Virtual Reality to Enhance Upper Extremity Physical Therapy and Recovery

NCT ID: NCT05846464

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2023-12-01

Brief Summary

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.

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.

Conditions

Injuries to the Hand and Wrist

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Meta Quest 2

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

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

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

WRNMMC-2021-0376

Identifier Type: -

Identifier Source: org_study_id