StrokeNCT04855032
Post-stroke Perturbation Training
A study testing Reactive Perturbations and Proactive Perturbations in people with Stroke, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Following a stroke, many individuals have a high risk of falls, which can negatively influence quality of life. Unfortunately, current treatments have not effectively addressed this problem. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Reactive Perturbations and Proactive Perturbations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2021to 21 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experience of a stroke at least 6 months prior to participation
- Self-reported experience of a fall in the previous year, and/or a fear of falling
- Gait speed of at least 0.2 m/s
- Ability to walk on a treadmill without a cane or walker
- Provision of informed consent
Who cannot join
- Evidence of cerebellar damage
- Resting blood pressure higher than 220/110 mm Hg
- History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- Preexisting neurological disorders or dementia
- Legal blindness or severe visual impairment
- History of DVT 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
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Proactive and Reactive Perturbation Training to Reduce Falls and Improve Gait Stability in People With Chronic Stroke
Following a stroke, many individuals have a high risk of falls, which can negatively influence quality of life. Unfortunately, current treatments have not effectively addressed this problem. This study investigates whether two methods of delivering mechanical perturbations during walking have the potential to improve post-stroke walking balance and reduce real-world fall incidence.
- Conditions
- Stroke
- Being tested
- Reactive Perturbations, Proactive Perturbations
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reactive PerturbationsBehavioural
A novel device will be used to apply controlled mediolateral perturbations to participants' trunk as they walk on a treadmill, requiring reactive responses to avoid a loss of balance. All perturbations will have a duration of 200 ms, and will be applied immediately after onset of the swing phase with either the paretic or non-paretic leg. If in a given training session, a participant does not experience any losses of balance, the perturbation magnitude will be increased in the next training session. Perturbations will begin at 3% body weight (BW), and will progress in increments of 3% BW up to a maximum of 15% BW. The structure of the Reactive perturbation session will be identical to that used for Proactive perturbation training sessions, including overground trials, treadmill trials without perturbations, and Perturbed and Catch trials in which Perturbations are delivered.
Proactive PerturbationsBehavioural
A novel device will be used to perturb the relationship between pelvis motion and step width by applying mediolateral forces to participants' legs. Participants will first perform a 3-minute overground walking trial at their self-selected speed, in which they do not interact with the perturbation device. Participants will then perform a 3-minute treadmill walking trial at their self-selected speed, in which they again do not interact with the perturbation device. Participants will then perform a series of alternating 3-minute Perturbed and Catch trials, all at their self-selected speed. For the Perturbed trials, perturbations will be delivered in each step throughout the trial. For the Catch trials, perturbations will cease for the final minute of walking. A total of 5 Perturbed and 5 Catch trials will be performed. Finally, participants will perform a 3-minute overground walking trial at their self-selected speed, in which they do not interact with the perturbation device.
| Study group | Role | What they receive |
|---|---|---|
| Reactive Perturbations | Experimental | Not described Receives: Behavioral: Reactive Perturbations |
| Proactive Perturbations | Experimental | Not described Receives: Behavioral: Proactive Perturbations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall incidence
A fall will be defined as an event in which a participant loses their balance and comes to rest on the ground, floor, or lower level. Falls will be measured during the 12-week periods preceding and following the intervention, using 2-week calendars on postcards to be sent to the investigators.
Measured: 32 weeks (12-week period pre-intervention; 12-week period post-intervention)
Secondary outcomes (14)
Fear of falling
Participants will be asked if they have a fear of falling (yes/no).
Measured: 8 weeks (pre-intervention; post-intervention)
Functional Gait Assessment
A common clinical measure of gait balance
Measured: 8 weeks (pre-intervention; post-intervention)
Activities-specific Balance Confidence scale
A common clinical measure of balance self-efficacy
Measured: 8 weeks (pre-intervention; post-intervention)
Walking speed
Participants will be instructed to walk overground along a 10-meter path at the speed they would normally use around their house of the store. Speed will be measured for the middle 6-meters of the path.
Measured: 8 weeks (pre-intervention; post-intervention)
Foot placement stabilization strategy (mechanics)
We will calculate the partial correlation between the pelvis displacement at the start of each step, and step width at the end of the step, accounting for pelvis velocity.
