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Reflex Excitability in Post-stroke Stiff-Knee Gait

Primary Purpose

Stroke, Chronic Stroke, Gait, Hemiplegic

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Peripheral nerve stimulation

Commercial knee brace

About this trial

This is an interventional basic science trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

MetroHealth Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Post-stroke Stiff-Knee Gait Participants

Healthy Individuals

Arm Description

Individuals with post-stroke Stiff-Knee gait

Healthy Individuals

Outcomes

Primary Outcome Measures

Surface electromyographic recording of leg muscles during different conditions

Recording electrical activity of leg muscles during walking in response to peripheral nerve stimulation

Secondary Outcome Measures

Circumduction measure

Hip abduction joint motion measured with motion capture

Full Information

NCT ID

NCT04947865

First Posted

June 11, 2021

Last Updated

March 15, 2023

Sponsor

MetroHealth Medical Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04947865

Brief Title

Reflex Excitability in Post-stroke Stiff-Knee Gait

Official Title

Characterization of Abnormal Reflex Couplings Via H-reflex Stimulation

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 11, 2021 (Actual)

Primary Completion Date

June 11, 2025 (Anticipated)

Study Completion Date

June 11, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

MetroHealth Medical Center

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Post-stroke Stiff-Knee Gait Participants

Arm Type

Experimental

Arm Description

Individuals with post-stroke Stiff-Knee gait

Arm Title

Healthy Individuals

Arm Type

Experimental

Arm Description

Healthy Individuals

Intervention Type

Other

Intervention Name(s)

Peripheral nerve stimulation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Commercial knee brace

Intervention Description

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

Primary Outcome Measure Information:

Title

Surface electromyographic recording of leg muscles during different conditions

Description

Recording electrical activity of leg muscles during walking in response to peripheral nerve stimulation

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

Circumduction measure

Description

Hip abduction joint motion measured with motion capture

Time Frame

1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

James Sulzer, PhD

Phone

5125419036

jss280@case.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kristine Hansen, PT

khansen1@metrohealth.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James S Sulzer

Organizational Affiliation

Case Western Reserve University

Official's Role

Principal Investigator

Facility Information:

Facility Name

MetroHealth Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

James S Sulzer, PhD

Phone

512-541-9036

jss280@case.edu

12. IPD Sharing Statement

Learn more about this trial

Reflex Excitability in Post-stroke Stiff-Knee Gait

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