during swing phase

Intervention Type DEVICE

Gait training without perturbation

Walking on a treadmill with steady belt speed

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

OTHER

Sponsor Role lead

Responsible Party

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Cyril Duclos

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cyril Duclos, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal - CRIR

References

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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.

Reference Type DERIVED
PMID: 32552850 (View on PubMed)

Other Identifiers

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CRIR-998-0914

Identifier Type: -

Identifier Source: org_study_id

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