RESCU System for Robust Upper Limb Prosthesis Control

Status Completed

Clinical Trial 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.

Clinical Trial Description

The AB sequence for the study protocol is described below, where control type A is the Standard prosthesis and control type B is the Experimental prosthesis. On Day 0, the participant will be evaluated with the Standard prosthesis. A series of Measures (as defined in the next paragraph) will then be recorded. The participant will then take the prosthesis home for one week, and daily use data will be recorded. The participant will return to the clinic for Day 7 Measures and download of the daily use data. During this session, the participant will be fit with the second system, undergo occupational therapy in the clinic, and Measures will be recorded. There will be no washout period as the prosthesis is expected to be in daily use. The participants will go home for a four-week period and return on Day 35 for a third set of Measures. At this time, the participant will be asked which prosthesis he/she prefers. There are limited functional outcome assessment options for the planned comparison. However, the investigators will test functional measures at the clinic appointments, examine daily use data, and administer several qualitative surveys to assess participant outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04043234
Study type	Interventional
Source	Infinite Biomedical Technologies
Contact
Status	Completed
Phase
Start date	November 7, 2023
Completion date	December 19, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

RESCU System for Robust Upper Limb Prosthesis Control — RESCU

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms