Virtual Reality Prosthetic Training and Rehabilitation

NCT02666859 | Completed Early Phase 1 DMC

• 1 other identifier: Pro00016934
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation of Upper Limb

Outcome Measures

Primary Outcomes (1)

• Joint Angle Range of Motion

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

  2 hours

Secondary Outcomes (1)

• Movement Symmetry

  2 hours

Study Arms (2)

Unilateral Transradial Amputation

EXPERIMENTAL

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.

Device: Virtual Reality

Unilateral Transhumeral Amputation

EXPERIMENTAL

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.

Device: Virtual Reality

Interventions

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.

Unilateral Transhumeral Amputation; Unilateral Transradial Amputation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead
• U.S. Army Medical Research and Development Command: collaborator
• Telemedicine & Advanced Technology Research Center: collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

Location

Study Officials

• Ashley Knight, M.S. BME

  University of South Florida

  PRINCIPAL INVESTIGATOR

• Stephanie Carey, Ph.D. BME

  University of South Florida

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Model Details: Virtual Reality Prosthetic Training

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 28, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 12, 2019

Record last verified: 2019-07

Locations

US (1)