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Clinical Trials/NCT05467774
NCT05467774
Completed
Early Phase 1

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

University of Texas at Austin1 site in 1 country7 target enrollmentJuly 28, 2018
ConditionsTraining

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Training
Sponsor
University of Texas at Austin
Enrollment
7
Locations
1
Primary Endpoint
Percentage Change From Baseline in RF H-reflex Magnitude
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 28, 2018
End Date
February 17, 2020
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Percentage Change From Baseline in VM H-reflex Magnitude(3 months)

Study Sites (1)

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