N/A
N=4
RESCU System for Robust Upper Limb Prosthesis Control
Amputation · Upper Limb
Bottom Line
View on ClinicalTrials.gov: NCT04043234 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Mean Daily Prosthesis Use Duration — 3.81; 6.83 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RESCU (Device); Pattern Recognition (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Infinite Biomedical Technologies
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Daily Prosthesis Use Duration |
3.81; 6.83 | — |
| SECONDARY Activities Measure for Upper Limb Amputees (AM-ULA) |
— | — |
| SECONDARY Orthotics and Prosthetics User's Survey Upper Extremity Functional Status (OPUS UEFS) |
— | — |
| SECONDARY Trinity Amputation and Prosthesis Experience Survey for Upper Limb Amputation (TAPES-ULA) |
— | — |
| SECONDARY PROMIS Satisfaction Short Form 8a |
— | — |
| SECONDARY Pain Scale |
— | — |
| SECONDARY Socket Comfort Score |
— | — |
| SECONDARY Range of Motion (of Residual Joints) |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Trans-radial limb difference.
- Candidate for a 2+ degree-of-freedom (DoF) myoelectric pattern recognition prosthesis as determined by the study prosthetist
- Active pattern recognition myoelectric prosthesis user
- Fluent in English
- Age of 18 years or greater
Exclusion Criteria
- Patients with a residual limb that is unhealed from the amputation surgery
- Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes
- Unhealed wounds
- Significant cognitive deficits as determined upon clinical evaluation
- Significant neurological deficits as determined upon clinical evaluation
- Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
- Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
- Serious uncontrolled medical problems as judged by the project therapist
Data sourced from ClinicalTrials.gov (NCT04043234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.