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Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke
NCT04116671 · View on ClinicalTrials.gov ↗
Study 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 Veterans with hemiparesis after stroke that adversely affects their ability to walk, exercise, perform activities of daily living, and participate fully in personal, professional and social roles. Research Plan: A prototype NMGA device will be used to develop a finite state controller (FSC) to coordinate each user's volitional effort with surface muscle stimulation and motorized knee assistance as needed. Brace mounted sensors will be used to develop a gait event detector (GED) which will serve the FSC to advance through the phases of gait or stair climbing. In addition, a rule-base intent detection algorithm will be developed using brace mounted sensors and user interface input to select among various functions including walking, stairs climbing, sit-to-stand and stand-to-sit maneuvers. The FSC controller tuning and intent algorithm development and evaluation will be on pilot subjects with difficulty walking after stroke. Outcome measures during development will provide specifications for a new prototype NMGA design which will be evaluated on pilot subjects to test the hypothesis that the NMGA improves walking speed, distance and energy consumption of walking. These baseline data and device will be used to design a follow-up clinical trial to measure orthotic impact of NMGA on mobility in activities of daily living at home and community. Methodology: After meeting inclusion criteria, pilot subjects will undergo baseline gait evaluation with EMG activities of knee flexors and extensors, ankle plantar and dorsiflexors and isokinetic knee strength and passive resistance. They will be fitted with a NMGA combining a knee-ankle-foot-orthosis with a motorized knee joint and surface neuromuscular stimulation of plantar- and dorsi- flexors, vasti and rectus femoris. Brace mounted se
Conditions Studied
Interventions
- DEVICE Neuromechanical Gait Assist
Study Locations (1)
Ohio
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-04-01 |
| Est. Completion | 2026-11-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04116671
The ClinicalTrials.gov registry entry for NCT04116671 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Stroke appearing as the primary indexed condition, and to 1 intervention — of which Neuromechanical Gait Assist is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04116671 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04116671 about?
NCT04116671 is a clinical study titled "Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke". 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 Veterans with hemiparesis after stroke that adversely affects their ability to walk, exercise, perform acti...
What is the current status of trial NCT04116671?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 5 participants. The study started on 2020-04-01. Estimated completion is 2026-11-01.
What conditions does trial NCT04116671 study?
This clinical trial studies the following conditions: Stroke, Hemiparesis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04116671?
The interventions under investigation include: Neuromechanical Gait Assist (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04116671?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04116671 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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