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

NCT05467774 | Completed Early Phase 1 Results

• 2 other identifiers: 2018030053R01HD100416
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Training

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• Percentage Change From Baseline in VM H-reflex Magnitude

  3 months

Study Arms (1)

Training group

EXPERIMENTAL

Participants receive 24 sessions of operant H-reflex conditioning of the rectus femoris.

Behavioral: Operant RF H-reflex conditioning

Interventions

Operant RF H-reflex conditioning BEHAVIORAL

Operant down-conditioning of rectus femoris H-reflex

Training group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Results Point of Contact

• Title: Dr. James Sulzer
• Organization: MetroHealth Hospital/Case Western Reserve University

jss280@case.edu

5125419036

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 21, 2022
• Study Start: July 28, 2018
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: July 16, 2024
• Results First Posted: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 3 years

Locations

US (1)