Enhancing Upper Limb Prostheses With Radio Frequency Identification

Not Applicable

• Conditions: Below Elbow Amputation
• Interventions: Device: Morph

• Registration Number: NCT01967004
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-26
• Status Verified: 2013-10
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-22
• Last Update Submitted: 2014-03-04
• Last Update Posted: 2014-03-05
• Primary Completion: 2014-04
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Functional Assessment	Morph	Participant will be asked to perform a series of tasks involving their prosthesis. These tasks can involve switching grips as well as moving objects.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Johns Hopkins Eastern Campus; 🇺🇸 Baltimore, Maryland, United States