Pilot Project to Evaluate the Revolutionizing Prosthetics Modular Prosthetic Limb System for Upper Extremity Amputees

Not Applicable

• Conditions: Prosthesis Use; Limb Loss
• Interventions: Device: Modular Prosthetic Limb

• Registration Number: NCT02887690
• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Brief Summary

The purpose of this study is to optimize the Defense Advanced Research Projects Agency's (DARPA) advanced upper limb prosthesis, the Modular Prosthetic Limb (MPL), by evaluating the performance, usability, and patient acceptance of the MPL in a clinical setting. This study will be a non-randomized limited clinical optimization study. The study will consist of two phases. Up to twenty-four upper extremity amputees will be recruited in order to ensure twelve subjects for participation in the study: 6 trans-humeral amputees and 6 trans-radial amputees. During Phase 1, subjects will be evaluated for their potential to operate the MPL using a virtual limb controlled by signals from surface electromyograms (sEMG). The first six trans-humeral amputee subjects and the first six trans-radial amputee subjects with a demonstrated proficiency controlling the MPL based on analytical performance metrics will enter Phase 2. During Phase 2, each subject will be fitted for the prosthesis with a custom socket. The user will then evaluate the prosthesis during twelve 1- hour or 1 and one half-hour sessions, working with an occupational therapist and research associates and completing both quantitative and qualitative assessments.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-02
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-15
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modular Prosthetic Limb	Modular Prosthetic Limb	The Defense Advanced Research Projects Agency's (DARPA) advanced upper limb prosthesis, the Modular Prosthetic Limb (MPL)

Primary Outcome Measures

Name	Time	Method
MPL functionality during clinical use	From beginning to end of clinical testing period, evaluated up to four weeks	The overall objective of the study is to determine the functionality of the MPL during clinical use in training scenarios simulating activities of daily living, and to assess patient satisfaction of the MPL by individuals with upper extremity amputations. The results will be used to optimize control and features of the MPL based on qualitative and quantitative user driven feedback in a clinical setting.

Secondary Outcome Measures

Name	Time	Method
Optimally controlled degrees of freedom	From beginning to end of clinical testing period, evaluated up to four weeks	We will functionally assess the number of optimally controlled degrees of freedom by having users perform comparative assessments using their existing prosthesis as a baseline, followed the MPL configured with increasing number of controllable degrees of freedom to accomplish functional activities of daily living.

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States