Enhancing Upper Limb Prostheses With Radio Frequency Identification (RFIDIBT)

March 4, 2014 updated by: Infinite Biomedical Technologies

Validation of a Control Method for Upper Limb Myoelectric Prostheses Using Radio Frequency Identification (RFID)

The purpose of this study is to determine if Radio Frequency Identification (RFID) can lead to greater prosthesis function and control. Subjects are asked to perform specific tasks and actions using the traditional control method, as well as RFID control.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21218-3637
        • Johns Hopkins Eastern Campus
      • Baltimore, Maryland, United States, 21218
        • Johns Hopkins Eastern Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 or greater.
  2. Below elbow amputation, unilateral or bilateral.
  3. Chronic stable amputation: > 6 months from amputation.
  4. Stable prosthesis prescription: > 3 months since last major prosthesis modification.
  5. Cognitively intact, as determined by Mini-Mental Status Examination score > 24.
  6. Able to provide informed consent and available to participate in study activities.
  7. No severe residual limb motor/sensory impairment or pain likely to interfere with treatment.
  8. Expected to be medically and psychiatrically stable for study duration.

Exclusion Criteria:

  1. Patients with diseases which weaken and/or adversely affect the control of skeletal muscle.
  2. Patients with poor skin integrity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Functional Assessment
Participant will be asked to perform a series of tasks involving their prosthesis. These tasks can involve switching grips as well as moving objects.
Device: Morph
Morph is a small electric controller that is retrofit into existing myoelectric prostheses to equip them with wireless identification capabilities. Specifically, Morph allows the prosthesis to react to RFID tags in the environment.
Other Names:
  • Myoelectrically-Operated RFID Prosthetic Hand

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required to perform different functional tasks
Time Frame: 12 weeks
Each participant will perform functional tests on the first visit. These tests consist of moving objects from one location to another, and performing certain muscle contraction patterns when prompted. The participant will then take the prosthesis, installed with morph, home for 3 months at most, and then return to perform another set of timed trials.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaires on prosthesis function and satisfaction
Time Frame: 20 minutes per questionnaire, total of 3 different questionnaires administered twice each
The questionnaires offer the participant the opportunity to express their experience and satisfaction with their prosthesis, during different tasks and at home.
20 minutes per questionnaire, total of 3 different questionnaires administered twice each

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infinite Biomedical Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

September 26, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimate)

October 22, 2013

Study Record Updates

Last Update Posted (Estimate)

March 5, 2014

Last Update Submitted That Met QC Criteria

March 4, 2014

Last Verified

October 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • RFID-IBT-3600

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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