Reflex Excitability in Post-stroke Stiff-Knee Gait

NCT04947865 | Active Not Recruiting FDA Device

• 2 other identifiers: 2017-01-0022R01HD100416
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Chronic Stroke; Gait, Spastic; Gait, Hemiplegic; Gait Disorder, Sensorimotor; Gait Disorders, Neurologic; Walking, Difficulty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Circumduction measure

  1 hour

Study Arms (2)

Post-stroke Stiff-Knee Gait Participants

EXPERIMENTAL

Individuals with post-stroke Stiff-Knee gait

Other: Peripheral nerve stimulation

Healthy Individuals

EXPERIMENTAL

Healthy Individuals

Other: Peripheral nerve stimulation; Device: Commercial knee brace

Interventions

Peripheral nerve stimulation OTHER

Electrical stimulation of peripheral nerves to measure resulting gait kinematics and surface muscle activity

Healthy Individuals; Post-stroke Stiff-Knee Gait Participants

Commercial knee brace DEVICE

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

Healthy Individuals

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic; Mobility Limitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James S Sulzer

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 1, 2021
• Study Start: June 11, 2021
• Primary Completion: June 11, 2025
• Study Completion (Estimated): June 11, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-09

Locations

US (1)