Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT05961033
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2023-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Virtual Reality Based Exercises in Patients With Adhesive Capsulitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2023-07-17', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain severity change', 'timeFrame': 'Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises', 'description': 'pain intensity after VR based exercises will be assessed by Visual Analogue Scale (VAS). VAS is often used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain (0-10). Ten shows more pain intensity.'}, {'measure': 'Quality of Life level change', 'timeFrame': 'Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises', 'description': 'Level of Quality of Life will be assessed by Short Form- 36 (SF-36). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used. High points show high quality ol life levels.'}, {'measure': 'Shoulder functionality level change', 'timeFrame': 'Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises', 'description': "Shoulder functionality will be assessed by Shoulder and Pain Disability Inventory (SPADI). The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst)."}], 'secondaryOutcomes': [{'measure': 'Shoulder mobility angles change', 'timeFrame': 'Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises', 'description': 'Shouder mobility will be assessed by goniometric measurement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Quality of Life', 'Range of Motion', 'Virtual Reality']}, 'descriptionModule': {'briefSummary': 'Musculoskeletal disorders such as adhesive capsulitis (AC) affect tissues such as muscles, bones, joints, tendons and ligaments and are the second most disabling condition worldwide. Musculoskeletal Systemic disorders are typically characterized by pain, limitations in joint range of motion or functional ability.\n\nExisting studies have shown that Virtual Reality (VR) is beneficial in pain management for example; pain relief during dressing changes in burn patients. VR can also reduce anxiety, distract from the fear of pain, and reduce stress. It can distract the patients who are afraid of moving due to pain and enable them to move freely. In this study, AC patients will be treated with VR application. Patients pain levels, upper extremity range of motion, functional activity levels and quality of life levels will be evaluated. A total of 36 patients will be included in the study.\n\nThis observational randomized controlled study will contribute to the literature by investigating the effects of VR based exercises in individuals with AC.', 'detailedDescription': 'Individuals in the first group to be included in the study group will be included in a VR-based exercise program for half an hour a day, 5 days a week for a total of 4 weeks, in addition to routine electrotherapy programs for half an hour a day, 5 days a week for a total of 4 weeks. These individuals will use the Oculus Quest 2 VR system in the virtual environment thanks to the three-dimensional glasses and handpiece that can be worn on the head. They will play the registered games. These games will include purpose-oriented activities such as lying on the head and using bilaterally, which are intended to use the upper extremities of individuals with AC in daily life. Participants will be treated under the constant supervision of a physiotherapist, will be rested at the end of the exercise, and will leave the clinic after making sure that there is no problem.\n\nIndividuals in the second group, who will be included in the traditional exercise group, will be included in the stretching and strengthening exercise program for half an hour a day, 5 days a week for a total of 4 weeks, for a total of 10 hours, in addition to the routine electrotherapy programs for half an hour a day, 5 days a week for a total of 4 weeks. The exercises will be performed by a physiotherapist working in the clinic and blind to the study.\n\nPain levels (Visual Analogue Scale), upper extremity range of motion (Goniometric measurement), functional activity levels (Shoulder Pain and Disability Index) and quality of life (SF-36) of all participants will be evaluated before and after the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosed as having Adhesive Capsulitis and being treated in the rehabilitation center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 18-65\n* Clinical diagnosis of adhesive capsulitis\n\nExclusion Criteria:\n\n* Inability to cooperate VR\n* Surgery on the upper extremity or trunk\n* Neurological disease'}, 'identificationModule': {'nctId': 'NCT05961033', 'briefTitle': 'The Effects of Virtual Reality Based Exercises in Patients With Adhesive Capsulitis', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'The Effects of Virtual Reality Based Exercises on Pain, Range of Motion and Quality of Life in Patients With Adhesive Capsulitis', 'orgStudyIdInfo': {'id': '32/22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study', 'description': 'Individuals in the first group to be included in the study group will be included in a virtual reality-based exercise program for half an hour a day, 5 days a week for a total of 4 weeks, in addition to routine electrotherapy programs for half an hour a day, 5 days a week for a total of 4 weeks. These individuals will be able to play the games saved in the Oculus Quest 2 SG system in the virtual environment, thanks to the three-dimensional glasses and handpiece that can be worn on the head.', 'interventionNames': ['Device: Virtual Reality based exercises']}, {'label': 'control', 'description': 'Individuals who receive traditional electrotherapy and exercise program'}], 'interventions': [{'name': 'Virtual Reality based exercises', 'type': 'DEVICE', 'description': 'Play VR games', 'armGroupLabels': ['study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University Faculty of Medicine Hospital', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}, {'city': 'Sakarya', 'country': 'Turkey (Türkiye)', 'facility': 'Sakarya University Physiotherapy and Rehabilitation Research Center', 'geoPoint': {'lat': 39.50333, 'lon': 32.07583}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sakarya University of Applied Sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Oguzhan Bahadir DEMIR', 'investigatorAffiliation': 'Kocaeli University'}}}}