Reflex Excitability in Post-stroke Stiff-Knee Gait

Stroke Clinical Trial

Official title:

Characterization of Abnormal Reflex Couplings Via H-reflex Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04947865
• Other study ID #: 2017-01-0022
• Secondary ID: R01HD100416
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2021
• Est. completion date: June 11, 2026

Study information

• Verified date: April 2024
• Source: MetroHealth Medical Center
• Contact: James Sulzer, PhD
• Phone: 5125419036
• Email: jss280[@]case.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the reflex excitability of the rectus femoris in individuals with and without post-stroke Stiff-Knee gait. We use electrical stimulation of the peripheral nerve innervating the rectus femoris for a well-controlled reflex stimulus. We are investigating whether reflex excitability of the rectus femoris correlates with gait kinematics.

Description:

The purpose of this study is to investigate the role of hyperreflexia in post-stroke Stiff-Knee gait function. In one aim,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 11, 2026
• Est. primary completion date: June 11, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Aged at least 18

• Premorbidly independent

• If post-stroke, mild to moderate impairment determined by standard practices per the physical therapist

• Able to continuously walk for 30 minutes

• If post-stroke, reduced knee flexion during walking relative to unimpaired side

• If post-stroke, hemiparesis

• Ability to provide informed consent

Exclusion criteria:

• No history of serious lower limb musculoskeletal injury

• No functionally relevant osteoarthritis and weight-bearing restrictions

• No functionally relevant polyneuropathy

• No functionally relevant cognitive impairment

• No functionally relevant vision impairment

Related Conditions & MeSH terms

• Chronic Stroke
• Gait Disorder, Sensorimotor
• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Gait, Spastic
• Mobility Limitation
• Nervous System Diseases
• Stroke
• Walking, Difficulty

Intervention

Other:
• Peripheral nerve stimulation
Electrical stimulation of peripheral nerves to measure resulting gait kinematics and surface muscle activity

Device:
• Commercial knee brace
Knee brace used to limit knee mobility in healthy individuals to imitate stroke survivors and measure resulting gait kinematics and surface muscle activity.

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
MetroHealth Medical Center	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	Surface electromyographic recording of leg muscles during different conditions	Recording electrical activity of leg muscles during walking in response to peripheral nerve stimulation	1 hour
Secondary	Circumduction measure	Hip abduction joint motion measured with motion capture	1 hour