Wrist InjuryNCT06832527
Use of Virtual Reality to Improve Sensorimotor Function in Patients with Traumatic Wrist and Hand Injuries
A study testing Rehabilitation treatment and Virtual Reality games in people with Wrist Injury, run by University of Malaga.
Trial summary
The goal of this randomized clinical trial is to compare how the incorporation of Virtual Reality could influence in proprioception, kinesiophobia, functionality and catastrophism in people that are undergoing a rehabilitation treatment after a wrist fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Injury
- What is being tested?
- Rehabilitation treatment and Virtual Reality games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2025to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (equal or more than 18 y/o).
- Suffering wrist injury
- Agree and sign informed consent.
Who cannot join
- Not had suffered a wrist injury
- Suffer from any mental, cognitive, neurological or musculoskeletal disorder
- Have cervical pathology/impairment
- Have visual or balance problems
About this study
The goal of this randomized clinical trial is to compare how the incorporation of Virtual Reality could influence in proprioception, kinesiophobia, functionality and catastrophism in people that are undergoing a rehabilitation treatment after a wrist fracture. The principal questions it aims to answer are:
- Evaluate the effect of using virtual reality added to standard rehabilitation of wrist injuries in proprioception impairment.
- Evaluate the effect of using virtual reality on psychological factors as kinesiophobia and catastrofism.
- Evaluate the effect of using virtual reality in functionality on wrist-injured patients.
Read more
Intervention will be:
- Control group: participants of this group will receive conventional rehabilitation of the wrist, plus a specific proprioceptive exercise program.
- Experimental group: participants of this group will receive the same treatment as the control group but adding virtual reality games at the end of the session.
Researchers will compare control and experimental group to see if an implantation of Virtual Reality could had benefits on function, kinesiophobia, catastrofism and proprioception.
- Conditions
- Wrist Injury
- Being tested
- Rehabilitation treatment, Virtual Reality games
- Keywords
- wrist injury, proprioception, virtual reality
- Medical subject headings
- Wrist Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation treatmentOther
ROM, strength, stretch and proprioception exercises
Virtual Reality gamesOther
Virtual Reality games using META QUEST PRO glasses
| Study group | Role | What they receive |
|---|---|---|
| Conventional rehabilitation | Active comparator | Conventional rehabilitation treatment for the wrist plus a specific proprioceptive exercise program. Receives: Other: Rehabilitation treatment |
| Rehabilitation+virtual reality | Experimental | Conventional rehabilitation treatment for the wrist plus a specific proprioceptive exercise program and virtual reality games Receives: Other: Rehabilitation treatment; Other: Virtual Reality games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proprioception
Assessment of proprioception impairment using Joint Position Sense Test (JPST). Punctuation will be the difference between the asked position and the patient's replication. The test will be repeated with open and closed eyes.
Measured: Baseline, 1 and 3 months
Secondary outcomes (6)
Kinesiophobia
Fear of movement, assessed with Tampa Scale for Kinesiophobia (TSK) which has 17 items with Likert's answers. Punctuation goes from 17 to 68 points, where <37 points means a low level of kinesiophobia and >37 a high level.
Measured: Baseline, 1 and 3 months
Catastrophism
Catastrophizing pain assessed with Pain Catasthrophizing Scale (PCS) which has 13 items with Likert's answers. Punctuation goes from 0 to 52 points, where 0-20 points means a low catastrophism, 21-30 points moderate catastrophism and >30 points a high catastrophism.
Measured: Baseline, 1 and 3 months
Function
Functionality of the upper limb assessed with QuickDASH which has 11 items. Punctuation goes from 0 to 100, where 0 means no disability and 100 maximum disability.
Measured: Baseline, 1 and 3 months
Hand and Wrist function
Assessed with Patient-Rated Wrist Evaluation (PRWE) which has 15 items punctuated from 0 to 10. Punctuation goes from 0-100 where 0 means no disability and 100 maximum disability.
Measured: Baseline, 1 and 3 months
Range of motion
Range of motion of the wrist and fingers using a goniometer.
Measured: Baseline, 1 and 3 months
Force Sense
GRIP's force sense assessed with Force Sense Test (FST), where punctuation is the difference between the asked and replicated force.
Measured: Baseline, 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start25 Feb 2025 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist InjuryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leire Cruz-Gambero, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832527
- Sponsor's protocol ID
- VirtualReality-pp
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality to Improve Sensorimotor Function in Patients with Traumatic Wrist and Hand Injuries
- ClinicalTrials.gov ID
- NCT06832527
- Acronym / sponsor ID
- VirtualReality-pp
- Conditions
- Wrist Injury
- Keywords
- wrist injury, proprioception, virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 25 Feb 2025 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 18 Feb 2025 (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.
The goal of this randomized clinical trial is to compare how the incorporation of Virtual Reality could influence in proprioception, kinesiophobia, functionality and catastrophism in people that are undergoing a rehabilitation treatment after a wrist fracture. The principal questions it aims to answer are:
- Evaluate the effect of using virtual reality added to standard rehabilitation of wrist injuries in proprioception impairment.
- Evaluate the effect of using virtual reality on psychological factors as kinesiophobia and catastrofism.
- Evaluate the effect of using virtual reality in functionality on wrist-injured patients.
Intervention will be:
- Control group: participants of this group will receive conventional rehabilitation of the wrist, plus a specific proprioceptive exercise program.
- Experimental group: participants of this group will receive the same treatment as the control group but adding virtual reality games at the end of the session.
Researchers will compare control and experimental group to see if an implantation of Virtual Reality could had benefits on function, kinesiophobia, catastrofism and proprioception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional rehabilitation | Active comparator | Other: Rehabilitation treatmentConventional rehabilitation treatment for the wrist plus a specific proprioceptive exercise program. |
| Rehabilitation+virtual reality | Experimental | Other: Rehabilitation treatment, Other: Virtual Reality gamesConventional rehabilitation treatment for the wrist plus a specific proprioceptive exercise program and virtual reality games |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (equal or more than 18 y/o).
- Suffering wrist injury
- Agree and sign informed consent.
Key exclusion criteria (4 listed)
- Not had suffered a wrist injury
- Suffer from any mental, cognitive, neurological or musculoskeletal disorder
- Have cervical pathology/impairment
- Have visual or balance problems
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 |
|---|---|---|
| Rehabilitation treatmentROM, strength, stretch and proprioception exercises | Other | Conventional rehabilitation, Rehabilitation+virtual reality |
| Virtual Reality gamesVirtual Reality games using META QUEST PRO glasses | Other | Rehabilitation+virtual reality |
Primary outcome
Proprioception
Time frame: Baseline, 1 and 3 months
Assessment of proprioception impairment using Joint Position Sense Test (JPST). Punctuation will be the difference between the asked position and the patient's replication. The test will be repeated with open and closed eyes.
6 secondary outcomes
Kinesiophobia
Time frame: Baseline, 1 and 3 months
Catastrophism
Time frame: Baseline, 1 and 3 months
Function
Time frame: Baseline, 1 and 3 months
Hand and Wrist function
Time frame: Baseline, 1 and 3 months
Range of motion
Time frame: Baseline, 1 and 3 months
Force Sense
Time frame: Baseline, 1 and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation treatment and Virtual Reality games in people with Wrist Injury, run by University of Malaga.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Proprioception (time frame: Baseline, 1 and 3 months). 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 20 Feb 2025.