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Completed

NCT Number: NCT04314830

Gait Perturbations to Improve Balance Post-stroke

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.

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Key information

Conditions

Hemiparesis;Poststroke/CVA

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gait training with perturbations

Device

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

Gait training without perturbation

Device

Walking on a treadmill with steady belt speed

Primary outcomes

  1. Balance capacities

    Time frame: Within the week pre-training

    Score at the mini-Balance Evaluation System Test (mini-BESTest). Score between 0 and 28. Higher scores associated with better balance abilities.

  2. Balance capacities

    Time frame: 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.

  3. Gait capacities

    Time frame: Within the week pre-training

    Self-selected and fast gait speed measured over 10 meters (10 meter walking test)

  4. Gait capacities

    Time frame: Within the week post-training

    Self-selected and fast gait speed measured over 10 meters (10 meter walking test)

Secondary outcomes

  1. Paretic and non-paretic maximal knee extensor strength

    Time frame: Within the week pre-training

    Measure of isometric, maximal knee extensor strength at each knee, using an instrumented dynamometer (Biodex).

  2. Paretic and non-paretic maximal knee extensor strength

    Time frame: Within the week post-training

    Measure of isometric, maximal knee extensor strength at each knee, using an instrumented dynamometer (Biodex)

  3. Balance confidence

    Time frame: Within the week pre-training

    Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence

  4. Balance confidence

    Time frame: Within the week post-training

    Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence

  5. Balance confidence

    Time frame: 6 weeks post training

    Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence

  6. Community reintegration

    Time frame: Within the week pre-training

    Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration.

  7. Community reintegration

    Time frame: Within the week post-training

    Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration.

  8. Community reintegration

    Time frame: 6 weeks post training

    Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration.

Other outcomes

  1. Satisfaction with gait perturbation intervention

    Time frame: Within the week post-training

    Score at the Short Feedback Questionnaire. Rating from "Not at all" to "Extremely" to 9 questions. No total score. Answers interpreted for each question.

  2. Laboratory gait analysis : kinematics

    Time frame: Within the week pre-training

    Lower-limb joint angles, centre of mass during gait at natural and fast speed and during gait perturbations

  3. Laboratory gait analysis : kinematics

    Time frame: Within the week post-training

    Lower-limb joint angles, centre of mass during gait at natural and fast speed and during gait perturbations

  4. Laboratory gait analysis : kinetics

    Time frame: Within the week pre-training

    Ground reaction forces and centre of pressure during gait at natural and fast speed and during gait perturbations

  5. Laboratory gait analysis : kinetics

    Time frame: Within the week post-training

    Ground reaction forces and centre of pressure during gait at natural and fast speed and during gait perturbations

  6. Laboratory gait analysis : electromyographic activity

    Time frame: Within the week pre-training

    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

  7. Laboratory gait analysis : electromyographic activity

    Time frame: Within the week post-training

    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

Sponsors and collaborators

Lead sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2020
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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