Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-02 @ 8:44 AM
Study NCT ID:
NCT05088668
Status:
SUSPENDED
Last Update Posted:
2022-11-22
First Post:
2021-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Augmented Reality for Shoulder Pain and Scapular Dyskinesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The researchers involved in measuring outcomes will not be aware of treatment allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'whyStopped': 'Logistic issues', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-17', 'studyFirstSubmitDate': '2021-09-19', 'studyFirstSubmitQcDate': '2021-10-09', 'lastUpdatePostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain intensity', 'timeFrame': 'Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months', 'description': 'Pain intensity measured with a visual analogue scale which ranges from 0 (no pain) to 10 (worst imaginable pain).'}], 'secondaryOutcomes': [{'measure': 'Change in shoulder disability', 'timeFrame': 'Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months', 'description': 'Shoulder disability measured with Shoulder Pain and Disability Index (SPADI), which ranges from 0 (no disability) to 100 (maximum degree of disability).'}, {'measure': 'Change in arm disability', 'timeFrame': 'Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months', 'description': 'Arm disability measured with Disabilities of the Arm, Shoulder, and Hand (Quick-DASH), which ranges from 0 (no disability) to 100 (maximum degree of disability).'}, {'measure': 'Change in kinesiophobia', 'timeFrame': 'Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months', 'description': 'Kinesiophobia measured with Tampa Scale of Kinesiophobia (TSK-11), which ranges from 0 (no kinesiophobia) to 100 (maximum degree of kinesiophobia)'}, {'measure': 'Change in catastrophism', 'timeFrame': 'Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months', 'description': 'Pain catastrophism measured with Pain Catastrophism Scale (PCS), which ranges from 0 (no catastrophism) to 100 (severe catastrophism).'}, {'measure': 'Change in shoulder range of motion', 'timeFrame': 'Baseline, 1-month, 2-months, 3-months, and 6-months', 'description': 'Shoulder range of motion in abduction, flexion, internal and external rotation, measured with a goniometer'}, {'measure': 'Change in surface electromiography', 'timeFrame': 'Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months', 'description': 'Electromiographic activity of serratus anterior, upper trapezius, lower trapezius, and deltoid medimum muscles. Percent of electromiographic activity as a function of maximum voluntary isometric contraction, as well as latency of muscle activation during scaption will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Pain']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to analyze whether an Augmented Reality based scapular stabilization exercise program is more effective than conventional programs in patients with chronic shoulder pain and Scapular Dyskinesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral mechanical shoulder pain of nonspecific origin (non-traumatic) lasting at least 3 months.\n* Weakness in flexion, abduction and/or external rotation isometric strength testing.\n* Presence of scapular dyskinesis according to Kibler, Scapular Assistance Test, and Scapular Reposition Test.\n\nExclusion Criteria:\n\n* Previous shoulder surgery.\n* History of shoulder fracture or glenohumeral luxation.\n* History of acromioclavicular joint injury.\n* Presence of massive rotator cuff rears.\n* Presence of frozen shoulder.\n* Cervical hernias or radiculopathy.\n* Fibromyalgia.\n* Neuropathic pain.\n* Cervical and/or vestibular problems with dizziness, unsteadiness, or vertigo.\n* Medical contraindication for performing exercise (cardio-vascular or cardio-pulmonar diseases, systemic diseases, metabolic diseases in non-controlled acute state).\n* Blindness.\n* Actually being treated with physical therapy for shoulder pain.'}, 'identificationModule': {'nctId': 'NCT05088668', 'briefTitle': 'Augmented Reality for Shoulder Pain and Scapular Dyskinesis', 'organization': {'class': 'OTHER', 'fullName': 'University of Alcala'}, 'officialTitle': 'The Effectiveness of Augmented Reality Combined With Scapular Repositioning Exercises in Patients With Chronic Shoulder Pain and Scapular Dyskinesis: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '25072021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Agumented Reality combined with scapular exercises', 'description': 'Scapular exercises performed with glasses of augmented reality during sessions at clinic, and without glasses at home.', 'interventionNames': ['Other: Augmented reality', 'Other: Scapular repositioning exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Scapular exercises', 'description': 'Scapular exercises performed all the time without glasses.', 'interventionNames': ['Other: Scapular repositioning exercise']}], 'interventions': [{'name': 'Augmented reality', 'type': 'OTHER', 'description': 'The subjects will perform scapular repositioning exercise using glasses of augmented reality to see their scapular movement simultaneously. Furthermore, they will also see at the same time a video record of an "ideal" scapular movement, and will me encouraged to simulate that "ideal" scapular movement.', 'armGroupLabels': ['Agumented Reality combined with scapular exercises']}, {'name': 'Scapular repositioning exercise', 'type': 'OTHER', 'description': 'Subjects will perform scapular repositioning exercises for improving scapular movement.', 'armGroupLabels': ['Agumented Reality combined with scapular exercises', 'Scapular exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28805', 'city': 'Alcalá de Henares', 'country': 'Spain', 'facility': 'Ruben Fernandez-Matias', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruben Fernandez Matias', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Ruben Fernandez Matias', 'investigatorAffiliation': 'University of Alcala'}}}}