Virtual Reality Prosthetic Training and Rehabilitation

NCT ID: NCT02666859

Last Updated: 2019-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-06-30

Brief 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.

Conditions

Amputation of Upper Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Unilateral Transradial Amputation

This group includes people with a unilateral transradial amputation. Potential subjects must use a body-powered or myoelectric prosthetic device. This group will be exposed to virtual reality therapy and non-virtual reality therapy.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: 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.

Unilateral Transhumeral Amputation

This group includes people with a unilateral transhumeral amputation. Potential subjects must use a body-powered or myoelectric prosthetic device. This group will be exposed to virtual reality therapy and non-virtual reality therapy.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: 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.

Interventions

Virtual Reality

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Telemedicine & Advanced Technology Research Center

OTHER

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Stephanie L. Carey

Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashley Knight, M.S. BME

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Stephanie Carey, Ph.D. BME

Role: STUDY_DIRECTOR

University of South Florida

Locations

University of South Florida

Tampa, Florida, United States

Countries

United States

Other Identifiers

Pro00016934

Identifier Type: -

Identifier Source: org_study_id