Gait Perturbations to Improve Balance Post-stroke

NCT04314830 | Completed FDA Device

• 1 other identifier: CRIR-998-0914
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemiparesis;Poststroke/CVA

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Paretic and non-paretic maximal knee extensor strength

  Within the week pre-training

• Paretic and non-paretic maximal knee extensor strength

  Within the week post-training

• Balance confidence

  Within the week pre-training

• Balance confidence

  Within the week post-training

• Balance confidence

  6 weeks post training

Other Outcomes (7)

• Satisfaction with gait perturbation intervention

  Within the week post-training

• Laboratory gait analysis : kinematics

  Within the week pre-training

• Laboratory gait analysis : kinematics

  Within the week post-training

Study Arms (2)

Gait training without perturbation

ACTIVE COMPARATOR

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

Gait training with perturbations

EXPERIMENTAL

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

Interventions

Gait training with perturbations DEVICE

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

Gait training with perturbations

Gait training without perturbation DEVICE

Walking on a treadmill with steady belt speed

Gait training without perturbation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal: lead

Related Publications (1)

• 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.

  PMID: 32552850 DERIVED

Study Officials

• Cyril Duclos, PhD

  Université de Montréal - CRIR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures pretraining were collected pre-randomization. Post-training, the assessors were masked for the arm.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 19, 2020
• Study Start: August 5, 2016
• Primary Completion: September 14, 2018
• Study Completion: October 30, 2018
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share