StrokeNCT02964039
A Novel Mechanics-based Intervention to Improve Post-stroke Stability
A study testing Error reduction and Error augmentation in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a novel treadmill training intervention can improve the gait stabilization strategy used by individuals who have experienced a stroke. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Error reduction and Error augmentation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 21 years old
- Experience of a stroke 6 months prior to participation
- Preferred overground gait speed of at least 0.2 m/s
- Ability to walk at self-selected speed for 3 minutes without a cane or walker
- Provision of informed consent.
Who cannot join
- Resting heart rate above 110 beats/min
- Resting blood pressure higher than 200/110 mm Hg
- History of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- Preexisting neurological disorders or dementia
- History of major head trauma
- Legal blindness or severe visual impairment
Show all 10Show fewer
- Life expectancy <1 yr; 8)
- History of deep vein thrombosis or pulmonary embolism within 6 months
- Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
- Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799
About this study
Official title: A Novel Mechanics-based Intervention to Improve Post-stroke Gait Stability
The purpose of this study is to determine whether a novel treadmill training intervention can improve the gait stabilization strategy used by individuals who have experienced a stroke.
Read the detailed description
Every year, approximately 15,000 American Veterans experience a stroke, with an estimated cost of acute and follow-up care in the hundreds of millions of dollars. Following a stroke, the restoration or improvement of walking is a high-ranking goal among patients, but only about half of the population is able to return to typical levels of community ambulation. The resultant decrease in independent mobility is strongly associated with a decline in quality of life. Gait instability is a common contributor to limited mobility through either an increased fall-risk or fear of falling, but current interventions to address post-stroke gait instability have had limited success. This project will conduct initial testing of a novel elastic force-field designed to improve post-stroke gait stability through targeted motor learning. The results of these experiments will serve as the basis for the development of novel gait rehabilitation techniques, which have the potential to increase the quality of life of thousands of Veterans and save millions of dollars.
- Conditions
- Stroke
- Being tested
- Error reduction, Error augmentation, Activity matched control
- Keywords
- stroke, rehabilitation, gait
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Error reductionBehavioural
During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.
Error augmentationBehavioural
During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.
Activity matched controlBehavioural
During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.
| Study group | Role | What they receive |
|---|---|---|
| Error reduction | Experimental | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Receives: Behavioral: Error reduction |
| Error augmentation | Experimental | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Receives: Behavioral: Error augmentation |
| Activity matched control | Sham comparator | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Receives: Behavioral: Activity matched control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)
A custom measure that quantifies the strength of the relationship between body mechanics and foot placement. This measure falls within a relatively narrow range among neurologically intact controls, but is substantially reduced in some individuals who have experienced a stroke, indicating a reduced ability to stabilize their gait pattern. This measure relates the mechanical state of the body at the start of each step (mediolateral pelvis displacement and velocity of the pelvis relative to the stance foot) to the step width at the end of the step. Specifically, the partial linear correlation between pelvis displacement and step width was calculated, accounting for variation in pelvis velocity.
The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
Measured: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Secondary outcomes (5)
Functional Gait Assessment (Change From Baseline)
A commonly-used clinical test to quantify balance and stability during various walking tasks. The minimum value is 0, the maximum value is 30, and higher scores indicate better outcomes. The total maximum value of 30 is calculated as the sum of 10 subscores, each of which has a scoring range of 0-3 and represents a distinct walking task.
The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
Measured: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Activities-specific Balance Confidence Scale (Change From Baseline)
A commonly-used clinical scale that quantifies an individual's confidence in performing various tasks requiring balance. The minimum value is 0, the maximum value is 100, and higher scores indicate a better outcome. The overall score is calculated as the mean of 16 subscores, each of which can range of 0 to 100 and represents self-efficacy at a distinct movement task.
The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
Measured: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
10-meter Walk Test (Change From Baseline)
A commonly-used clinical test to quantify general gait function. Walking speed is measured during the middle 6-meter portion of a 10-meter straight line path.
The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
Measured: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Fall Incidence
Self-report history of fall occurrence, quantified by the average number of falls per participant in each group during the 12-week period that followed completion of the study's intervention component
Measured: 6 months (during 12 week follow-up period)
Fear of Falling
Self-report statement of whether a participant has a fear of falling
Measured: 6 months (at completion of 12-week Follow-up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start1 Apr 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jesse C. Dean, PhD, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964039
- Sponsor's protocol ID
- N2256-R
- Other IDs
- RX002256
- Status last verified
- Dec 2023
- First submitted
- 4 Nov 2016
- Last updated
- 3 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, anonymized data sets will be available to other investigators or members of the public upon request. These data sets will be made available upon completion of data collection, processing, and initial statistical analyses. The data sets will include physiological measures related to functional mobility, as well as the results of clinical tests.
