Enhancing Upper Limb Prostheses With Radio Frequency Identification
RFIDIBT
Validation of a Control Method for Upper Limb Myoelectric Prostheses Using Radio Frequency Identification (RFID)
1 other identifier
interventional
10
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2013
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 26, 2013
CompletedFirst Posted
Study publicly available on registry
October 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 5, 2014
October 1, 2013
8 months
September 26, 2013
March 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Time required to perform different functional tasks
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 Outcomes (1)
Questionnaires on prosthesis function and satisfaction
20 minutes per questionnaire, total of 3 different questionnaires administered twice each
Study Arms (1)
Functional Assessment
EXPERIMENTALParticipant will be asked to perform a series of tasks involving their prosthesis. These tasks can involve switching grips as well as moving objects.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age 18 or greater.
- Below elbow amputation, unilateral or bilateral.
- Chronic stable amputation: \> 6 months from amputation.
- Stable prosthesis prescription: \> 3 months since last major prosthesis modification.
- Cognitively intact, as determined by Mini-Mental Status Examination score \> 24.
- Able to provide informed consent and available to participate in study activities.
- No severe residual limb motor/sensory impairment or pain likely to interfere with treatment.
- Expected to be medically and psychiatrically stable for study duration.
You may not qualify if:
- Patients with diseases which weaken and/or adversely affect the control of skeletal muscle.
- Patients with poor skin integrity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Johns Hopkins Eastern Campus
Baltimore, Maryland, 21218-3637, United States
Johns Hopkins Eastern Campus
Baltimore, Maryland, 21218, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2013
First Posted
October 22, 2013
Study Start
August 1, 2013
Primary Completion
April 1, 2014
Study Completion
June 1, 2014
Last Updated
March 5, 2014
Record last verified: 2013-10