Wireless Prosthetic Control Effectiveness Study

NCT06821412 | Completed Results

• 2 other identifiers: IRB-23-0722W81XWH22C0049
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this proposed project is to evaluate the effectiveness of our novel wireless electrode system, which the investigators refer to as the Asterisk system, on transradial prosthesis users. There are numerous benefits to the upper limb prosthesis community being able to utilize wireless electrodes. These benefits include allowing for the use of a prosthetics liner to assist with fit and comfort, easier implementation of electromyography (EMG) controlled (also referred to as myoelectric control) prosthesis for individuals with osseointegration, and additional EMG electrode location options if the muscle activity captured within the prosthetic socket does not provide reliable prosthesis control. The investigators intend to use this data to develop the Asterisk wireless electrode system into a commercial product. The findings will also be shared with the research community to help drive the design of future devices.

Conditions

Prostheses; Upper Limb Amputation Below Elbow

Outcome Measures

Primary Outcomes (1)

• Orthotics and Prosthetics User Survey - Satisfaction With Device (OPUS-SD)

  The Orthotics and Prosthetics User's Survey (OPUS) is a self-report questionnaire consisting of five modules. The version of the OPUS which will be administered consists of 9 questions in 1 category (satisfaction with device). Questions are asked and scored on a scale from 0-4 (0=strongly disagree, 1=disagree, 2=neither agree nor disagree, 3=agree, and 4=strongly agree), with a higher value indicating a better outcome. There is an additional response for "Don't know / Not Applicable", which if chosen, is not included in the scoring. This survey will be given at the end of each study condition (2 conditions, 1 month per condition). Analysis is reported as a value that calculates the average of all questions (sum up all questions and divide by total number of questions).

  At the end of each 1 month condition

Study Arms (2)

Wireless Control

EXPERIMENTAL

The participant wears the experimental socket in the wireless configuration using the prototype ASTERISK system connected within the electronics of the prosthetic socket. The electronics are not accessible by the participant which allows both configurations to be blinded to the participants.

Device: ASTERISK System

Wired Control

SHAM COMPARATOR

The participant wears the experimental socket in the wired configuration, which mimics the current setup for EMG-controlled prostheses. The electronics are not accessible by the participant which allows both configurations to be blinded to the participants.

Device: Wired Configuration

Interventions

ASTERISK System DEVICE

This intervention uses an experimental socket fabricated by a certified prosthetist. The electronics within the experimental socket are set up with the ASTERISK system, which sends information collected from the EMG sensors to the prosthetic hand wirelessly rather than the current available method of wired control.

Wireless Control

Wired Configuration DEVICE

This intervention uses the same experimental socket that is used for the ASTERISK intervention. The prosthesis is set-up with wired EMG control, which is the current available method for EMG-controlled prostheses.

Wired Control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• current wearers of trans-radial myoelectric prostheses or orthoses
• have used their prostheses/orthoses for at least six months
• understand spoken and written English (for the purpose of consenting)

You may not qualify if:

• have any neurological or physical conditions which would prevent them from performing the experimental tasks
• are pregnant

Sponsors & Collaborators

• Liberating Technologies, Inc.: lead
• University of Hartford: collaborator
• Worcestor Polytechnic Institute (WPI): collaborator

Study Sites (1)

Liberating Technologies, Inc.

Holliston, Massachusetts, 01746, United States

Location

Results Point of Contact

• Title: Jen Johansson
• Organization: Liberating Technologies, Inc.

jen.johansson@liberatingtech.com

774-233-0874

Study Officials

• Benjamin McDonald

  Liberating Technologies, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 12, 2025
• Study Start: June 13, 2024
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: November 4, 2025
• Results First Posted: November 4, 2025

Record last verified: 2025-10

Locations

US (1)