Hemiparesis;Poststroke/CVANCT04314830
Gait Perturbations to Improve Balance Post-stroke
A study testing Gait training with perturbations and Gait training without perturbation in people with Hemiparesis;Poststroke/CVA, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemiparesis;Poststroke/CVA
- What is being tested?
- Gait training with perturbations and Gait training without perturbation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2016to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Unpredictable Perturbations During Gait to Improve Balance Performance, Confidence and Participation in Persons With Hemiparesis at a Chronic Stage: a Pilot Study
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
- Being tested
- Gait training with perturbations, Gait training without perturbation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait training with perturbationsDevice
Changes in speed of one of the belt of the split belt treadmill during swing phase
Gait training without perturbationDevice
Walking on a treadmill with steady belt speed
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Gait training with perturbations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance capacities
Score at the mini-Balance Evaluation System Test (mini-BESTest). Score between 0 and 28. Higher scores associated with better balance abilities.
Measured: 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.
Measured: Within the week post-training
Gait capacities
Self-selected and fast gait speed measured over 10 meters (10 meter walking test)
Measured: Within the week pre-training
Gait capacities
Self-selected and fast gait speed measured over 10 meters (10 meter walking test)
Measured: Within the week post-training
Secondary outcomes (8)
Paretic and non-paretic maximal knee extensor strength
Measure of isometric, maximal knee extensor strength at each knee, using an instrumented dynamometer (Biodex).
Measured: Within the week pre-training
Paretic and non-paretic maximal knee extensor strength
Measure of isometric, maximal knee extensor strength at each knee, using an instrumented dynamometer (Biodex)
Measured: Within the week post-training
Balance confidence
Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence
Measured: Within the week pre-training
Balance confidence
Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence
Measured: Within the week post-training
Balance confidence
Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence
Measured: 6 weeks post training
Community reintegration
Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration.
Measured: Within the week pre-training
Community reintegration
Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration.
Measured: Within the week post-training
Community reintegration
Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration.
Measured: 6 weeks post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start5 Aug 2016
- Primary completion14 Sep 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemiparesis;Poststroke/CVAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cyril Duclos, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Investigators
- Cyril Duclos, PhD, Principal investigator, Université de Montréal - CRIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314830
- Sponsor's protocol ID
- CRIR-998-0914
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32552850
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unpredictable Perturbations During Gait to Improve Balance Performance, Confidence and Participation in Persons With Hemiparesis at a Chronic Stage: a Pilot Study
- ClinicalTrials.gov ID
- NCT04314830
- Acronym / sponsor ID
- CRIR-998-0914
- Conditions
- Hemiparesis;Poststroke/CVA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater MontrealUniversity, hospital or other
- Study start
- 5 Aug 2016 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Gait training without perturbation | Active comparator | Device: Gait training without perturbationWalking 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 |
| Gait training with perturbations | Experimental | Device: Gait training with perturbationsWalking 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait training with perturbationsChanges in speed of one of the belt of the split belt treadmill during swing phase | Device | Gait training with perturbations |
| Gait training without perturbationWalking on a treadmill with steady belt speed | Device | Gait training without perturbation |
Primary outcome
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.
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.
Gait capacities
Time frame: Within the week pre-training
Self-selected and fast gait speed measured over 10 meters (10 meter walking test)
Gait capacities
Time frame: Within the week post-training
Self-selected and fast gait speed measured over 10 meters (10 meter walking test)
8 secondary outcomes
Paretic and non-paretic maximal knee extensor strength
Time frame: Within the week pre-training
Paretic and non-paretic maximal knee extensor strength
Time frame: Within the week post-training
Balance confidence
Time frame: Within the week pre-training
Balance confidence
Time frame: Within the week post-training
Balance confidence
Time frame: 6 weeks post training
Community reintegration
Time frame: Within the week pre-training
Community reintegration
Time frame: Within the week post-training
Community reintegration
Time frame: 6 weeks post training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Derived from this study: PubMed 32552850Esmaeili 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.
- Individual participant dataSharing planned: No
Related trials for Hemiparesis;Poststroke/CVA
Active, not recruiting
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Characterization of Muscle Activity During a Surface EMG-controlled Rehabilitation Game
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Development and Efficacy of a Novel, Cost-Effective Gait Training Device Utilized at Home for Stroke Survivors
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RecruitingPhase 2
Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors
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A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors
Stroke, Stroke Sequelae
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyril Duclos, PhD principal investigator
Université de Montréal - CRIR
Questions about this trial
What is this clinical trial studying?
A study testing Gait training with perturbations and Gait training without perturbation in people with Hemiparesis;Poststroke/CVA, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance capacities (time frame: Within the week pre-training). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04314830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020; AzTrials last refreshed its copy on 29 Oct 2026.