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Powered Motorized Orthoses

Neuromechanical Gait Assist for Stroke Recovery

N/A

Waitlist Available

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

Must not have

Severe knee extensor tone requiring >25Nm of torque to flex the knee

Ankle contractures of more than 0 degrees of plantar flexion and hip contractures of greater than 0 degrees of hip flexion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one year after baseline

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My knee is very stiff, needing a lot of force to bend.

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I have stiffness in my ankles and hips that limits their movement.

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I cannot grasp with either of my hands.

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I have swelling in one of my limbs.

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I do not have sepsis or any active infections.

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I have active sores or wounds on my legs.

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I experience seizures that my medication cannot control.

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I have severe difficulties in thinking and communicating.

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I have severe osteoporosis.

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I have a history of serious heart rhythm problems.

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I have Parkinson's Disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one year after baseline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Controller accuracy

Secondary study objectives

10m walk test

6 minute timed walk

Fugl-Meyer Motor Assessment

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 18Eligibility criteria met