Virtual Reality-based Rehabilitation for Traumatic Hand and Wrist Injuries

NCT07633769 | Recruiting

• 2 other identifiers: UMA-VR-HAND-2026-003CEUMA 24-2025-H
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of immersive virtual reality (VR)-based Action Observation Therapy (AOT) as an adjunct to conventional rehabilitation in patients with traumatic wrist and hand injuries. Participants will receive standard rehabilitation treatment, and the intervention group will additionally undergo a six-week VR program involving observation and execution of functional hand and wrist movements. Outcomes related to hand function, grip strength, pain, proprioception, disability, and psychological factors will be assessed to determine the potential benefits of incorporating VR into rehabilitation programs.

Conditions

Wrist Injury; Hand and Upper Limb Trauma; Hand and Forearm Trauma; Muskuloskeletal Diseases

Keywords

Virtual Reality; Upper limb rehabilitation; Sensorimotor Function; Functional recovery

Outcome Measures

Primary Outcomes (9)

• Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score

  Self-reported upper limb disability assessed with QuickDASH questionnaire (0-100, higher scores indicate greater disability).

  Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention

• Patient-Rated Wrist and Hand Evaluation (PRWHE) Total Score

  Wrist and hand pain and function assessed with the PRWHE questionnaire (0-100, lower scores indicate better outcomes).

  Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.

• Michigan Hand Outcomes Questionnaire (MHQ) Total Score

  Hand-specific function, pain, activities of daily living, work performance, aesthetics and satisfaction assessed with the MHQ (0-100 scale).

  Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.

• Shoulder Pain and Disability Index (SPADI) Total Score

  Shoulder pain and disability assessed with SPADI questionnaire (0-100, lower scores indicate better outcomes).

  Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.

• Pain Catastrophizing scale (PCS) Total Score

  Maladaptive pain-related cognitions assessed with the PCS (0-52, higher scores indicate greater catastrophizing).

  Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.

• Tampa Scale for Kinesiophobia (TSK-11) Total Score

  Fear of movement assessed with the TSK-11 questionnaire (11-44, higher scores indicate greater kinesiophobia).

  Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.

• Active Wrist range of motion (degrees)

  Active wrist flexion, extension, radial deviation, ulnar deviation, pronation and supination measured with a universal goniometer (degrees).

  Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.

• Grip strength (Kg)

  Grip strength measured in kilograms using a Jamar dynamometer in standardized position.

  Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.

• Wrist joint position sense error (Degrees)

  Proprioceptive accuracy assessed as the mean absolute angular error (degrees) between a target wrist joint position set by the examiner and the position actively reproduced by the participant with eyes closed. Lower values indicate better proprioceptive accuracy.

  Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.

Other Outcomes (2)

• Incidence of virtual reality - related adverse events

  From firsts intervention session through final intervention session (approximately 6 weeks).

• Intervention adherence

  From firsts intervention session through final intervention session (approximately 6 weeks).

Study Arms (2)

RV Group

EXPERIMENTAL

Patients will receive conventional rehabilitation for traumatic wrist and hand injuries in addition to immersive virtual reality-based Action Observation Therapy (AOT). The virtual reality intervention consists of observation and execution of functional wrist and hand movements using a head-mounted display, delivered twice weekly for six weeks.

Behavioral: Immersive Virtual Reality Action Observation Therapy

Hand Therapy Group

ACTIVE COMPARATOR

Patients will receive conventional rehabilitation including active and passive mobilization, progressive strengthening exercises, functional re-education, and pain management according to the stage of recovery.

Other: Conventional Rehabilitation

Interventions

Immersive Virtual Reality Action Observation Therapy BEHAVIORAL

Participants observe and subsequently perform functional wrist and hand movements within immersive virtual reality environments using a Meta Quest Pro headset. The intervention is delivered twice weekly for six weeks, with sessions lasting approximately 45 minutes.

Also known as: IVR group

RV Group

Conventional Rehabilitation OTHER

Standard rehabilitation program for traumatic wrist and hand injuries including active and passive mobilization, strengthening exercises, functional training, and pain management.

Also known as: CR group

Hand Therapy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Diagnosis of a traumatic wrist and/or hand injury.
• Referred for rehabilitation treatment at the participating hand therapy unit.
• Ability to understand study procedures and provide written informed consent.
• Ability to participate in the virtual reality intervention.

You may not qualify if:

• Previous injury affecting the same hand.
• Associated upper-limb conditions, including tenosynovitis or Dupuytren's disease.
• Previous surgery involving the affected hand before the current traumatic injury.
• Corticosteroid or other therapeutic injection in the affected hand within the previous 3 weeks.
• Any physical, neurological, visual, vestibular, or medical condition that prevents safe use of the virtual reality device.
• Inability to comply with the study procedures or assessments.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

UMA

Málaga, 29071, Spain

RECRUITING

MeSH Terms

Conditions

Wrist Injuries

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants will be anonymized with a number and randomized with a web program (random.org)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

ES (1)