Reflex Excitability in Post-stroke Stiff-Knee Gait

NCT ID: NCT04947865

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-11

Study Completion Date

2026-06-11

Brief Summary

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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.

Detailed Description

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

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Post-stroke Stiff-Knee Gait Participants

Individuals with post-stroke Stiff-Knee gait

Group Type EXPERIMENTAL

Peripheral nerve stimulation

Intervention Type OTHER

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

Healthy Individuals

Healthy Individuals

Group Type EXPERIMENTAL

Peripheral nerve stimulation

Intervention Type OTHER

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

Commercial knee brace

Intervention Type DEVICE

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

Interventions

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Peripheral nerve stimulation

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

Intervention Type OTHER

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

MetroHealth Medical Center

OTHER

Sponsor Role lead

Responsible Party

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James Sulzer

Associate Professor, Department of Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James S Sulzer

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

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MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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R01HD100416

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017-01-0022

Identifier Type: -

Identifier Source: org_study_id