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

Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05467774
• Other study ID #: 2018030053
• Secondary ID: R01HD100416
• Status: Completed
• Phase: Early Phase 1
• Start date: July 28, 2018
• Est. completion date: February 17, 2020

Study information

• Verified date: November 2023
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 17, 2020
• Est. primary completion date: February 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Training

Intervention

Behavioral:
• Operant RF H-reflex conditioning
Operant down-conditioning of rectus femoris H-reflex

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RF H-reflex magnitude	H-reflex magnitude of rectus femoris	3 months
Secondary	VM H-reflex magnitude	H-reflex magnitude of vastus medialis	3 months