Reflex Excitability in Post-stroke Stiff-Knee Gait

December 17, 2025 updated by: James Sulzer, MetroHealth Medical Center

Characterization of Abnormal Reflex Couplings Via H-reflex Stimulation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Post-stroke Stiff-Knee Gait Participants
Individuals with post-stroke Stiff-Knee gait
Other: Peripheral nerve stimulation
Electrical stimulation of peripheral nerves to measure resulting gait kinematics and surface muscle activity
Experimental: Healthy Individuals
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface electromyographic recording of leg muscles during different conditions
Time Frame: 1 hour
Recording electrical activity of leg muscles during walking in response to peripheral nerve stimulation
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circumduction measure
Time Frame: 1 hour
Hip abduction joint motion measured with motion capture
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: James S Sulzer, Case Western Reserve University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2021

Primary Completion (Actual)

June 11, 2025

Study Completion (Estimated)

June 11, 2026

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 23, 2021

First Posted (Actual)

July 1, 2021

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01-0022
  • R01HD100416 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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