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NCT04043234 · ClinicalTrials.gov registry record
RESCU System for Robust Upper Limb Prosthesis Control
A clinical trial of Amputation and Upper Limb, sponsored by Infinite Biomedical Technologies.
- Completed
- Registry status
- 4
- Enrollment target
- 1
- Study location
NCT04043234: Completed study of Amputation and Upper Limb, sponsored by Infinite Biomedical Technologies.
NCT04043234 is a study of Amputation and Upper Limb that has completed, run by Infinite Biomedical Technologies. The registered enrollment target is 4 participants, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04043234, a study of Amputation and Upper Limb, has completed, sponsored by Infinite Biomedical Technologies.
- COMPLETED
- Registry status
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will compare the use of RESCU \[Experimental\] Prosthesis with a \[Standard\] pattern recognition prosthesis in a clinical setting and in unsupervised daily activity. The protocol will follow a single case experimental design (SCED) to compensate for the limited size of the patient population. Each of the participants will use the Standard and Experimental and systems over a 35-day period. The Standard system will include at least two controllable DoFs (hand, wrist, multi-articulated hand, etc) and a commercially-available pattern recognition controller. The RESCU system will use the same components as the Standard system but will differ with respect to incorporating eight IBT Element Electrodes (as required for pattern recognition control) and the RESCU control software. The hypothesis is that pattern recognition will outperform the commercially-available control strategy for most participants on in-clinic, at-home usage, and subjective measures.
Primary Outcome
Prosthesis usage time was monitored as a proxy for user satisfaction, under the assumption that when an individual is more satisfied with their prosthetic solution, they will use it more in their daily lives. For the experimental intervention, the mean daily prosthesis use duration is reported as the average number of hours the prosthesis was used daily over the evaluation period (i.e., four weeks). For the control intervention, the mean daily prosthesis use duration is reported as the average n
Conditions Studied
Interventions
- DEVICE RESCU
- DEVICE Pattern Recognition
Study Locations (1)
Maryland
- Medical Center O&P - Silver Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2023-11-07 |
| Est. Completion | 2023-12-19 |
What the finished NCT04043234 record still lists
NCT04043234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Amputation appearing as the primary indexed condition, and to 2 interventions - of which RESCU is the first listed.
NCT04043234 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04043234 about?
NCT04043234 is a clinical study titled "RESCU System for Robust Upper Limb Prosthesis Control". This study will compare the use of RESCU \[Experimental\] Prosthesis with a \[Standard\] pattern recognition prosthesis in a clinical setting and in unsupervised daily activity. The protocol will follow a single case experimental design (SCED) to compensate for the limited size of the patient popula...
What is the current status of trial NCT04043234?
This trial is currently completed. The enrollment target is 4 participants. The study started on 2023-11-07. Estimated completion is 2023-12-19.
What conditions does trial NCT04043234 study?
This clinical trial studies the following conditions: Amputation, Upper Limb.
What interventions are being tested in trial NCT04043234?
The interventions under investigation include: RESCU (DEVICE), Pattern Recognition (DEVICE).
Who is sponsoring clinical trial NCT04043234?
This trial is sponsored by Infinite Biomedical Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04043234 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04043234's enrollment target sits among peer trials
4 63rd of 65 higher than 3 of 65 other Amputation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amputation 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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