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OpenTrials
Completed

NCT Number: NCT02666859

Virtual Reality Prosthetic Training and Rehabilitation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of South Florida

Tampa, Florida, 33620, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with unilateral transhumeral or transradial amputation
  • uses body-powered or myoelectric prosthetic device.
  • free of any health aliment that would impair physical function
  • must not have any injuries or surgeries on the affected limb within the past 90 days.
  • Subjects ,just be able to perform activities of daily living without assistance

Treatment and study plan

Virtual reality

Device

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.

Primary outcomes

  1. Joint Angle Range of Motion

    Time frame: 2 hours

    Using a motion capture system, joint angle measurements will be taken throughout the sessions while the subject completes the tasks.

Secondary outcomes

  1. Movement Symmetry

    Time frame: 2 hours

    Using a motion capture system and the joint angle measurements, the movement symmetry of the arms will be calculated.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • Telemedicine & Advanced Technology Research Center
  • U.S. Army Medical Research and Development Command

Registry information

Official study title

The Use of Virtual Reality to Enhance Upper Limb Prosthetic Training and Rehabilitation

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2016
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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