Clincosm LogoSign in Get a demo

RFIDIBT: Enhancing Upper Limb Prostheses With Radio Frequency Identification

Sponsor
Infinite Biomedical Technologies (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01967004
Collaborator
(none)
10
Enrollment
2
Locations
1
Arm
10
Duration (Months)
5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Morph
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Validation of a Control Method for Upper Limb Myoelectric Prostheses Using Radio Frequency Identification (RFID)
Study Start Date :
Aug 1, 2013
Anticipated Primary Completion Date :
Apr 1, 2014
Anticipated Study Completion Date :
Jun 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time required to perform different functional tasks [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.

    Secondary Outcome Measures

    1. Questionnaires on prosthesis function and satisfaction [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Eastern Campus Baltimore Maryland United States 21218-3637
    2 Johns Hopkins Eastern Campus Baltimore Maryland United States 21218

    Sponsors and Collaborators

    • Infinite Biomedical Technologies

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Infinite Biomedical Technologies
    ClinicalTrials.gov Identifier:
    NCT01967004
    Other Study ID Numbers:
    • RFID-IBT-3600
    First Posted:
    Oct 22, 2013
    Last Update Posted:
    Mar 5, 2014
    Last Verified:
    Oct 1, 2013

    Study Results

    No Results Posted as of Mar 5, 2014