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Enhancing Upper Limb Prostheses With Radio Frequency Identification (RFIDIBT)

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ClinicalTrials.gov Identifier: NCT01967004
Recruitment Status : Unknown
Verified October 2013 by Infinite Biomedical Technologies.
Recruitment status was:  Active, not recruiting
First Posted : October 22, 2013
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):
Infinite Biomedical Technologies

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
Below Elbow Amputation Device: Morph Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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 : August 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

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 Name: Myoelectrically-Operated RFID Prosthetic Hand




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967004


Locations
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United States, Maryland
Johns Hopkins Eastern Campus
Baltimore, Maryland, United States, 21218-3637
Johns Hopkins Eastern Campus
Baltimore, Maryland, United States, 21218
Sponsors and Collaborators
Infinite Biomedical Technologies

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Responsible Party: Infinite Biomedical Technologies
ClinicalTrials.gov Identifier: NCT01967004     History of Changes
Other Study ID Numbers: RFID-IBT-3600
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: October 2013