Stroke, CerebrovascularNCT05772936
Reactive Standing Balance Step Training Post Stroke
A study testing Balance training in people with Stroke, Cerebrovascular, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effectiveness of reactive step training on the timing and frequency of perturbation induced paretic leg stepping in persons post stroke. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke, Cerebrovascular
- What is being tested?
- Balance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2019to 6 Feb 2023
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 1 year post a single unilateral hemispheric stroke (CVA)
- living independently in the community
- able to walk 25 feet without assistive device
Who cannot join
- pain that limits movement
- joint surgery of the lower extremity
- unable to give consent
- significant postural alignment deficits such as scoliosis or genu recurvatum
- loss of sensation in the lower limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perturbation-induced Reactive Standing BalanceTraining in Persons Post Stroke
The purpose of this study is to investigate the effectiveness of reactive step training on the timing and frequency of perturbation induced paretic leg stepping in persons post stroke. The study will consist of one or six one-hour training sessions and a pre and post visit each lasting up to two hours at our downtown Chicago location.
Read the detailed description
Perturbation induced step training. Perturbations will be applied by a mechanical weight drop system that has been used in previous studies. A belt with a cable will be attached to the subject's waist. The cable will be attached to metal weights that is held by an electromagnet on a vertical pole approximately 10-12ft from the subject. The weight will drop 52cm when the electromagnet is released. When the subject has attained and held a predetermined standing position for 1-3 seconds the mechanical perturbation will be activated. See training protocol below.
Pre and Post Testing Sessions: Subjects will be asked to complete pre and post testing sessions within 1 week of training. Testing sessions will include laboratory and clinical measures of balance and will last for approximately one hour.
Laboratory Measures: Participants will complete 2 standing trials, 12 voluntary stepping trials, and 12 anterior perturbation trials while standing on force platforms.
Standing trials: Subjects will be asked to stand feet hip with apart with each foot on a separate force plate that measure the pressure under their feet. Their foot placement will be traced so they can return to the same placement for each trial. Subjects will be instructed to cross their arms and stand as still as they can for 3 seconds, then march in place for 3 seconds.
Voluntary Stepping Trials: While standing with their feet in their foot tracings subjects will be asked to shift their weight until they assume a predetermined pressure under each foot. Visual feedback will be provided on a monitor in front of them. They will be instructed to hold that position until they see the "Go" cue on the screen at which point they should take 3 steps forward as fast as they can. There will be 6 stepping trials on each leg starting with the less involved leg.
Reactive Stepping Trials: Subjects will be secured in a safety harness that is mounted to the ceiling. The harness does not interfere with stepping but allows the person body weight to be supported if there is a loss of balance. A belt will be placed around the subjects' waist that will be connected by a cable to a mechanical weight drop device that will pull the subject forward to challenge their balance. The puller will provide mechanical perturbations up to 10% of subjects' body weight. The subjects will be instructed not resist the pull but to respond naturally and move their feet if needed to maintain up right posture. There will be ten reactive trials. Rest breaks will be given between voluntary and reactive trials or as needed.
Participants will complete 6 training sessions within a three-week period. Subjects will stand with their feet on a platform with a scale. Subjects will be instructed to try to use their more impaired leg if they need to step. The same mechanical perturbation that was used in the pre/post testing will be used for training with the belt attached to their waist. When they have attained and held a predetermined standing position for 1-3 seconds the mechanical perturbation will be activated. The weight bearing status of the more impaired leg will be increased by 5% after 10 out of 12 successive trials (i.e. stepping with the more impaired leg) or decreased by 5% if they always step with the less impaired leg after 6 trials. Training sessions will consist of 50 perturbation trials at 10% body weight and 3 catch trials at 2% body weight to discourage premature stepping. Training session will last about 1 hour. Subjects will be given rest breaks as needed.
- Conditions
- Stroke, Cerebrovascular
- Being tested
- Balance training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingBehavioural
perturbation induce step training to improve reactive stepping with paretic leg.
| Study group | Role | What they receive |
|---|---|---|
| single arm non-randomized | Experimental | all enrolled subjects will participate in the perturbation-induced step training, 1 or 6 sessions about 1-1.5 hour (30-90 trials) each session. Receives: Behavioral: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of stepping with paretic leg after a perturbation
number of trials when the paretic leg takes the first reactive step after the perturbation is applied during the reactive trials.
Measured: Change in stepping with paretic leg will be modeled from baseline and immediately after the intervention.
Change in step onset time for voluntary and reactive steps
step onset time is the time the stepping foot lifts off the ground after the Go cue for voluntary steps and after the perturbation for the reactive steps.
Measured: Change in step onset will be modeled from baseline and immediately after the intervention.
Change in reactive lean balance test
Lean balance test is a passive way to test reactive stepping. Participants will lean again the research staff hands until their center of mass is at the edge of their feet. The research staff will suddenly remove their hands and allow the participant to catch their balance. Research staff are trained to perform the test and to guard the participant if needed. Extra personnel will be near by for additional support if the participant is not able to recover their balance.
Measured: Change in reactive lean balance test will be modeled from baseline and immediately after the intervention.
Secondary outcomes (2)
10 meter walk test
subject walking will be timed at comfortable and fast speed over a 10 meter distance.
Measured: Day 1 before training
Activities-specific Balance Confidence scale (ABC)
The ABC is a sixteen item questionnaire that ask subjects to rate their balance confidence on various daily activities. Scores range from 10 to 100 on each item, with total score the average of all responses. Higher score indicate more balance confidence, low score indicate less balance confidence.
