Overview

This trial is active, not recruiting.

Condition below elbow amputation
Treatment morph
Sponsor Infinite Biomedical Technologies
Start date August 2013
End date April 2014
Trial size 10 participants
Trial identifier NCT01967004, RFID-IBT-3600

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Participant will be asked to perform a series of tasks involving their prosthesis. These tasks can involve switching grips as well as moving objects.
morph Myoelectrically-Operated RFID Prosthetic Hand
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.

Primary Outcomes

Measure
Time required to perform different functional tasks
time frame: 12 weeks

Secondary Outcomes

Measure
Questionnaires on prosthesis function and satisfaction
time frame: 20 minutes per questionnaire, total of 3 different questionnaires administered twice each

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Validation of a Control Method for Upper Limb Myoelectric Prostheses Using Radio Frequency Identification (RFID)
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Infinite Biomedical Technologies.