RESCU System for Robust Upper Limb Prosthesis Control

Completed

Conditions studied: Amputation, Upper Limb

In brief

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.

Key facts

Study ID

NCT04043234

Run by

Infinite Biomedical Technologies

People needed

4

Starts

2023-11-07

Expected to finish

2023-12-19

Last updated by the study team

2024-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical Center O&P — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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