Use of Virtual Reality to Improve Sensorimotor Function in Patients with Traumatic Wrist and Hand Injuries

February 18, 2025 updated by: Leire Cruz-Gambero, University of Malaga

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult (equal or more than 18 y/o).
  • Suffering wrist injury
  • Agree and sign informed consent.

Exclusion Criteria:

  • Not had suffered a wrist injury
  • Suffer from any mental, cognitive, neurological or musculoskeletal disorder
  • Have cervical pathology/impairment
  • Have visual or balance problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional rehabilitation
Conventional rehabilitation treatment for the wrist plus a specific proprioceptive exercise program.
Other: Rehabilitation treatment
ROM, strength, stretch and proprioception exercises
Experimental: Rehabilitation+virtual reality
Conventional rehabilitation treatment for the wrist plus a specific proprioceptive exercise program and virtual reality games
Other: Rehabilitation treatment
ROM, strength, stretch and proprioception exercises
Other: Virtual Reality games
Virtual Reality games using META QUEST PRO glasses

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Kinesiophobia
Time Frame: Baseline, 1 and 3 months
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.
Baseline, 1 and 3 months
Catastrophism
Time Frame: Baseline, 1 and 3 months
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.
Baseline, 1 and 3 months
Function
Time Frame: Baseline, 1 and 3 months
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.
Baseline, 1 and 3 months
Hand and Wrist function
Time Frame: Baseline, 1 and 3 months
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.
Baseline, 1 and 3 months
Range of motion
Time Frame: Baseline, 1 and 3 months
Range of motion of the wrist and fingers using a goniometer.
Baseline, 1 and 3 months
Force Sense
Time Frame: Baseline, 1 and 3 months
GRIP's force sense assessed with Force Sense Test (FST), where punctuation is the difference between the asked and replicated force.
Baseline, 1 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VirtualReality-pp

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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