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NCT04272593 · ClinicalTrials.gov registry record · NA
Pattern Recognition Prosthetic Control
A NA study of Prosthesis User and Amputation; Traumatic, Limb, sponsored by Coapt.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT04272593: Completed NA study of Prosthesis User and Amputation; Traumatic, Limb, sponsored by Coapt.
NCT04272593 is a NA study of Prosthesis User and Amputation; Traumatic, Limb that has completed, run by Coapt. The registered enrollment target is 8 participants, below the 57-participant average among 12 other Prosthesis User trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04272593, a NA study of Prosthesis User and Amputation; Traumatic, Limb, has completed, sponsored by Coapt.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
This study investigates whether simultaneous electromyographic (EMG)-based pattern recognition control of an upper limb prostheses increases wear time among users. In contrast to conventional, seamless sequential pattern recognition style of control which only allows a single prosthetic hand or arm function at a time, simultaneous control allows for more than one at the same time. Participants will wear their prosthesis as they would normally at home using each control style for an 8-week period with an intermittent 1-week washout period (17 weeks total). Prosthetic usage will be monitored; including, how often participants wear their device and how many times they move each degree of freedom independently or simultaneously. The primary hypothesis is that prosthetic users will prefer simultaneous control over conventional control which will result in wearing their device more often. The secondary hypothesis is that simultaneous control will result in more efficient prosthesis control which will make it easier for participants to perform activities of daily living. The results of this study will help identify important factors related to prosthetic users' preferences while freely wearing their device within their own daily-life environment.
Primary Outcome
We will record each instance participants turn on or off their pattern recognition device throughout the home trial. Prosthetic wear time is defined as the cumulative amount of time participants keep their pattern recognition device turned on during the course of each 8-week period. We will perform a statistical analysis to compare wear time when using each type of pattern recognition control (simultaneous and seamless, sequential). We will complete a repeated measures analysis of variance with
Conditions Studied
Interventions
- DEVICE EMG-Pattern Recognition Controller
Study Locations (1)
Illinois
- Coapt, LLC - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-11-16 |
| Est. Completion | 2022-07-18 |
| Phase | NA |
What the finished NCT04272593 record still lists
NCT04272593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 57-participant average among 12 other Prosthesis User trials with a reported enrollment target (86% lower).
The record links to 3 conditions, with Prosthesis User appearing as the primary indexed condition, and to 1 intervention - of which EMG-Pattern Recognition Controller is the first listed.
NCT04272593 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04272593 about?
NCT04272593 is a clinical study titled "Pattern Recognition Prosthetic Control". This study investigates whether simultaneous electromyographic (EMG)-based pattern recognition control of an upper limb prostheses increases wear time among users. In contrast to conventional, seamless sequential pattern recognition style of control which only allows a single prosthetic hand or arm ...
What is the current status of trial NCT04272593?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2020-11-16. Estimated completion is 2022-07-18.
What conditions does trial NCT04272593 study?
This clinical trial studies the following conditions: Prosthesis User, Amputation; Traumatic, Limb, Congenital Amputation of Upper Limb.
What interventions are being tested in trial NCT04272593?
The interventions under investigation include: EMG-Pattern Recognition Controller (DEVICE).
Who is sponsoring clinical trial NCT04272593?
This trial is sponsored by Coapt, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04272593 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04272593's enrollment target sits among peer trials
8 11th of 12 higher than 2 of 12 other Prosthesis User trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prosthesis User 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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