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Powered Motorized Orthoses

Neuromechanical Gait Assist for Stroke Recovery

N/A

Recruiting

Led By Ronald Triolo, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Passive range of ankle dorsiflexion to neutral with knee extended

Hip flexion range greater or equal to 90 degrees

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one year after baseline

Awards & highlights

Study Summary

This trial is testing a neuro-mechanical gait assist (NMGA) device to improve walking for Veterans with hemiparesis after stroke. The NMGA device is a knee-ankle-foot-orthosis with a motorized knee joint and surface neuromuscular stimulation of plantar- and dorsi- flexors, vasti and rectus femoris. The device is controlled by a finite state controller (FSC) which coordinates feed-forward control of tuned stimulation patterns and closed-loop controlled knee power assist as needed to control foot clearance during swing and stability of the knee during stance.

Who is the study for?

This trial is for Veterans with hemiparesis after a stroke, who can walk at least 10ft with some help and have enough upper body function to use a cane. They should be over 6 months post-stroke and have specific ranges of motion in their hips and ankles. People with severe muscle tone issues, joint contractures, infections, pregnancy, certain heart conditions or severe cognitive impairments cannot participate.Check my eligibility

What is being tested?

The study tests a new device called NMGA that helps correct walking problems caused by strokes. It combines leg braces with motorized knee joints and electrical muscle stimulation. The goal is to improve walking speed, distance covered, energy used when walking, safety and stability.See study design

What are the potential side effects?

Potential side effects may include skin irritation from the brace or electrodes, muscle fatigue due to stimulation or discomfort from the orthosis adjustment. However, specifics will depend on individual reactions to the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can move my ankle up to a neutral position without help when my leg is straight.

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I can lift my knee toward my chest at least halfway.

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I can use a cane with my arms.

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I can walk at least 10 feet on my own with someone nearby for safety.

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I have trouble moving my legs properly because they are weak or stiff.

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I have difficulty walking smoothly and tend to drag or lift my leg in an unusual way.

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I experience weakness in my hip, knee, and ankle.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Controller accuracy

Secondary outcome measures

10m walk test

6 minute timed walk

Fugl-Meyer Motor Assessment

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neuromechanical Gait AssistExperimental Treatment1 Intervention

All participants will participate in developing controllers to coordinate device assistance with walking ability. Walking will be compared before gait training and after gait training. Walking will be evaluated both with and without device assistance.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,618 Previous Clinical Trials

3,316,163 Total Patients Enrolled

84 Trials studying Stroke

6,738 Patients Enrolled for Stroke

Ronald Triolo, PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH

4 Previous Clinical Trials

46 Total Patients Enrolled

Media Library

Neuromechanical Gait Assist (Powered Motorized Orthoses) Clinical Trial Eligibility Overview. Trial Name: NCT04116671 — N/A

Stroke Research Study Groups: Neuromechanical Gait Assist

Stroke Clinical Trial 2023: Neuromechanical Gait Assist Highlights & Side Effects. Trial Name: NCT04116671 — N/A

Neuromechanical Gait Assist (Powered Motorized Orthoses) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04116671 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being inducted into this experiment?

"Affirmative. According to information on clinicaltrials.gov, this research is currently enrolling participants; it was initially posted on April 1st 2020 and updated most recently on January 26th 2022. The study seeks ten patients from a single medical centre."

Answered by AI

Does the eligibility for this clinical trial preclude adults aged 25 or older?

"The requirements for entry into this medical trial are limited to those aged 18-75. Separately, there exist 43 studies targeting younger patients and 1,028 opportunities available for seniors."

Answered by AI

What qualifications must potential participants meet to be eligible for this clinical trial?

"This clinical trial seeks to enroll 10 individuals aged between 18-75 with a history of stroke. To be eligible, applicants must demonstrate sufficient physical stamina and motor ability while ambulating at least ten feet without assistance, have experienced the effects of their stroke for more than six months, display signs of stiff-legged gait such as 'dragging' or 'catching', weakness in hip, knee and ankle areas, hip extension range to zero degrees ,hip flexion range greater than 90 degrees, adequate passive dorsiflexion when the knee is extended as well as enough upper extremity strength to handle a cane."

Answered by AI

Are researchers presently enrolling participants for this experiment?

"Based on the information provided by clinicaltrials.gov, this trial is actively recruiting patients; it was initially posted in April of 2020 and has most recently been updated as of January 26th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke

2020. "Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04116671.

All > Stroke