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NCT04116671 · ClinicalTrials.gov registry record · NA
Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke
A NA study of Stroke and Hemiparesis, sponsored by VA Office of Research and Development.
- Active
- Registry status
- NA
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT04116671: Active NA study of Stroke and Hemiparesis, sponsored by VA Office of Research and Development.
NCT04116671 is a NA study of Stroke and Hemiparesis that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 5 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04116671, a NA study of Stroke and Hemiparesis, is active but no longer recruiting, sponsored by VA Office of Research and Development.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
The accuracy of the controller (True/False positives and negatives) in detecting gait events and gait transitions.
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 |
What the registry record for NCT04116671 still lists
NCT04116671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower).
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.
NCT04116671 reports a single indexed study location in Ohio.
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.
What interventions are being tested in trial NCT04116671?
The interventions under investigation include: Neuromechanical Gait Assist (DEVICE).
Who is sponsoring clinical trial NCT04116671?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04116671's enrollment target sits among peer trials
5 439th of 454 higher than 11 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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