StrokeNCT06034119
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
A study testing Split belt treadmill and Biofeedback in people with Stroke, run by Chapman University at 1 site in United States.
Trial summary
People post-stroke retain the capacity to modify walking patterns explicitly using biofeedback and implicitly when encountering changes in the walking environment. This proposal will assess changes in muscle activation patterns associated with walking modifications driven explicitly vs. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Split belt treadmill and Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2023to 30 Jun 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic hemiparesis (time since stroke > 6 months) caused by a single documented stroke event.
- Ability to walk on the treadmill continuously for 2 minutes
- Ability to walk over ground independently or with the use of a cane
- No concurrent neurological disorders or orthopedic conditions that interfere with their ability to walk
- No prior experience walking on a split-belt treadmill
- Normal or corrected to normal vision
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- The ability for them or a guardian to provide informed consent.
- No musculoskeletal conditions or injuries that limit walking ability within the last two years
- No history of neurological disorders or severe head trauma
- No prior experience walking on a split-belt treadmill
- Normal or corrected to normal vision.
Who cannot join
- Inability to walk
- Concurrent neurological disorders or orthopedic conditions that interfere with their ability to walk
- More than one stroke
- Visual neglect
- Uncontrolled hypertension
- Inability to provide informed consent.
Show all 10Show fewer
- Inability to walk
- Concurrent neurological disorders or orthopedic conditions that interfere with their ability to walk
- Uncontrolled hypertension
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Effects of Increased Demands for Voluntary Adjustments on the Neuromuscular Control of Walking Post-stroke
People post-stroke retain the capacity to modify walking patterns explicitly using biofeedback and implicitly when encountering changes in the walking environment. This proposal will assess changes in muscle activation patterns associated with walking modifications driven explicitly vs. implicitly, to determine whether individuals generate different amounts of co-contraction during explicit vs. implicit walking modifications. Understanding how walking modifications driven explicitly vs. implicitly influence co-contraction will allow the investigators to identify approaches that can more effectively restore muscle activation toward pre-stroke patterns, promoting mechanism-based recovery of walking function.
Read the detailed description
This proposal aims to determine the effects of explicitly driven or implicitly driven walking modifications on muscle activation patterns and co-contraction post-stroke. This work is significant, as studies have shown that muscle activation patterns after neurologic injury cannot generate walking kinematics comparable to those seen in neurotypical individuals; this finding implies that to attain true walking recovery after neurologic injury, interventions should aim to restore the muscle activations underlying walking behaviors. Here, the researchers first explore muscle activations during walking using biofeedback to guide explicit modification of walking patterns, which is a common approach used in clinical and research interventions for walking retraining. The hypothesis is that explicit walking modifications might be detrimental at a muscle activation level as they engage cortical pathways for voluntary control that have been interrupted by the stroke lesion, resulting in increased muscle co-contraction. Co-contraction hinders true recovery as it impairs the ability to selectively control different segments during walking, resulting in overreliance on compensatory patterns. Researchers will also explore muscle activation patterns during implicit walking modifications. Researchers will use external modifications in the walking environment, mainly split-belt adaptation followed by tied belt walking, to assess if implicit modifications of walking that rely less on cortical neural control are associated with levels of cocontraction comparable to neurotypical controls-an indication that implicitly-mediated modifications could be a more effective approach to restore muscle activation patterns during walking post-stroke. In this study, researchers will assess co-contraction during walking in people post-stroke as the patient reduces asymmetry in step lengths guided by explicit biofeedback (Aim 1) or implicitly following split-belt adaptation and washout (Aim 2). Results from this study will identify the tasks and conditions that can reduce cocontraction to promote restoration of neuromuscular control post-stroke. This proposal will aid develop objective markers of treatment response and functional progress that predict rehabilitation treatment response and enable the tailoring of interventions to the needs, abilities, and resources of the person with disability.
- Conditions
- Stroke
- Being tested
- Split belt treadmill, Biofeedback
- Keywords
- Walking, Gait, Motor control, Neurorehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split belt treadmillBehavioural
Participants will walk on a dual belt treadmill with each belt moving at a different speed which is known as a split belt treadmill to provide implicit modifications of the walking pattern
BiofeedbackBehavioural
The Gait Real-time Analysis Interactive Lab (GRAIL) system has an immersive virtual reality screen that provides real-time information to participants of their walking pattern and provides visual instructions on how to walk more symmetrically
| Study group | Role | What they receive |
|---|---|---|
| Stroke participants | Experimental | Researchers will assess muscle control in participants post-stroke during different types of walking modifications Receives: Behavioral: Split belt treadmill; Behavioral: Biofeedback |
| Neurotypical participants | Active comparator | Researchers will compare muscle control to neurotypical participants during the same types of walking modifications to assess stroke-induced changes in muscle control vs. intervention-induced changes in muscle control Receives: Behavioral: Split belt treadmill; Behavioral: Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAF1 - variance accounted for in a single muscle activation module
Using non-negative matrix factorization researchers will evaluate the coordinated co-activation of muscles during walking. If muscles are more co-activated, a single module will account for more variance in muscle activation data. For impaired muscle control, VAF1 will be closer to 1, for better muscle control, VAF1 will be closer to 0.
Measured: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
walkDMC - walking Dynamic Motor Control Index
variance accounted for by a single module relative to control participants. A value greater than 1 indicates impaired control relative to controls
Measured: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Secondary outcomes (5)
Muscle activation modules
To compare results to previous studies assessing neuromuscular control, researchers will identify in each individual the number of muscle activation modules that account for 90% of the variance in muscle activation data. More modules indicates the ability to control muscles independently and therefore less impairment
Measured: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Compensation measures - hip hiking
To determine whether explicit and implicit adjustments lead individuals to increase hip hiking, which is an increase in the non-pareteic coronal hip and/or pelvic angle when the affected limb is in midswing. Hip hiking is a strategy used to compensate for the insufficient flexion of the hip joint during the swing phase, as well as knee flexion and ankle dorsiflexion, thus shortening the paretic limb. Measured in degrees
Measured: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Compensation measures - hip circumduction
To determine whether explicit and implicit adjustments lead individuals to increase hip circumduction, in which the patient abducts their thigh and swings their leg in a semi-circle to attain adequate clearance during swing. Measured in degrees
Measured: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Compensation measures - overreliance on the non-paretic extremity to generate propulsion
The paretic limb's contribution to forward propulsion. Defined as calculated as a ratio of the paretic limb's propulsive force divided by the sum of the paretic and non-paretic limb's force. Measured as a percentage.
Measured: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Compensation measures - step width
The distance between both feet during the double support phase of gait. Measured in millimeters
Measured: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start7 Sep 2023
- Primary completion27 Jun 2025
- Study completion30 Jun 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A group of participants post-stroke and neurotypical controls will be recruited for this study. All individuals will perform all conditions
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chapman University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034119
- Sponsor's protocol ID
- IRB-23-57
- Other IDs
- 1R03HD107630-01A1
- Status last verified
- Sep 2025
- First submitted
- 26 Jul 2023
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Principal Investigator, is the leader of the Stroke Initiative for Gait Data Evaluation (STRIDE) database, available at The Archive of Data on Disability to Enable Policy and research (ADDEP, https://www.icpsr.umich.edu/web/pages/ADDEP/), a joint initiative of the Center for Large Data Research and Data Sharing in Rehabilitation (CLDR). ADDEP is supported by grant P2CHD065702 awarded to the CLDR by the NIH - National Institute of Child Health and Human Development, through the National Center for Medical Rehabilitation Research, the National Institute for Neurological Disorders and Stroke, and the National Institute of Biomedical Imaging and Bioengineering. The investigators will request to share the data for the present study in STRIDE. The investigators will share walking kinematic and EMG data. No identifiable information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effects of Increased Demands for Voluntary Adjustments on the Neuromuscular Control of Walking Post-stroke
- ClinicalTrials.gov ID
- NCT06034119
- Acronym / sponsor ID
- IRB-23-57
- Conditions
- Stroke
- Keywords
- Walking, Gait, Motor control, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Chapman UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 13 Sep 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.
People post-stroke retain the capacity to modify walking patterns explicitly using biofeedback and implicitly when encountering changes in the walking environment. This proposal will assess changes in muscle activation patterns associated with walking modifications driven explicitly vs. implicitly, to determine whether individuals generate different amounts of co-contraction during explicit vs. implicit walking modifications. Understanding how walking modifications driven explicitly vs. implicitly influence co-contraction will allow the investigators to identify approaches that can more effectively restore muscle activation toward pre-stroke patterns, promoting mechanism-based recovery of walking function.