Publications
Krause AA, Reimold NK, Embry AE, Knight HL, Jacobs CJ, Boan AD, Dean JC. Effect of mediolateral leg perturbations on walking balance in people with chronic stroke: A randomized controlled trial. PLoS One. 2024 Oct 8;19(10):e0311727. doi: 10.1371/journal.pone.0311727. eCollection 2024.
PubMed 39378234
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Mechanics-based Intervention to Improve Post-stroke Gait Stability
- ClinicalTrials.gov ID
- NCT02964039
- Acronym / sponsor ID
- N2256-R
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Posted 28 Jul 2021
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 determine whether a novel treadmill training intervention can improve the gait stabilization strategy used by individuals who have experienced a stroke.
Detailed description
Every year, approximately 15,000 American Veterans experience a stroke, with an estimated cost of acute and follow-up care in the hundreds of millions of dollars. Following a stroke, the restoration or improvement of walking is a high-ranking goal among patients, but only about half of the population is able to return to typical levels of community ambulation. The resultant decrease in independent mobility is strongly associated with a decline in quality of life. Gait instability is a common contributor to limited mobility through either an increased fall-risk or fear of falling, but current interventions to address post-stroke gait instability have had limited success. This project will conduct initial testing of a novel elastic force-field designed to improve post-stroke gait stability through targeted motor learning. The results of these experiments will serve as the basis for the development of novel gait rehabilitation techniques, which have the potential to increase the quality of life of thousands of Veterans and save millions of dollars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Error reduction | Experimental | Behavioral: Error reductionParticipants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. |
| Error augmentation | Experimental | Behavioral: Error augmentationParticipants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. |
| Activity matched control | Sham comparator | Behavioral: Activity matched controlParticipants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 21 years old
- Experience of a stroke 6 months prior to participation
- Preferred overground gait speed of at least 0.2 m/s
- Ability to walk at self-selected speed for 3 minutes without a cane or walker
- Provision of informed consent.
Key exclusion criteria (10 listed)
- Resting heart rate above 110 beats/min
- Resting blood pressure higher than 200/110 mm Hg
- History of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- Preexisting neurological disorders or dementia
- History of major head trauma
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 |
|---|---|---|
| Error reductionDuring training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke. | Behavioural | Error reduction |
| Error augmentationDuring training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke. | Behavioural | Error augmentation |
| Activity matched controlDuring training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke. | Behavioural | Activity matched control |
Primary outcome
Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)
Time frame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
A custom measure that quantifies the strength of the relationship between body mechanics and foot placement. This measure falls within a relatively narrow range among neurologically intact controls, but is substantially reduced in some individuals who have experienced a stroke, indicating a reduced ability to stabilize their gait pattern. This measure relates the mechanical state of the body at the start of each step (mediolateral pelvis displacement and velocity of the pelvis relative to the stance foot) to the step width at the end of the step. Specifically, the partial linear correlation between pelvis displacement and step width was calculated, accounting for variation in pelvis velocity. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
5 secondary outcomes
Functional Gait Assessment (Change From Baseline)
Time frame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Activities-specific Balance Confidence Scale (Change From Baseline)
Time frame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
10-meter Walk Test (Change From Baseline)
Time frame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Fall Incidence
Time frame: 6 months (during 12 week follow-up period)
Fear of Falling
Time frame: 6 months (at completion of 12-week Follow-up period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39378234Krause AA, Reimold NK, Embry AE, Knight HL, Jacobs CJ, Boan AD, Dean JC. Effect of mediolateral leg perturbations on walking balance in people with chronic stroke: A randomized controlled trial. PLoS One. 2024 Oct 8;19(10):e0311727. doi: 10.1371/journal.pone.0311727. eCollection 2024.
- Individual participant dataSharing planned: Yes. De-identified, anonymized data sets will be available to other investigators or members of the public upon request. These data sets will be made available upon completion of data collection, processing, and initial statistical analyses. The data sets will include physiological measures related to functional mobility, as well as the results of clinical tests.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
Jesse C. Dean, PhD principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Error reduction and Error augmentation in people with Stroke, run by VA Office of Research and Development 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 5 inclusion and 10 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 3 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 28 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) (time frame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks). 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 NCT02964039, 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 3 Jun 2024.