NCT06832527

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

1 month

First QC Date

February 13, 2025

Last Update Submit

February 18, 2025

Conditions

Keywords

wrist injuryproprioceptionvirtual reality

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 1 and 3 months

Secondary Outcomes (6)

  • Kinesiophobia

    Baseline, 1 and 3 months

  • Catastrophism

    Baseline, 1 and 3 months

  • Function

    Baseline, 1 and 3 months

  • Hand and Wrist function

    Baseline, 1 and 3 months

  • Range of motion

    Baseline, 1 and 3 months

  • +1 more secondary outcomes

Study Arms (2)

Conventional rehabilitation

ACTIVE COMPARATOR

Conventional rehabilitation treatment for the wrist plus a specific proprioceptive exercise program.

Other: Rehabilitation treatment

Rehabilitation+virtual reality

EXPERIMENTAL

Conventional rehabilitation treatment for the wrist plus a specific proprioceptive exercise program and virtual reality games

Other: Rehabilitation treatmentOther: Virtual Reality games

Interventions

ROM, strength, stretch and proprioception exercises

Conventional rehabilitationRehabilitation+virtual reality

Virtual Reality games using META QUEST PRO glasses

Rehabilitation+virtual reality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wrist Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational therapist

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 18, 2025

Study Start

February 25, 2025

Primary Completion

April 1, 2025

Study Completion

July 1, 2025

Last Updated

February 20, 2025

Record last verified: 2025-02