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Operant H-reflex Down-conditioning of Rectus Femoris in Post-stroke Stiff Knee Gait

Operant H-reflex Down-conditioning of Rectus Femoris in Post-stroke Stiff Knee Gait

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05467774
Enrollment
7
Registered
2022-07-21
Start date
2018-07-28
Completion date
2020-02-17
Last updated
2024-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Training

Brief 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.

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.

Interventions

BEHAVIORALOperant RF H-reflex conditioning

Operant down-conditioning of rectus femoris H-reflex

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * Took antispasmodic medication one day prior to the session * Had Botox injection one week prior to the session * Pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Percentage Change From Baseline in RF H-reflex Magnitude3 monthsH-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.

Secondary

MeasureTime frameDescription
Percentage Change From Baseline in VM H-reflex Magnitude3 monthsH-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.

Countries

United States

Participant flow

Pre-assignment details

There were no other factors considered in addition to already stated inclusion/exclusion criteria

Participants by arm

ArmCount
Training Group
Participants receive 24 sessions of operant H-reflex conditioning of the rectus femoris. Operant RF H-reflex conditioning: Operant down-conditioning of rectus femoris H-reflex
7
Total7

Baseline characteristics

CharacteristicTraining Group
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
Age, Continuous33.4 years
STANDARD_DEVIATION 19.4
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
6 Participants
Region of Enrollment
United States
7 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
3 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 7
other
Total, other adverse events
0 / 7
serious
Total, serious adverse events
0 / 7

Outcome results

Primary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Training GroupPercentage Change From Baseline in RF H-reflex Magnitude-43.82 percentage change in reflex sizeStandard Error 4.81
Secondary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Training GroupPercentage Change From Baseline in VM H-reflex Magnitude-49.16 percentage change in reflex sizeStandard Error 5.42

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026