Trial Outcomes & Findings for Operant H-reflex Down-conditioning of Rectus Femoris in Post-stroke Stiff Knee Gait (NCT NCT05467774)
NCT ID: NCT05467774
Last Updated: 2024-07-16
Results Overview
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.
COMPLETED
EARLY_PHASE1
7 participants
3 months
2024-07-16
Participant Flow
There were no other factors considered in addition to already stated inclusion/exclusion criteria
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Operant H-reflex Down-conditioning of Rectus Femoris in Post-stroke Stiff Knee Gait
Baseline characteristics by cohort
| Measure |
Training Group
n=7 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 19.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 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.
Outcome measures
| Measure |
Training Group
n=7 Participants
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
|
|---|---|
|
Percentage Change From Baseline in RF H-reflex Magnitude
|
-43.82 percentage change in reflex size
Standard Error 4.81
|
SECONDARY outcome
Timeframe: 3 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.
Outcome measures
| Measure |
Training Group
n=7 Participants
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
|
|---|---|
|
Percentage Change From Baseline in VM H-reflex Magnitude
|
-49.16 percentage change in reflex size
Standard Error 5.42
|
Adverse Events
Training Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. James Sulzer
MetroHealth Hospital/Case Western Reserve University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place