Early Phase 1
N=7
Operant H-reflex Down-conditioning of Rectus Femoris in Post-stroke Stiff Knee Gait
Training
Bottom Line
View on ClinicalTrials.gov: NCT05467774 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Percentage Change From Baseline in RF H-reflex Magnitude — -43.82 percentage change in reflex size
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Operant RF H-reflex conditioning (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas at Austin
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in RF H-reflex Magnitude |
-43.82 | — |
| SECONDARY Percentage Change From Baseline in VM H-reflex Magnitude |
-49.16 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05467774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.