Measured: 8 weeks (pre-intervention; post-intervention)
Foot placement stabilization strategy (gluteus medius activity)
We will calculate the partial correlation between the pelvis displacement at the start of each step, and the mean magnitude of gluteus medius activity during the first half of the swing phase, accounting for pelvis velocity.
Measured: 8 weeks (pre-intervention; post-intervention)
Center of pressure shift stabilization strategy (mechanics)
We will calculate the partial correlation between the pelvis velocity at the start of each step, and the magnitude of the change in mediolateral center of pressure location under the stance foot during the step, accounting for pelvis displacement.
Measured: 8 weeks (pre-intervention; post-intervention)
Center of pressure shift stabilization strategy (peroneus longus activity)
We will calculate the partial correlation between the pelvis velocity at the start of each step, and the mean magnitude of peroneus longus muscle activity during the single support stance phase of this step, accounting for pelvis displacement.
Measured: 8 weeks (pre-intervention; post-intervention)
Push-off stabilization strategy (mechanics)
We will calculate the partial correlation between the pelvis displacement at the start of each step, and the time integral of the total ground reaction force under the trail leg during the double support phase preceding this step, accounting for pelvis velocity.
Measured: 8 weeks (pre-intervention; post-intervention)
Push-off stabilization strategy (medial gastrocnemius activity)
We will calculate the partial correlation between the pelvis displacement at the start of each step, and the mean magnitude of medial gastrocnemius activity during the double support phase preceding this step, accounting for pelvis velocity.
Measured: 8 weeks (pre-intervention; post-intervention)
Largest rejected perturbation (trained perturbations) Largest rejected perturbation (trunk)
We will identify the largest mediolateral magnitude perturbation that participants can experience without a loss of balance.
Measured: 8 weeks (pre-intervention; post-intervention)
Largest rejected perturbation (untrained perturbations) Largest rejected perturbation (trunk)
We will identify the largest mediolateral magnitude perturbation that participants can experience without a loss of balance.
Measured: 8 weeks (pre-intervention; post-intervention)
Angular momentum modulation (trained perturbations) Largest rejected perturbation (trunk)
We will calculate the absolute difference in the range of frontal plane angular momentum during a step, relative to an unperturbed step. This will be calculated for the perturbed step and the subsequent recovery step.
Measured: 8 weeks (pre-intervention; post-intervention)
Angular momentum modulation (untrained perturbations) Largest rejected perturbation (trunk)
We will calculate the absolute difference in the range of frontal plane angular momentum during a step, relative to an unperturbed step. This will be calculated for the perturbed step and the subsequent recovery step.
Measured: 8 weeks (pre-intervention; post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start6 Oct 2021
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jesse Dean, Medical University of South Carolina
- Investigators
- Jesse Dean, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855032
- Sponsor's protocol ID
- 00101810
- Other IDs
- 1R01HD103923-01
- Status last verified
- Jul 2026
- First submitted
- 17 Apr 2021
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data consisting of the clinical assessments and biomechanical walking data collected in this study will be shared through the IPCSR website.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive and Reactive Perturbation Training to Reduce Falls and Improve Gait Stability in People With Chronic Stroke
- ClinicalTrials.gov ID
- NCT04855032
- Acronym / sponsor ID
- 00101810
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 22 Apr 2021 (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.
