Comparison of Pattern Recognition Control and Direct Control in TMR
Condition: Amputation; Amputation; Traumatic, Arm, Upper
MeSH terms: Amputation, Traumatic
Study type: Interventional

Summary: 
      Targeted Muscle Reinnervation increases the control signals available for commercial arm
      systems. A new type of control, pattern recognition, has been developed into a form that
      allows use with commercially available arm system. The goal of this project is a home trial,
      in which people who have had TMR will try the new controls and the new arm to find out if
      they are better than what is currently available. Home trials will also allow us to see what
      needs to be done to make our inventions work even better.
    

Detailed description: 
      Subjects who participate return to RIC several times (approximately 6-8 times) to undergo any
      necessary training and testing. Each visit will last from 2-5 days. The study will include
      use of up to three different prosthesis control systems at home for approximately 6 weeks
      each. The order of the systems will be randomized.

      The first visit will allow us to cast the subject's residual limb for a socket and measure
      for a gel liner to be made with embedded electrode contacts prior to the next return. The
      socket interface will be fit for optimal comfort and a suspension sleeve and/or other straps,
      fasters, etc to best hold the prosthesis securely on the residual limb for the activities
      required. Unless changes are needed due to changes in limb volume, the same socket can be
      used for all phases of the study. During the initial and subsequent visits, subjects may
      practice the various control methods using a virtual reality system. EMG data and virtual
      "games" will be used to practice the control and will provide quantitative data that can be
      used to assess the various control methods mathematically, without the prosthesis.

      Each phase of the study (up to 4 phases), will include preliminary training and testing at
      RIC lasting for 1-5 days, followed by approximately 6 weeks of at-home use of the system.
      After this time subjects will return to the RIC for 2-3 days of testing. They will then be
      trained and pre-tested in use of the next control during the same visit or at a later date.
      These systems include a commercially available myoelectric prosthesis with standard control,
      a commercially available device with advanced control (called pattern recognition), a
      commercially available device with pattern recognition and a new electrode configuration.
      Photographs or video recordings will be made during participation in this research study.
      These pictures and video recordings are essential for proper data analysis.

      During the at-home use periods subjects will go about their daily business using the test
      prosthesis and will be asked document the experience with the prosthesis via weekly phone
      communication with study staff. Dates/times will be coordinated during normal business hours
      At the end of the at-home use period subjects will return to RIC for 3-5 days, where they
      will be asked to complete a questionnaire about how the prosthesis worked, and will undergo
      some non-invasive testing to see how well they can control and use the prosthesis.
    

Intervention name(s): Commercial system; RIC arm system; Direct Control; Pattern Recognition
Intervention type(s): Device; Device; Other; Other
Intervention description(s): Transhumeral amputees who have had TMR will use a commercially available prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct and pattern recognition - based control.; Transhumeral amputees who have had TMR will use the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct and pattern recognition - based control.; Transhumeral amputees who have had TMR will use either a commercially available prosthesis or the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct control.; Transhumeral amputees who have had TMR will use either a commercially available prosthesis or the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for pattern recognition control.
Allocation: Randomized
Intervention model: Single Group Assignment
Primary purpose: Basic Science