Virtual Reality-based Rehabilitation for Traumatic Hand and Wrist Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Malaga
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Immersive Virtual Reality Action Observation Therapy
BehavioralParticipants 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.
Conventional Rehabilitation
Other interventionStandard rehabilitation program for traumatic wrist and hand injuries including active and passive mobilization, strengthening exercises, functional training, and pain management.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: RV GroupExperimental treatment 1 intervention
Group B: Hand Therapy GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention2
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).
Time frame
Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.3
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).
Time frame
Baseline (approximately 5 days after immobilization removal), week 6 (beginning of the sixth week of intervention), and 3 months after completion of the intervention.4
Shoulder Pain and Disability Index (SPADI) Total Score
Shoulder pain and disability assessed with SPADI questionnaire (0-100, lower scores indicate better outcomes).
Time frame
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
1
Incidence of virtual reality - related adverse events
Number of participants experiencing dizziness, nausea, visual discomfort, or disorientation during intervention sessions.
Time frame
From firsts intervention session through final intervention session (approximately 6 weeks).2
Intervention adherence
Percentage of prescribed sessions completed by each participant.
Time frame
From firsts intervention session through final intervention session (approximately 6 weeks).Sponsors and contacts
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Source ClinicalTrials.gov