CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4 enrolled
Drug / intervention
RESCU +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04043234
NCT04043234N/ACompleted

User-driven Retrospectively Supervised Classification Updating (RESCU) System for Robust Upper Limb Prosthesis Control

Infinite Biomedical Technologies·interventional·Posted Aug 2, 2019·Updated Apr 24, 2024

In Brief

A clinical study evaluating RESCU and Pattern Recognition for Amputation and Upper Limb. Completed, enrolled 4 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 2, 2019
Enrollment StartNov 7, 2023
Primary CompletionDec 19, 2023
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 6.9 years ago

Interventions

RESCUdevice

Retrospectively Supervised Classification Updating (RESCU) is founded on two innovations that promise significant improvement in performance and outcome. The first is a highly robust machine intelligence algorithm, an Extreme Learning Machine with Adaptive Sparse Representation (EASRC), and the second is a novel adaptive learning algorithm and communication interface we call Nessa. We contend that these two technologies allow the prosthetic device to adapt to its user from the initial fitting through continuing, long-term use in the activities of daily living, shifting the paradigm of training from the current prospective data gathering methods to a more dynamic retrospective application.

Pattern Recognitiondevice

Pattern recognition prostheses associate the patterns of activity of multiple EMG sites to the action of a prosthesis. Such strategies have historically required prospective calibration of the EMG activation patterns.