Clinical trial NCT02666859: Virtual Reality Prosthetic Training and Rehabilitation
Official title: The Use of Virtual Reality to Enhance Upper Limb Prosthetic Training and Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Amputation of Upper Limb
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
name: Telemedicine & Advanced Technology Research Center
First posted: 2016-01-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Virtual Reality Prosthetic Training
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Joint Angle Range of Motion
timeFrame: 2 hours
Secondary outcomes:
measure: Movement Symmetry
timeFrame: 2 hours
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Ashley Knight, M.S. BME
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Stephanie Carey, Ph.D. BME
role: STUDY_DIRECTOR
References: