Virtual Reality to Enhance Upper Extremity Physical Therapy and Recovery

This is a descriptive study assessing the feasibility of using VR rehabilitation with unilateral (or bilateral) impairment of the arm, wrist and or hand resulting in reduced range of motion, dexterity, and/or strength of the hand.

Study Overview

• Status: Recruiting
• Conditions: Injuries to the Hand and Wrist
• Intervention / Treatment: Device: Meta Quest 2

Detailed Description

The purpose of this study is to determine the feasibility of using a virtual reality program to monitor and encourage compliance with musculoskeletal home exercise programs. It hypothesizes that the treatment will display improved compliance, range of motion, and general function for individuals with upper extremity musculoskeletal deficits.

The primary objectives are to: 1. Describe participant compliance with an immersive game-based virtual reality (VR) rehabilitation device for delivering at-home occupational therapy exercises for the wrist and hand in individuals with motor impairments. 2. Describe and compare functional outcomes among participants before and after completing at-home rehabilitation using the VR system.

These objective outcomes will be measured through various standardized tests completed by qualified study team members.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David C Carlisle, BA; Phone Number: (240)626-6964; Email: david.carlisle.ctr@usuhs.edu
• Study Contact Backup: Name: Michelle J Nordstrom; Email: michelle.j.nordstrom.civ@health.mil

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Recruiting
      • Walter Reed National Military Medical Center
      • Contact: Michelle L Luken, DSc; Phone Number: 410-952-9106; Email: michelle.l.luken.ctr@health.mil
      • Contact: Tiffany R Riggleman, AAS; Phone Number: (301)707-9681; Email: tiffany.r.riggleman.ctr@health.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• DoD Beneficiary
• Exhibiting musculoskeletal impairment requiring continued at-home rehabilitation
• Cleared by research or clinical medical provider for participation
• Participant no longer has active range of motion movement restrictions. They may still have weight bearing restrictions but nothing that will preclude them from moving their hand and digits to their maximum ability.
• Ability to keep hand and arm in the field of view of the VR scene
• Must have demonstrated the ability for the Oculus to track all hand and wrist motions of interest (during an initial screening at baseline)
• Ability to independently don and doff the VR headset, plus start the app (verified in the Occupational Therapy/Physical Therapy clinic)
• Age range between 18-65
• Demonstrate the ability to tolerate wearing the VR headset

Exclusion Criteria:

• History of photo-induced seizures
• History of motion sickness when using VR equipment (especially vestibular effects such as nausea, dizziness, etc.)
• Partial amputations of the arm being assessed (including missing digits as they may not enable tracking by the VR)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual Reality to Enhance Upper Extremity Physical Therapy and Recovery; This is a descriptive study assessing the feasibility of using VR rehabilitation with unilateral (or bilateral) impairment of the arm, wrist, and or hand resulting in reduced range of motion, dexterity, and/or strength of the hand. Phase I: Typical Home Exercise Program, Phase II: Use of VR headset in conjunction with current Home Exercise Program. Intervention sessions include the baseline, midpoint and final visits.

Device: Meta Quest 2; The Meta/Oculus Quest (along with the SignWave software) delivers an immersive audio/visual-based game environment where the users hand is created and displayed in the virtual environment and matches target gestures to the beat of the music.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Jebsen-Taylor Hand Function Test	Assessment of functional use and selection of appropriate grasp for common activities of daily living	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
9-hole Peg Test	Speed and accuracy of grasp and release	10 minutes
Hand/wrist goniometric range of motion (ROM)	Hand/wrist range of motion assessment	15 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire	Self-reported perception of functional ability of arm, shoulder, and hand	5 minutes
NASA-TLX	Ease of use preference and mental load survey	5 minutes
System Usability Scale	Quantitative ease of use assessment	2 minutes
Open-Ended Usability Scale	Qualitative ease of use assessment	2 minutes

Collaborators and Investigators

• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborators: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Estimate): May 5, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: virtual reality; hand; therapy; immersive; take-home
• Other Study ID Numbers: WRNMMC-2021-0376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes