StrokeNCT04947865
Reflex Excitability in Post-stroke Stiff-Knee Gait
A study testing Peripheral nerve stimulation and Commercial knee brace in people with Stroke and Chronic Stroke, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the reflex excitability of the rectus femoris in individuals with and without post-stroke Stiff-Knee gait. We use electrical stimulation of the peripheral nerve innervating the rectus femoris for a well-controlled reflex stimulus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Chronic Stroke, Gait, Hemiplegic
- What is being tested?
- Peripheral nerve stimulation and Commercial knee brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2021to 29 Jul 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged at least 18
- Premorbidly independent
- If post-stroke, mild to moderate impairment determined by standard practices per the physical therapist
- Able to continuously walk for 30 minutes
- If post-stroke, reduced knee flexion during walking relative to unimpaired side
- If post-stroke, hemiparesis
- Ability to provide informed consent
Who cannot join
- No history of serious lower limb musculoskeletal injury
- No functionally relevant osteoarthritis and weight-bearing restrictions
- No functionally relevant polyneuropathy
- No functionally relevant cognitive impairment
- No functionally relevant vision impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Abnormal Reflex Couplings Via H-reflex Stimulation
The purpose of this study is to examine the reflex excitability of the rectus femoris in individuals with and without post-stroke Stiff-Knee gait. We use electrical stimulation of the peripheral nerve innervating the rectus femoris for a well-controlled reflex stimulus. We are investigating whether reflex excitability of the rectus femoris correlates with gait kinematics.
Read the detailed description
The purpose of this study is to investigate the role of hyperreflexia in post-stroke Stiff-Knee gait function. In one aim,
- Conditions
- Stroke, Chronic Stroke, Gait, Hemiplegic, Gait, Spastic, Gait Disorder, Sensorimotor, Gait Disorders, Neurologic
- Being tested
- Peripheral nerve stimulation, Commercial knee brace
- Medical subject headings
- Stroke, Gait Disorders, Neurologic, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral nerve stimulationOther
Electrical stimulation of peripheral nerves to measure resulting gait kinematics and surface muscle activity
Commercial knee braceDevice
Knee brace used to limit knee mobility in healthy individuals to imitate stroke survivors and measure resulting gait kinematics and surface muscle activity.
| Study group | Role | What they receive |
|---|---|---|
| Post-stroke Stiff-Knee Gait Participants | Experimental | Individuals with post-stroke Stiff-Knee gait Receives: Other: Peripheral nerve stimulation |
| Healthy Individuals | Experimental | Healthy Individuals Receives: Other: Peripheral nerve stimulation; Device: Commercial knee brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface electromyographic recording of leg muscles during different conditions
Recording electrical activity of leg muscles during walking in response to peripheral nerve stimulation
Measured: 1 hour
Secondary outcomes (1)
Circumduction measure
Hip abduction joint motion measured with motion capture
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start11 Jun 2021
- Primary completion11 Jun 2025
- Study completion29 Jul 2026
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
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, James Sulzer, MetroHealth Medical Center
- Investigators
- James S Sulzer, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947865
- Sponsor's protocol ID
- 2017-01-0022
- Other IDs
- R01HD100416
- Status last verified
- Sep 2026
- First submitted
- 11 Jun 2021
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Abnormal Reflex Couplings Via H-reflex Stimulation
- ClinicalTrials.gov ID
- NCT04947865
- Acronym / sponsor ID
- 2017-01-0022
- Conditions
- Stroke, Chronic Stroke, Gait, Hemiplegic, Gait, Spastic, Gait Disorder, Sensorimotor, Gait Disorders, Neurologic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 1 Jul 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.
The purpose of this study is to examine the reflex excitability of the rectus femoris in individuals with and without post-stroke Stiff-Knee gait. We use electrical stimulation of the peripheral nerve innervating the rectus femoris for a well-controlled reflex stimulus. We are investigating whether reflex excitability of the rectus femoris correlates with gait kinematics.
Detailed description
The purpose of this study is to investigate the role of hyperreflexia in post-stroke Stiff-Knee gait function. In one aim,
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-stroke Stiff-Knee Gait Participants | Experimental | Other: Peripheral nerve stimulationIndividuals with post-stroke Stiff-Knee gait |
| Healthy Individuals | Experimental | Other: Peripheral nerve stimulation, Device: Commercial knee braceHealthy Individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged at least 18
- Premorbidly independent
- If post-stroke, mild to moderate impairment determined by standard practices per the physical therapist
- Able to continuously walk for 30 minutes
- If post-stroke, reduced knee flexion during walking relative to unimpaired side
Key exclusion criteria (5 listed)
- No history of serious lower limb musculoskeletal injury
- No functionally relevant osteoarthritis and weight-bearing restrictions
- No functionally relevant polyneuropathy
- No functionally relevant cognitive impairment
- No functionally relevant vision 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 |
|---|---|---|
| Peripheral nerve stimulationElectrical stimulation of peripheral nerves to measure resulting gait kinematics and surface muscle activity | Other | Healthy Individuals, Post-stroke Stiff-Knee Gait Participants |
| Commercial knee braceKnee brace used to limit knee mobility in healthy individuals to imitate stroke survivors and measure resulting gait kinematics and surface muscle activity. | Device | Healthy Individuals |
Primary outcome
Surface electromyographic recording of leg muscles during different conditions
Time frame: 1 hour
Recording electrical activity of leg muscles during walking in response to peripheral nerve stimulation
1 secondary outcome
Circumduction measure
Time frame: 1 hour
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 4 Sep 2026.
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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.
James S Sulzer principal investigator
Case Western Reserve 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 Peripheral nerve stimulation and Commercial knee brace in people with Stroke and Chronic Stroke, run by MetroHealth Medical Center 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 7 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 4 Sep 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?
Surface electromyographic recording of leg muscles during different conditions (time frame: 1 hour). 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 4 Sep 2026.