Detailed description
This proposal aims to determine the effects of explicitly driven or implicitly driven walking modifications on muscle activation patterns and co-contraction post-stroke. This work is significant, as studies have shown that muscle activation patterns after neurologic injury cannot generate walking kinematics comparable to those seen in neurotypical individuals; this finding implies that to attain true walking recovery after neurologic injury, interventions should aim to restore the muscle activations underlying walking behaviors. Here, the researchers first explore muscle activations during walking using biofeedback to guide explicit modification of walking patterns, which is a common approach used in clinical and research interventions for walking retraining. The hypothesis is that explicit walking modifications might be detrimental at a muscle activation level as they engage cortical pathways for voluntary control that have been interrupted by the stroke lesion, resulting in increased muscle co-contraction. Co-contraction hinders true recovery as it impairs the ability to selectively control different segments during walking, resulting in overreliance on compensatory patterns. Researchers will also explore muscle activation patterns during implicit walking modifications. Researchers will use external modifications in the walking environment, mainly split-belt adaptation followed by tied belt walking, to assess if implicit modifications of walking that rely less on cortical neural control are associated with levels of cocontraction comparable to neurotypical controls-an indication that implicitly-mediated modifications could be a more effective approach to restore muscle activation patterns during walking post-stroke. In this study, researchers will assess co-contraction during walking in people post-stroke as the patient reduces asymmetry in step lengths guided by explicit biofeedback (Aim 1) or implicitly following split-belt adaptation and washout (Aim 2). Results from this study will identify the tasks and conditions that can reduce cocontraction to promote restoration of neuromuscular control post-stroke. This proposal will aid develop objective markers of treatment response and functional progress that predict rehabilitation treatment response and enable the tailoring of interventions to the needs, abilities, and resources of the person with disability.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A group of participants post-stroke and neurotypical controls will be recruited for this study. All individuals will perform all conditions
| Arm | Type | Receives |
|---|---|---|
| Stroke participants | Experimental | Behavioral: Split belt treadmill, Behavioral: BiofeedbackResearchers will assess muscle control in participants post-stroke during different types of walking modifications |
| Neurotypical participants | Active comparator | Behavioral: Split belt treadmill, Behavioral: BiofeedbackResearchers will compare muscle control to neurotypical participants during the same types of walking modifications to assess stroke-induced changes in muscle control vs. intervention-induced changes in muscle control |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Chronic hemiparesis (time since stroke > 6 months) caused by a single documented stroke event.
- Ability to walk on the treadmill continuously for 2 minutes
- Ability to walk over ground independently or with the use of a cane
- No concurrent neurological disorders or orthopedic conditions that interfere with their ability to walk
- No prior experience walking on a split-belt treadmill
Key exclusion criteria (10 listed)
- Inability to walk
- Concurrent neurological disorders or orthopedic conditions that interfere with their ability to walk
- More than one stroke
- Visual neglect
- Uncontrolled hypertension
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 |
|---|---|---|
| Split belt treadmillParticipants will walk on a dual belt treadmill with each belt moving at a different speed which is known as a split belt treadmill to provide implicit modifications of the walking pattern | Behavioural | Neurotypical participants, Stroke participants |
| BiofeedbackThe Gait Real-time Analysis Interactive Lab (GRAIL) system has an immersive virtual reality screen that provides real-time information to participants of their walking pattern and provides visual instructions on how to walk more symmetrically | Behavioural | Neurotypical participants, Stroke participants |
Primary outcome
VAF1 - variance accounted for in a single muscle activation module
Time frame: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Using non-negative matrix factorization researchers will evaluate the coordinated co-activation of muscles during walking. If muscles are more co-activated, a single module will account for more variance in muscle activation data. For impaired muscle control, VAF1 will be closer to 1, for better muscle control, VAF1 will be closer to 0.
walkDMC - walking Dynamic Motor Control Index
Time frame: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
variance accounted for by a single module relative to control participants. A value greater than 1 indicates impaired control relative to controls
5 secondary outcomes
Muscle activation modules
Time frame: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Compensation measures - hip hiking
Time frame: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Compensation measures - hip circumduction
Time frame: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Compensation measures - overreliance on the non-paretic extremity to generate propulsion
Time frame: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Compensation measures - step width
Time frame: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
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 25 Sep 2025.
- Individual participant dataSharing planned: No. The Principal Investigator, is the leader of the Stroke Initiative for Gait Data Evaluation (STRIDE) database, available at The Archive of Data on Disability to Enable Policy and research (ADDEP, https://www.icpsr.umich.edu/web/pages/ADDEP/), a joint initiative of the Center for Large Data Research and Data Sharing in Rehabilitation (CLDR). ADDEP is supported by grant P2CHD065702 awarded to the CLDR by the NIH - National Institute of Child Health and Human Development, through the National Center for Medical Rehabilitation Research, the National Institute for Neurological Disorders and Stroke, and the National Institute of Biomedical Imaging and Bioengineering. The investigators will request to share the data for the present study in STRIDE. The investigators will share walking kinematic and EMG data. No identifiable information will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split belt treadmill and Biofeedback in people with Stroke, run by Chapman 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 11 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 25 Sep 2025. 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?
VAF1 - variance accounted for in a single muscle activation module (time frame: Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing). The study lists 2 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 25 Sep 2025.