TrainingEarly Phase 1NCT05467774
Operant H-reflex Down-conditioning of Rectus Femoris in Post-stroke Stiff Knee Gait
A Early Phase 1 study testing Operant RF H-reflex conditioning in people with Training, run by University of Texas at Austin at 1 site in United States.
Trial summary
The investigators performed a feasibility trial of operant conditioning of spinal reflex excitability on five healthy individuals and two post-stroke individuals. The investigators found that operant conditioning of rectus femoris reflex excitability was feasible in all participants. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Training
- What is being tested?
- Operant RF H-reflex conditioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2018to 17 Feb 2020
- Phase
- Early Phase 1
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Premorbidly independent
- Mild to moderate impairment determined by standard practices per the physical therapist
- Ability to stand for 10-minute intervals unassisted
- Ability to walk for 10-minutes on a treadmill
- Reduced knee flexion during phase and SKG as determined by a clinician
- Hemiparesis
- Ability to provide informed consent
Who cannot join
- History of cerebellar stroke, multiple stroke
- History of serious lower limb musculoskeletal injury
- Functionally relevant osteoarthritis and weight-bearing restrictions
- Have condition related to claustrophobia or other MRI contraindications
- Functionally relevant cognitive impairment
- Functionally relevant vision impairment
Show all 9Show fewer
- Took antispasmodic medication one day prior to the session
- Had Botox injection one week prior to the session
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
The investigators performed a feasibility trial of operant conditioning of spinal reflex excitability on five healthy individuals and two post-stroke individuals. The investigators found that operant conditioning of rectus femoris reflex excitability was feasible in all participants.
Read the detailed description
The investigators performed a cohort study on 7 individuals (5 healthy, 2 post-stroke) to examine the feasibility of operant down-conditioning of rectus femoris reflex excitability (i.e. H-reflex). Each individual performed 30 sessions, 6 baseline sessions with no operant conditioning (225 trials of surface electrical stimulation of the femoral nerve), followed by 24 training sessions (20 baseline trials followed by 225 trials with feedback of H-reflex magnitude). The investigators' main outcome measure was rectus femoris H-reflex magnitude. We also examined H-reflex magnitude of other quadriceps muscles.
- Conditions
- Training
- Being tested
- Operant RF H-reflex conditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operant RF H-reflex conditioningBehavioural
Operant down-conditioning of rectus femoris H-reflex
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Participants receive 24 sessions of operant H-reflex conditioning of the rectus femoris. Receives: Behavioral: Operant RF H-reflex conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in RF H-reflex Magnitude
H-reflex magnitude of rectus femoris. Lower values are considered better. The H-reflex is the amplitude of the monosynaptic spinal reflex, elicitied by electrical stimulation of the femoral nerve, normalized by the preceding M-wave. The M-wave is the amplitude of the muscle activity response to surface electrical stimulation of the femoral nerve. All muscle activity measured at the individual's rectus femoris of the stimulated limb. A value of 100% would mean no change in reflex magnitude, whereas a change of -20%, for instance, would mean a 20% drop in reflex magnitude over the 3 month training period.
Measured: 3 months
Secondary outcomes (1)
Percentage Change From Baseline in VM H-reflex Magnitude
H-reflex magnitude of vastus medialis. Lower values are considered better. The H-reflex is the amplitude of the monosynaptic spinal reflex, elicitied by electrical stimulation of the femoral nerve, normalized by the preceding M-wave. The M-wave is the amplitude of the muscle activity response to surface electrical stimulation of the femoral nerve. All muscle activity measured at the individual's vastus medialis of the stimulated limb. A value of 100% would mean no change in reflex magnitude, whereas a change of -20%, for instance, would mean a 20% drop in reflex magnitude over the 3 month training period.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start28 Jul 2018
- Primary completion17 Feb 2020
- Study completion17 Feb 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.
- Other trials for TrainingStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- 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
- NCT05467774
- Sponsor's protocol ID
- 2018030053
- Other IDs
- R01HD100416
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2022
- Last updated
- 16 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unidentified data available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operant H-reflex Down-conditioning of Rectus Femoris in Post-stroke Stiff Knee Gait
- ClinicalTrials.gov ID
- NCT05467774
- Acronym / sponsor ID
- 2018030053
- Conditions
- Training
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 Jul 2018 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Posted 16 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators performed a feasibility trial of operant conditioning of spinal reflex excitability on five healthy individuals and two post-stroke individuals. The investigators found that operant conditioning of rectus femoris reflex excitability was feasible in all participants.
Detailed description
The investigators performed a cohort study on 7 individuals (5 healthy, 2 post-stroke) to examine the feasibility of operant down-conditioning of rectus femoris reflex excitability (i.e. H-reflex). Each individual performed 30 sessions, 6 baseline sessions with no operant conditioning (225 trials of surface electrical stimulation of the femoral nerve), followed by 24 training sessions (20 baseline trials followed by 225 trials with feedback of H-reflex magnitude). The investigators' main outcome measure was rectus femoris H-reflex magnitude. We also examined H-reflex magnitude of other quadriceps muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Behavioral: Operant RF H-reflex conditioningParticipants receive 24 sessions of operant H-reflex conditioning of the rectus femoris. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Premorbidly independent
- Mild to moderate impairment determined by standard practices per the physical therapist
- Ability to stand for 10-minute intervals unassisted
- Ability to walk for 10-minutes on a treadmill
- Reduced knee flexion during phase and SKG as determined by a clinician
Key exclusion criteria (9 listed)
- History of cerebellar stroke, multiple stroke
- History of serious lower limb musculoskeletal injury
- Functionally relevant osteoarthritis and weight-bearing restrictions
- Have condition related to claustrophobia or other MRI contraindications
- Functionally relevant cognitive 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 |
|---|---|---|
| Operant RF H-reflex conditioningOperant down-conditioning of rectus femoris H-reflex | Behavioural | Training group |
Primary outcome
Percentage Change From Baseline in RF H-reflex Magnitude
Time frame: 3 months
H-reflex magnitude of rectus femoris. Lower values are considered better. The H-reflex is the amplitude of the monosynaptic spinal reflex, elicitied by electrical stimulation of the femoral nerve, normalized by the preceding M-wave. The M-wave is the amplitude of the muscle activity response to surface electrical stimulation of the femoral nerve. All muscle activity measured at the individual's rectus femoris of the stimulated limb. A value of 100% would mean no change in reflex magnitude, whereas a change of -20%, for instance, would mean a 20% drop in reflex magnitude over the 3 month training period.
1 secondary outcome
Percentage Change From Baseline in VM H-reflex Magnitude
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Unidentified data available upon reasonable request
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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 Early Phase 1 study testing Operant RF H-reflex conditioning in people with Training, run by University of Texas at Austin 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 9 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 16 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2024). 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?
Percentage Change From Baseline in RF H-reflex Magnitude (time frame: 3 months). 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 16 Jul 2024.