Injuries to the Hand and WristNCT05846464
Virtual Reality to Enhance Upper Extremity Physical Therapy and Recovery
A study testing Meta Quest 2 in people with Injuries to the Hand and Wrist, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Injuries to the Hand and Wrist
- What is being tested?
- Meta Quest 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
About this study
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.
Read the 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
- Being tested
- Meta Quest 2
- Keywords
- virtual reality, hand, therapy, immersive, take-home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meta Quest 2Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality to Enhance Upper Extremity Physical Therapy and Recovery | Experimental | 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. Receives: Device: Meta Quest 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jebsen-Taylor Hand Function Test
Assessment of functional use and selection of appropriate grasp for common activities of daily living
Measured: 30 minutes
Secondary outcomes (2)
9-hole Peg Test
Speed and accuracy of grasp and release
Measured: 10 minutes
Hand/wrist goniometric range of motion (ROM)
Hand/wrist range of motion assessment
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start13 Mar 2023
- Primary completion30 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injuries to the Hand and WristStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Walter Reed National Military Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846464
- Sponsor's protocol ID
- WRNMMC-2021-0376
- Status last verified
- Mar 2025
- First submitted
- 27 Apr 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality to Enhance Upper Extremity Physical Therapy and Recovery
- ClinicalTrials.gov ID
- NCT05846464
- Acronym / sponsor ID
- WRNMMC-2021-0376
- Conditions
- Injuries to the Hand and Wrist
- Keywords
- virtual reality, hand, therapy, immersive, take-home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Walter Reed National Military Medical Center
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality to Enhance Upper Extremity Physical Therapy and Recovery | Experimental | Device: Meta Quest 2This 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meta Quest 2The 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. | Device | Virtual Reality to Enhance Upper Extremity Physical Therapy and Recovery |
Primary outcome
Jebsen-Taylor Hand Function Test
Time frame: 30 minutes
Assessment of functional use and selection of appropriate grasp for common activities of daily living
2 secondary outcomes
9-hole Peg Test
Time frame: 10 minutes
Hand/wrist goniometric range of motion (ROM)
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Injuries to the Hand and Wrist
Active, not recruiting
GaMA Metric to Quantify Functional Importance of Various Upper Limb Prosthetic Devices
Amputation, Amputation, Traumatic
Active, not recruiting
VR to Evaluate Phantom Limb Pain
Phantom Limb Pain, Phantom Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meta Quest 2 in people with Injuries to the Hand and Wrist, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jebsen-Taylor Hand Function Test (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.