Following a stroke, many individuals have a high risk of falls, which can negatively influence quality of life. Unfortunately, current treatments have not effectively addressed this problem. This study investigates whether two methods of delivering mechanical perturbations during walking have the potential to improve post-stroke walking balance and reduce real-world fall incidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reactive Perturbations | Experimental | Behavioral: Reactive Perturbations |
| Proactive Perturbations | Experimental | Behavioral: Proactive Perturbations |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Experience of a stroke at least 6 months prior to participation
- Self-reported experience of a fall in the previous year, and/or a fear of falling
- Gait speed of at least 0.2 m/s
- Ability to walk on a treadmill without a cane or walker
- Provision of informed consent
Key exclusion criteria (8 listed)
- Evidence of cerebellar damage
- Resting blood pressure higher than 220/110 mm Hg
- History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- Preexisting neurological disorders or dementia
- Legal blindness or severe visual impairment
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 |
|---|---|---|
| Reactive PerturbationsA novel device will be used to apply controlled mediolateral perturbations to participants' trunk as they walk on a treadmill, requiring reactive responses to avoid a loss of balance. All perturbations will have a duration of 200 ms, and will be applied immediately after onset of the swing phase with either the paretic or non-paretic leg. If in a given training session, a participant does not experience any losses of balance, the perturbation magnitude will be increased in the next training session. Perturbations will begin at 3% body weight (BW), and will progress in increments of 3% BW up to a maximum of 15% BW. The structure of the Reactive perturbation session will be identical to that used for Proactive perturbation training sessions, including overground trials, treadmill trials without perturbations, and Perturbed and Catch trials in which Perturbations are delivered. | Behavioural | Reactive Perturbations |
| Proactive PerturbationsA novel device will be used to perturb the relationship between pelvis motion and step width by applying mediolateral forces to participants' legs. Participants will first perform a 3-minute overground walking trial at their self-selected speed, in which they do not interact with the perturbation device. Participants will then perform a 3-minute treadmill walking trial at their self-selected speed, in which they again do not interact with the perturbation device. Participants will then perform a series of alternating 3-minute Perturbed and Catch trials, all at their self-selected speed. For the Perturbed trials, perturbations will be delivered in each step throughout the trial. For the Catch trials, perturbations will cease for the final minute of walking. A total of 5 Perturbed and 5 Catch trials will be performed. Finally, participants will perform a 3-minute overground walking trial at their self-selected speed, in which they do not interact with the perturbation device. | Behavioural | Proactive Perturbations |
Primary outcome
Fall incidence
Time frame: 32 weeks (12-week period pre-intervention; 12-week period post-intervention)
A fall will be defined as an event in which a participant loses their balance and comes to rest on the ground, floor, or lower level. Falls will be measured during the 12-week periods preceding and following the intervention, using 2-week calendars on postcards to be sent to the investigators.
14 secondary outcomes
Fear of falling
Time frame: 8 weeks (pre-intervention; post-intervention)
Functional Gait Assessment
Time frame: 8 weeks (pre-intervention; post-intervention)
Activities-specific Balance Confidence scale
Time frame: 8 weeks (pre-intervention; post-intervention)
Walking speed
Time frame: 8 weeks (pre-intervention; post-intervention)
Foot placement stabilization strategy (mechanics)
Time frame: 8 weeks (pre-intervention; post-intervention)
Foot placement stabilization strategy (gluteus medius activity)
Time frame: 8 weeks (pre-intervention; post-intervention)
Center of pressure shift stabilization strategy (mechanics)
Time frame: 8 weeks (pre-intervention; post-intervention)
Center of pressure shift stabilization strategy (peroneus longus activity)
Time frame: 8 weeks (pre-intervention; post-intervention)
Push-off stabilization strategy (mechanics)
Time frame: 8 weeks (pre-intervention; post-intervention)
Push-off stabilization strategy (medial gastrocnemius activity)
Time frame: 8 weeks (pre-intervention; post-intervention)
Largest rejected perturbation (trained perturbations) Largest rejected perturbation (trunk)
Time frame: 8 weeks (pre-intervention; post-intervention)
Largest rejected perturbation (untrained perturbations) Largest rejected perturbation (trunk)
Time frame: 8 weeks (pre-intervention; post-intervention)
Angular momentum modulation (trained perturbations) Largest rejected perturbation (trunk)
Time frame: 8 weeks (pre-intervention; post-intervention)
Angular momentum modulation (untrained perturbations) Largest rejected perturbation (trunk)
Time frame: 8 weeks (pre-intervention; post-intervention)
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 28 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified participant data consisting of the clinical assessments and biomechanical walking data collected in this study will be shared through the IPCSR website.
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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.
Jesse Dean principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reactive Perturbations and Proactive Perturbations in people with Stroke, run by Medical University of South Carolina 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 8 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 28 Jul 2026. 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?
Fall incidence (time frame: 32 weeks (12-week period pre-intervention; 12-week period post-intervention)). 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 28 Jul 2026.