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CompletedNCT04947865Updated Sep 4, 2026

Reflex Excitability in Post-stroke Stiff-Knee Gait

An interventional study of Peripheral nerve stimulation and Commercial knee brace in Stroke, Chronic Stroke and Gait, Hemiplegic, sponsored by MetroHealth Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by MetroHealth Medical Center · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Jun 2025, 1 year 3 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Stroke
  • Chronic Stroke
  • Gait, Hemiplegic
  • Gait, Spastic
  • Gait Disorder, Sensorimotor
  • Gait Disorders, Neurologic
  • Walking, Difficulty
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 54 is close to the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

MetroHealth Medical Center is the lead sponsor of 101 studies on the registry; 19 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Post-stroke Stiff-Knee Gait Participants

    Individuals with post-stroke Stiff-Knee gait

    Other: Peripheral nerve stimulation

  • Experimental
    Healthy Individuals

    Healthy Individuals

    Other: Peripheral nerve stimulation · Device: Commercial knee brace

Interventions

  • OtherPeripheral nerve stimulation

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

  • DeviceCommercial 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.

06

What researchers measure

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

    Time frame: 1 hour

Secondary outcomes

  1. Circumduction measure

    Hip abduction joint motion measured with motion capture

    Time frame: 1 hour

07

Study locations

1 site
  • MetroHealth Medical Center
    Cleveland, Ohio 44109, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04947865
Lead sponsor
MetroHealth Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
James Sulzer (Associate Professor, Department of Physical Medicine and Rehabilitation, MetroHealth Medical Center) — Principal investigator
First posted
Jul 1, 2021
Start date
Jun 11, 2021
Primary completion
Jun 11, 2025
Completion
Jul 29, 2026
Last update
Sep 4, 2026

Study contacts

James S Sulzer
principal investigator · Case Western Reserve University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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