Virtual Reality Prosthetic Training and Rehabilitation
Condition: Amputation of Upper Limb
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The proposed project is to develop an effective prosthetic training and rehabilitation
      regimen, with the use of virtual reality, to return patients to the highest level of
      independence and functioning possible. The Computer Assisted Rehabilitation Environment
      (CAREN) system (Motek Medical, Netherlands) will be used to immerse patients into real life
      situations while providing real time visual feedback of their motion to improve the training
      and rehabilitation of upper limb prosthetic users.
    

Detailed description: 
      The subjects will be asked to participate in two 1-2 hour sessions to test the range of
      motion (ROM), activities of daily living ( ADL) and return to duty tasks (RTD) tasks with and
      without the use of virtual reality. All amputee subjects will be required to wear their same
      preferred prosthetic device for all sessions. The ROM tasks include, elbow flexion/extension,
      forearm pronation/supination, shoulder flexion/extension, shoulder abduction/adduction,
      shoulder rotation, torso flexion/extension, torso lateral flexion, and torso rotation. The
      ADL tasks would include a series of tasks to encompass typical actives one would encounter on
      a daily basis such as, drinking from a cup, bilateral and unilateral lift tasks, and a reach
      and grasp test. The RTD tasks would include a series of simple tasks service members
      typically perform in their daily work routine such as donning and doffing a jacket and
      helmet, packing and unpacking a rucksack, and carrying a weapon.

      The subjects will be asked to complete each task three times. Prior to performing a task,
      when participating in the virtual reality session, the task will be demonstrated on the
      virtual screen with an animated model. The motion of the animated model will be determined by
      previously collected data to accurately predict the correct motion for each individual. An
      avatar of the subject will then be shown on the screen to display the real time motion. The
      reflective markers that were strategically placed on the subject will be connected to the
      corresponding joint on the virtual avatar to accurately animate the real time motion of the
      subject on the virtual screen. The demonstrated model will be shown simultaneously with the
      real time avatar to show the accuracy of the subject's performance in relation to the
      individualized predicted optimized motion. This will provide instant visual feedback to the
      subject.
    

Intervention name(s): Virtual Reality
Intervention type(s): Device
Intervention description(s): During this intervention, the subjects will be immersed in a virtual reality system called the Computer Assisted Rehabilitation Environment (CAREN) system to complete the tasks.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Virtual Reality Prosthetic Training
Masking: None (Open Label)
Primary purpose: Device Feasibility