Clinical trial NCT05846464: Virtual Reality to Enhance Upper Extremity Physical Therapy and Recovery
Official title: Virtual Reality to Enhance Upper Extremity Physical Therapy and Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injuries to the Hand and Wrist
Keywords: virtual reality
hand
therapy
immersive
take-home
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Walter Reed National Military Medical Center
First posted: 2023-05-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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)

Primary outcomes:
measure: Jebsen-Taylor Hand Function Test
timeFrame: 30 minutes
Secondary outcomes:
measure: 9-hole Peg Test
timeFrame: 10 minutes
measure: Hand/wrist goniometric range of motion (ROM)
timeFrame: 15 minutes
Other outcomes:
measure: Quick DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire
timeFrame: 5 minutes
measure: NASA-TLX
timeFrame: 5 minutes
measure: System Usability Scale
timeFrame: 2 minutes
measure: Open-Ended Usability Scale
timeFrame: 2 minutes
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
References: