Status:
ACTIVE_NOT_RECRUITING
Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke
Lead Sponsor:
VA Office of Research and Development
Conditions:
Stroke
Hemiparesis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Objective: The goal of this study is to implement and test a neuro-mechanical gait assist (NMGA) device to correct walking characterized by muscle weakness, incoordination or excessive tone in Veteran...
Detailed Description
This study includes controller development and feasibility testing for a hybrid neuromuscular gait assist (NMGA) system to enhance walking after stroke. The study consists of baseline testing, fitting...
Eligibility Criteria
Inclusion
- More than 6 months post stroke.
- Stiff-legged gait defined as a gait pattern manifesting as "dragging" or "catching" of the affected toes during swing phase of gait or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip.
- Sufficient endurance and motor ability to ambulate at least 10ft continuously with standby assist.
- Weakness at the hip, knee and ankle.
- Poor lower extremity coordination due to weakness or tone.
- Hip extension range to neutral.
- Hip flexion range greater or equal to 90 degrees.
- Passive range of ankle dorsiflexion to neutral with knee extended.
- Sufficient upper extremity function to use a cane.
Exclusion
- 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.
- Inability to grasp with both hands.
- History of potentially fatal cardiac arrhythmias such as ventricular tachycardia, supra-ventricular tachycardia, and rapid ventricular response atrial fibrillation with hemodynamic instability.
- Presence of a demand pacemaker.
- Parkinson's Disease.
- Edema of the affected limb.
- Active pressure ulcers or wounds in lower extremities.
- Sepsis or active infection.
- Severe osteoporosis.
- Uncontrolled seizures.
- Presence of substance abuse.
- Severely impaired cognition and communication.
- Uncompensated hemineglect.
- Pregnancy.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2026
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04116671
Start Date
April 1 2020
End Date
November 1 2026
Last Update
November 13 2025
Active Locations (1)
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1
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106-1702