Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT06832527
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-20
First Post:
2025-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Virtual Reality to Improve Sensorimotor Function in Patients with Traumatic Wrist and Hand Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014954', 'term': 'Wrist Injuries'}], 'ancestors': [{'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 79}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-02-13', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proprioception', 'timeFrame': 'Baseline, 1 and 3 months', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Kinesiophobia', 'timeFrame': 'Baseline, 1 and 3 months', 'description': "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."}, {'measure': 'Catastrophism', 'timeFrame': 'Baseline, 1 and 3 months', 'description': "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."}, {'measure': 'Function', 'timeFrame': 'Baseline, 1 and 3 months', 'description': '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.'}, {'measure': 'Hand and Wrist function', 'timeFrame': 'Baseline, 1 and 3 months', 'description': '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.'}, {'measure': 'Range of motion', 'timeFrame': 'Baseline, 1 and 3 months', 'description': 'Range of motion of the wrist and fingers using a goniometer.'}, {'measure': 'Force Sense', 'timeFrame': 'Baseline, 1 and 3 months', 'description': "GRIP's force sense assessed with Force Sense Test (FST), where punctuation is the difference between the asked and replicated force."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wrist injury', 'proprioception', 'virtual reality'], 'conditions': ['Wrist Injury']}, 'descriptionModule': {'briefSummary': '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:\n\n* Evaluate the effect of using virtual reality added to standard rehabilitation of wrist injuries in proprioception impairment.\n* Evaluate the effect of using virtual reality on psychological factors as kinesiophobia and catastrofism.\n* Evaluate the effect of using virtual reality in functionality on wrist-injured patients.\n\nIntervention will be:\n\n* Control group: participants of this group will receive conventional rehabilitation of the wrist, plus a specific proprioceptive exercise program.\n* 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.\n\nResearchers will compare control and experimental group to see if an implantation of Virtual Reality could had benefits on function, kinesiophobia, catastrofism and proprioception.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (equal or more than 18 y/o).\n* Suffering wrist injury\n* Agree and sign informed consent.\n\nExclusion Criteria:\n\n* Not had suffered a wrist injury\n* Suffer from any mental, cognitive, neurological or musculoskeletal disorder\n* Have cervical pathology/impairment\n* Have visual or balance problems'}, 'identificationModule': {'nctId': 'NCT06832527', 'briefTitle': 'Use of Virtual Reality to Improve Sensorimotor Function in Patients with Traumatic Wrist and Hand Injuries', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaga'}, 'officialTitle': 'Use of Virtual Reality to Improve Sensorimotor Function in Patients with Traumatic Wrist and Hand Injuries', 'orgStudyIdInfo': {'id': 'VirtualReality-pp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional rehabilitation', 'description': 'Conventional rehabilitation treatment for the wrist plus a specific proprioceptive exercise program.', 'interventionNames': ['Other: Rehabilitation treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Rehabilitation+virtual reality', 'description': 'Conventional rehabilitation treatment for the wrist plus a specific proprioceptive exercise program and virtual reality games', 'interventionNames': ['Other: Rehabilitation treatment', 'Other: Virtual Reality games']}], 'interventions': [{'name': 'Rehabilitation treatment', 'type': 'OTHER', 'description': 'ROM, strength, stretch and proprioception exercises', 'armGroupLabels': ['Conventional rehabilitation', 'Rehabilitation+virtual reality']}, {'name': 'Virtual Reality games', 'type': 'OTHER', 'description': 'Virtual Reality games using META QUEST PRO glasses', 'armGroupLabels': ['Rehabilitation+virtual reality']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaga', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Occupational therapist', 'investigatorFullName': 'Leire Cruz-Gambero', 'investigatorAffiliation': 'University of Malaga'}}}}