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NCT07032753 · ClinicalTrials.gov registry record · NA
Neuromusculoskeletal Interface for Bionic Arms
A NA study, sponsored by Shirley Ryan AbilityLab.
- Not yet
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT07032753 is a NA study that has not yet begun recruiting, run by Shirley Ryan AbilityLab. The registered enrollment target is 12 participants.
The verdict
NCT07032753, a NA study, has not yet begun recruiting, sponsored by Shirley Ryan AbilityLab.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
The overall objective of this proposal is to perform a first-in-human home trial of the Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations who have had Targeted Muscle Reinnervation (TMR) surgery and use a pattern recognition-controlled myoelectric prosthesis. The purpose of the study is to capture preliminary safety and effectiveness information on the e-OPRA device when used with the prosthetic systems. The investigators expect that the e-OPRA implant system will be safe and provide clinically and statistically significant improvements in control and comfort. Specifically, the investigators hypothesize that the e-OPRA system will (1) allow for training of more functional prosthesis controllers, (2) provide more stable electromyographic (EMG) signals, reducing the need to recalibrate the prosthetic control system, and (3) be more comfortable, as it does not require a tethered arm-band to record surface EMG signals. Phase 1: Perform TMR and e-OPRA surgeries in 8 persons with transhumeral amputations. Phase 2: Perform a randomized cross-over study to compare the OPRA and e-OPRA system (without sensory feedback) in 8 transhumeral amputees who have received TMR. Phase 3: Perform a randomized cross-over study to compare the e-OPRA system with and without sensory feedback in 8 transhumeral amputees who have received TMR.
Interventions
- DEVICE OPRA
- DEVICE eOPRA
- DEVICE eOPRA with sensory feedback
- DEVICE eOPRA without sensory feedback
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-01-01 |
| Est. Completion | 2029-05-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07032753
The ClinicalTrials.gov registry entry for NCT07032753 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shirley Ryan AbilityLab, which has 138 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which OPRA is the first listed.
NCT07032753 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07032753 about?
NCT07032753 is a clinical study titled "Neuromusculoskeletal Interface for Bionic Arms". The overall objective of this proposal is to perform a first-in-human home trial of the Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations who have had Targeted Muscle Reinnervation (TMR) surgery and use a patte...
What is the current status of trial NCT07032753?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2026-01-01. Estimated completion is 2029-05-31.
What interventions are being tested in trial NCT07032753?
The interventions under investigation include: OPRA (DEVICE), eOPRA (DEVICE), eOPRA with sensory feedback (DEVICE), eOPRA without sensory feedback (DEVICE).
Who is sponsoring clinical trial NCT07032753?
This trial is sponsored by Shirley Ryan AbilityLab, which has 138 total clinical trials registered on ClinicalTrials.gov.
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