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Gait Perturbations to Improve Balance Post-stroke

Primary Purpose

Hemiparesis;Poststroke/CVA

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gait training with perturbations
Gait training without perturbation
Sponsored by
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiparesis;Poststroke/CVA

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Gait training without perturbation

    Gait training with perturbations

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 12, 2020
    Last Updated
    March 17, 2020
    Sponsor
    Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04314830
    Brief Title
    Gait Perturbations to Improve Balance Post-stroke
    Official Title
    Unpredictable Perturbations During Gait to Improve Balance Performance, Confidence and Participation in Persons With Hemiparesis at a Chronic Stage: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 5, 2016 (Actual)
    Primary Completion Date
    September 14, 2018 (Actual)
    Study Completion Date
    October 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemiparesis;Poststroke/CVA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    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
    Masking
    Outcomes Assessor
    Masking Description
    Outcome measures pretraining were collected pre-randomization. Post-training, the assessors were masked for the arm.
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Gait training without perturbation
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Gait training with perturbations
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Gait training with perturbations
    Intervention Description
    Changes in speed of one of the belt of the split belt treadmill during swing phase
    Intervention Type
    Device
    Intervention Name(s)
    Gait training without perturbation
    Intervention Description
    Walking on a treadmill with steady belt speed
    Primary Outcome Measure Information:
    Title
    Balance capacities
    Description
    Score at the mini-Balance Evaluation System Test (mini-BESTest). Score between 0 and 28. Higher scores associated with better balance abilities.
    Time Frame
    Within the week pre-training
    Title
    Balance capacities
    Description
    Score at the mini-Balance Evaluation System Test (mini-BESTest). Score between 0 and 28. Higher scores associated with better balance abilities.
    Time Frame
    Within the week post-training
    Title
    Gait capacities
    Description
    Self-selected and fast gait speed measured over 10 meters (10 meter walking test)
    Time Frame
    Within the week pre-training
    Title
    Gait capacities
    Description
    Self-selected and fast gait speed measured over 10 meters (10 meter walking test)
    Time Frame
    Within the week post-training
    Secondary Outcome Measure Information:
    Title
    Paretic and non-paretic maximal knee extensor strength
    Description
    Measure of isometric, maximal knee extensor strength at each knee, using an instrumented dynamometer (Biodex).
    Time Frame
    Within the week pre-training
    Title
    Paretic and non-paretic maximal knee extensor strength
    Description
    Measure of isometric, maximal knee extensor strength at each knee, using an instrumented dynamometer (Biodex)
    Time Frame
    Within the week post-training
    Title
    Balance confidence
    Description
    Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence
    Time Frame
    Within the week pre-training
    Title
    Balance confidence
    Description
    Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence
    Time Frame
    Within the week post-training
    Title
    Balance confidence
    Description
    Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence
    Time Frame
    6 weeks post training
    Title
    Community reintegration
    Description
    Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration.
    Time Frame
    Within the week pre-training
    Title
    Community reintegration
    Description
    Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration.
    Time Frame
    Within the week post-training
    Title
    Community reintegration
    Description
    Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration.
    Time Frame
    6 weeks post training
    Other Pre-specified Outcome Measures:
    Title
    Satisfaction with gait perturbation intervention
    Description
    Score at the Short Feedback Questionnaire. Rating from "Not at all" to "Extremely" to 9 questions. No total score. Answers interpreted for each question.
    Time Frame
    Within the week post-training
    Title
    Laboratory gait analysis : kinematics
    Description
    Lower-limb joint angles, centre of mass during gait at natural and fast speed and during gait perturbations
    Time Frame
    Within the week pre-training
    Title
    Laboratory gait analysis : kinematics
    Description
    Lower-limb joint angles, centre of mass during gait at natural and fast speed and during gait perturbations
    Time Frame
    Within the week post-training
    Title
    Laboratory gait analysis : kinetics
    Description
    Ground reaction forces and centre of pressure during gait at natural and fast speed and during gait perturbations
    Time Frame
    Within the week pre-training
    Title
    Laboratory gait analysis : kinetics
    Description
    Ground reaction forces and centre of pressure during gait at natural and fast speed and during gait perturbations
    Time Frame
    Within the week post-training
    Title
    Laboratory gait analysis : electromyographic activity
    Description
    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
    Time Frame
    Within the week pre-training
    Title
    Laboratory gait analysis : electromyographic activity
    Description
    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
    Time Frame
    Within the week post-training

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cyril Duclos, PhD
    Organizational Affiliation
    Université de Montréal - CRIR
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32552850
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Gait Perturbations to Improve Balance Post-stroke

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