Clinical trial NCT04314830: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis;Poststroke/CVA
Lead sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Balance capacities
timeFrame: Within the week pre-training
measure: Balance capacities
timeFrame: Within the week post-training
measure: Gait capacities
timeFrame: Within the week pre-training
measure: Gait capacities
timeFrame: Within the week post-training
Secondary outcomes:
measure: Paretic and non-paretic maximal knee extensor strength
timeFrame: Within the week pre-training
measure: Paretic and non-paretic maximal knee extensor strength
timeFrame: Within the week post-training
measure: Balance confidence
timeFrame: Within the week pre-training
measure: Balance confidence
timeFrame: Within the week post-training
measure: Balance confidence
timeFrame: 6 weeks post training
measure: Community reintegration
timeFrame: Within the week pre-training
measure: Community reintegration
timeFrame: Within the week post-training
measure: Community reintegration
timeFrame: 6 weeks post training
Other outcomes:
measure: Satisfaction with gait perturbation intervention
timeFrame: Within the week post-training
measure: Laboratory gait analysis : kinematics
timeFrame: Within the week pre-training
measure: Laboratory gait analysis : kinematics
timeFrame: Within the week post-training
measure: Laboratory gait analysis : kinetics
timeFrame: Within the week pre-training
measure: Laboratory gait analysis : kinetics
timeFrame: Within the week post-training
measure: Laboratory gait analysis : electromyographic activity
timeFrame: Within the week pre-training
measure: Laboratory gait analysis : electromyographic activity
timeFrame: Within the week post-training
Locations:
Study officials:
affiliation: Université de Montréal - CRIR
name: Cyril Duclos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.