Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:39 AM
Study NCT ID:
NCT07478835
Status:
COMPLETED
Last Update Posted:
2026-03-23
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR-Assisted Rehabilitation in Partial Supraspinatus Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned in a 1:1 ratio to either the virtual reality-assisted rehabilitation group or the conventional exercise group. Both groups received the same standard physiotherapy modalities, while the experimental group additionally performed VR-based exercises.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity measured by the Numeric Rating Scale (NRS)', 'timeFrame': 'Baseline and after 3 weeks of treatment', 'description': "Pain intensity was evaluated using an 11-point Numeric Rating Scale (NRS). Participants were asked to indicate the severity of their shoulder pain by selecting a number between 0 and 10, where 0 represented the absence of pain and 10 represented the most severe pain imaginable.Measurements were obtained both at rest and during shoulder movement, and the reported values were recorded as the participants' pain scores"}], 'secondaryOutcomes': [{'measure': 'Passive range of motion (ROM) of the affected shoulder', 'timeFrame': 'Baseline and after 3 weeks of treatment', 'description': 'shoulder ROM, including flexion, extension, abduction, internal rotation, and external rotation, was measured using a universal goniometer (Saehan Goniometer) within the tolerable range of motion'}, {'measure': 'Shoulder pain and functional impairment were assessed using the Shoulder Pain and Disability Index (SPADI)', 'timeFrame': 'Baseline and after 3 weeks of treatment', 'description': 'SPADI, a 13-item questionnaire consisting of pain (5 items) and disability (8 items) subscales. Each item is scored on a 0-10 scale, and total scores are expressed as percentages ranging from 0 to 100, with higher scores indicating greater pain and disability'}, {'measure': 'Health-related quality of life was evaluated using the Short Form-36 (SF-36) questionnaire', 'timeFrame': 'Baseline and after 3 weeks of treatment', 'description': 'SF-36 questionnaire, which includes 36 items across eight domains: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role emotional limitations, and mental health. Domain scores range from 0 to 100, with higher scores indicating better health status.'}, {'measure': 'Fear of movement and reinjury was assessed using the Tampa Scale of Kinesiophobia (TAMPA)', 'timeFrame': 'Baseline and after 3 weeks of treatment', 'description': 'TAMPA, a 17-item questionnaire scored on a four-point Likert scale. Total scores range from 17 to 68, with higher scores reflecting greater kinesiophobia'}, {'measure': 'The supraspinatus tendon thickness was measured using Ultrasonography(USG)', 'timeFrame': 'Baseline and after 3 weeks of treatment', 'description': 'The supraspinatus tendon thickness was measured using USG with the shoulder positioned in extension and external rotation, and the hand placed on the gluteal region. Tendon thickness was recorded according to the EURO-MUSCULUS standardized protocol. All ultrasonographic measurements were performed by the same experienced physician.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Kinesiophobia', 'Exercise Therapy', 'Rehabilitation', 'Rotator cuff'], 'conditions': ['Partial Supraspinatus Tear', 'Shoulder Pain']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to investigate the effects of virtual reality-assisted rehabilitation in patients with partial supraspinatus tendon tears. Virtual reality has emerged as a promising tool to enhance patient engagement and improve rehabilitation outcomes in musculoskeletal disorders; however, evidence in this patient population remains limited. Participants will be assigned to either a virtual reality-assisted rehabilitation group or a conventional rehabilitation group. Both groups will receive a structured physical therapy program, while the intervention group will additionally perform virtual reality-based exercises. The study will evaluate the potential benefits of virtual reality in improving clinical outcomes compared to conventional rehabilitation.', 'detailedDescription': 'This study aims to investigate the effects of virtual reality-assisted rehabilitation on pain, kinesiophobia, quality of life, and supraspinatus tendon thickness in patients with partial supraspinatus tendon tears.\n\nPartial supraspinatus tears are a common cause of shoulder pain and functional limitation, often leading to decreased quality of life and increased fear of movement. Virtual reality (VR) has emerged as an innovative rehabilitation tool that may enhance patient engagement and treatment adherence.\n\nThis study is designed as a randomized controlled trial to evaluate the effectiveness of virtual reality-assisted rehabilitation in patients with partial supraspinatus tendon tears.