ClinicalTrials.Veeva

Menu

Virtual Reality Prosthetic Training and Rehabilitation

University of South Florida logo

University of South Florida

Status and phase

Completed
Early Phase 1

Conditions

Amputation of Upper Limb

Treatments

Device: Virtual Reality

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02666859
Pro00016934

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Device Feasibility

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Unilateral Transradial Amputation
Experimental group
Description:
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.
Treatment:
Device: Virtual Reality
Unilateral Transhumeral Amputation
Experimental group
Description:
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.
Treatment:
Device: Virtual Reality

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems