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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

79

Phase

  • 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

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
Intervention / Treatment
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

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

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

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)

February 25, 2025

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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