\n\nPartial supraspinatus tendon tears are a common cause of shoulder pain and functional impairment, often associated with reduced range of motion, decreased quality of life, and increased kinesiophobia. Conventional rehabilitation approaches are widely used; however, patient adherence and engagement may be limited.\n\nParticipants diagnosed with partial supraspinatus tendon tears will be randomly allocated to either a virtual reality-assisted rehabilitation group or a conventional rehabilitation group. Both groups will receive a standardized physical therapy program including hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation. In addition, participants in the virtual reality group will perform interactive, task-oriented exercises using virtual reality applications designed to enhance motivation and active participation. The control group will perform conventional therapeutic exercises targeting shoulder mobility, strength, and function.\n\nAll interventions will be applied over a structured treatment period under the supervision of a physiotherapist. Evaluations will be conducted at baseline and after completion of the intervention period.\n\nThis study aims to determine whether the integration of virtual reality into conventional rehabilitation provides additional clinical benefits in terms of pain reduction, functional improvement, and patient engagement in individuals with partial supraspinatus tendon tears.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Shoulder pain persisting for more than 4 weeks\n* Diagnosis of partial supraspinatus tendon tear confirmed by shoulder magnetic resonance imaging\n\nExclusion Criteria:\n\n* Received physiotherapy treatment within the previous 6 months\n* Received shoulder injection within the previous 6 months\n* History of tendon repair surgery\n* Presence of communication or cognitive impairment\n* Vertigo or vestibular disorders, or other conditions causing balance instability\n* History of epilepsy or seizures\n* Sensitivity to light\n* Diagnosed psychiatric disorders (including anxiety disorders or claustrophobia)\n* Any additional orthopedic condition affecting the same shoulder\n* Pregnancy or breastfeeding\n* Neurological, vascular, or cardiac disorders that may restrict functional capacity'}, 'identificationModule': {'nctId': 'NCT07478835', 'briefTitle': 'VR-Assisted Rehabilitation in Partial Supraspinatus Tears', 'organization': {'class': 'OTHER', 'fullName': 'Hitit University'}, 'officialTitle': 'Effects of Virtual Reality-Assisted Rehabilitation on Pain, Kinesiophobia, Quality of Life, and Supraspinatus Tendon Thickness in Patients With Partial Supraspinatus Tears: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2024-144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'virtual reality group', 'description': 'Participants in the experimental group received the same conventional treatment protocol and additionally performed virtual reality (VR)-assisted exercises. A Meta Quest Pro VR headset (Meta Platforms Inc.) was used to provide an immersive virtual environment during the intervention.', 'interventionNames': ['Behavioral: VR-assisted rehabilitation program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'participants performed a set of therapeutic exercises after the same conventional treatment protocol', 'interventionNames': ['Behavioral: Conventional shoulder exercise program']}], 'interventions': [{'name': 'VR-assisted rehabilitation program', 'type': 'BEHAVIORAL', 'description': 'Participants in the experimental group received the same conventional physiotherapy program as the control group and additionally performed virtual reality (VR)-assisted exercises. A Meta Quest Pro VR headset (Meta Platforms Inc.) was used to provide an immersive virtual environment during the intervention. The system provides high-resolution optics, a wide field of view, and six degrees of freedom (6DoF) motion tracking, allowing accurate tracking of upper extremity movements. VR-based exercises were designed to promote repetitive shoulder and upper limb movements through interactive, task-oriented activities within a three-dimensional virtual environment.', 'armGroupLabels': ['virtual reality group']}, {'name': 'Conventional shoulder exercise program', 'type': 'BEHAVIORAL', 'description': 'After completion of the standard physiotherapy modalities, participants performed a set of therapeutic exercises aimed at improving shoulder mobility and coordination of the shoulder girdle muscles', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19000', 'city': 'Çorum', 'country': 'Turkey (Türkiye)', 'facility': 'Hitit University Erol Olçok Research Hospital Physical Medicine and Rehabilitation Clinic', 'geoPoint': {'lat': 40.54889, 'lon': 34.95333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to institutional regulations and the absence of participant consent for public data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hitit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pınar Özge Başaran', 'investigatorAffiliation': 'Hitit University'}}}}