Measured: Day 1 before training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start22 Jan 2019
- Primary completion6 Feb 2023
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, CerebrovascularStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Martinez, Northwestern University
- Investigators
- Katherine M Martinez, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772936
- Sponsor's protocol ID
- RST4CVA2018
- Status last verified
- Mar 2023
- First submitted
- 24 Oct 2019
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perturbation-induced Reactive Standing BalanceTraining in Persons Post Stroke
- ClinicalTrials.gov ID
- NCT05772936
- Acronym / sponsor ID
- RST4CVA2018
- Conditions
- Stroke, Cerebrovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 17 Mar 2023 (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.
The purpose of this study is to investigate the effectiveness of reactive step training on the timing and frequency of perturbation induced paretic leg stepping in persons post stroke. The study will consist of one or six one-hour training sessions and a pre and post visit each lasting up to two hours at our downtown Chicago location.
Detailed description
Perturbation induced step training. Perturbations will be applied by a mechanical weight drop system that has been used in previous studies. A belt with a cable will be attached to the subject's waist. The cable will be attached to metal weights that is held by an electromagnet on a vertical pole approximately 10-12ft from the subject. The weight will drop 52cm when the electromagnet is released. When the subject has attained and held a predetermined standing position for 1-3 seconds the mechanical perturbation will be activated. See training protocol below.
Pre and Post Testing Sessions: Subjects will be asked to complete pre and post testing sessions within 1 week of training. Testing sessions will include laboratory and clinical measures of balance and will last for approximately one hour.
Laboratory Measures: Participants will complete 2 standing trials, 12 voluntary stepping trials, and 12 anterior perturbation trials while standing on force platforms.
Standing trials: Subjects will be asked to stand feet hip with apart with each foot on a separate force plate that measure the pressure under their feet. Their foot placement will be traced so they can return to the same placement for each trial. Subjects will be instructed to cross their arms and stand as still as they can for 3 seconds, then march in place for 3 seconds.
Voluntary Stepping Trials: While standing with their feet in their foot tracings subjects will be asked to shift their weight until they assume a predetermined pressure under each foot. Visual feedback will be provided on a monitor in front of them. They will be instructed to hold that position until they see the "Go" cue on the screen at which point they should take 3 steps forward as fast as they can. There will be 6 stepping trials on each leg starting with the less involved leg.
Reactive Stepping Trials: Subjects will be secured in a safety harness that is mounted to the ceiling. The harness does not interfere with stepping but allows the person body weight to be supported if there is a loss of balance. A belt will be placed around the subjects' waist that will be connected by a cable to a mechanical weight drop device that will pull the subject forward to challenge their balance. The puller will provide mechanical perturbations up to 10% of subjects' body weight. The subjects will be instructed not resist the pull but to respond naturally and move their feet if needed to maintain up right posture. There will be ten reactive trials. Rest breaks will be given between voluntary and reactive trials or as needed.
Participants will complete 6 training sessions within a three-week period. Subjects will stand with their feet on a platform with a scale. Subjects will be instructed to try to use their more impaired leg if they need to step. The same mechanical perturbation that was used in the pre/post testing will be used for training with the belt attached to their waist. When they have attained and held a predetermined standing position for 1-3 seconds the mechanical perturbation will be activated. The weight bearing status of the more impaired leg will be increased by 5% after 10 out of 12 successive trials (i.e. stepping with the more impaired leg) or decreased by 5% if they always step with the less impaired leg after 6 trials. Training sessions will consist of 50 perturbation trials at 10% body weight and 3 catch trials at 2% body weight to discourage premature stepping. Training session will last about 1 hour. Subjects will be given rest breaks as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm non-randomized | Experimental | Behavioral: Balance trainingall enrolled subjects will participate in the perturbation-induced step training, 1 or 6 sessions about 1-1.5 hour (30-90 trials) each session. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 1 year post a single unilateral hemispheric stroke (CVA)
- living independently in the community
- able to walk 25 feet without assistive device
Key exclusion criteria (5 listed)
- pain that limits movement
- joint surgery of the lower extremity
- unable to give consent
- significant postural alignment deficits such as scoliosis or genu recurvatum
- loss of sensation in the lower limb
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 |
|---|---|---|
| Balance trainingperturbation induce step training to improve reactive stepping with paretic leg. | Behavioural | single arm non-randomized |
Primary outcome
Change in frequency of stepping with paretic leg after a perturbation
Time frame: Change in stepping with paretic leg will be modeled from baseline and immediately after the intervention.
number of trials when the paretic leg takes the first reactive step after the perturbation is applied during the reactive trials.
Change in step onset time for voluntary and reactive steps
Time frame: Change in step onset will be modeled from baseline and immediately after the intervention.
step onset time is the time the stepping foot lifts off the ground after the Go cue for voluntary steps and after the perturbation for the reactive steps.
Change in reactive lean balance test
Time frame: Change in reactive lean balance test will be modeled from baseline and immediately after the intervention.
Lean balance test is a passive way to test reactive stepping. Participants will lean again the research staff hands until their center of mass is at the edge of their feet. The research staff will suddenly remove their hands and allow the participant to catch their balance. Research staff are trained to perform the test and to guard the participant if needed. Extra personnel will be near by for additional support if the participant is not able to recover their balance.
2 secondary outcomes
10 meter walk test
Time frame: Day 1 before training
Activities-specific Balance Confidence scale (ABC)
Time frame: Day 1 before 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 17 Mar 2023.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication.
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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.
Katherine M Martinez, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training in people with Stroke, Cerebrovascular, run by Northwestern University at 1 site in United States.
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 3 inclusion and 5 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 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in frequency of stepping with paretic leg after a perturbation (time frame: Change in stepping with paretic leg will be modeled from baseline and immediately after the intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2023.