Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05955820
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2023-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Suspension System on Impingement Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-13', 'studyFirstSubmitDate': '2023-07-08', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in active shoulder ROM', 'timeFrame': 'Baseline', 'description': "Proprioception will be tested by using inclinometer to determine patient's active shoulder range of motion for internal and external rotation, flexion, and extension"}, {'measure': 'Improvement in functional performance', 'timeFrame': 'Baseline', 'description': 'Assessment of function using SPADI subscale which contains 13 items that assess two domains; a 5-item subscale that measures pain and 8-item subscale that measures disability. In addition, Several non-specific strength/power tests may assist in determining the level of functional performance of the patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Impingement Syndrome']}, 'referencesModule': {'references': [{'pmid': '27727288', 'type': 'BACKGROUND', 'citation': 'Chen L, Chen J, Peng Q, Chen J, Zou Y, Liu G. Effect of Sling Exercise Training on Balance in Patients with Stroke: A Meta-Analysis. PLoS One. 2016 Oct 11;11(10):e0163351. doi: 10.1371/journal.pone.0163351. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the effect of shoulder exercise using a selected suspension system exercise program on pain, disability, functional performance and proprioception in patients with subacromial impingement syndrome.', 'detailedDescription': 'Two groups were assigned to this study, the first one received four conventional exercises that designed for shoulder impingement syndrome, the second group received the same four conventional exercises plus four selected suspension system exercises.\n\nThe sessions were conducted three times per week fir four weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Fifty-eight subjects with SIS (more than three months).\n2. Their age ranges from 20-45 years old\n3. Level of pain (at least 2/10 on VAS)\n4. Body mass index (BMI) between 18-25\n5. Subjects must show positive results in at least two of the following tests: Neer's impingement test, Hawkins-Kennedy test, supraspinatus (empty can) test, apprehension and relocation test.\n\nExclusion Criteria:\n\nThe subjects will be excluded if they had:\n\n1. Received physiotherapy at last 3 months.\n2. Received corticosteroids injection in subacromial space at last 3 months.\n3. Received anti-inflammatory medications.\n4. Have a fracture or dislocation in shoulder, neck and thoracic regions.\n5. Have an acute rotator cuff tear.\n6. Have tumor or malignancy in shoulder region.\n7. Have neurologic problems in shoulder, neck and thoracic regions.\n8. Have cooperation difficulties due to cognitive disorders."}, 'identificationModule': {'nctId': 'NCT05955820', 'briefTitle': 'Suspension System on Impingement Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of a Selected Suspension System Exercise Program on Patients With Subacromial Impingement Syndrome', 'orgStudyIdInfo': {'id': 'Impingement syndrome new EX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional exercises for impingement syndrome', 'description': 'Four exercises (prone extension, side-lying external rotation, side-lying forward flexion, prone horizontal abduction with external rotation) will be performed for three sets of 10 repetitions', 'interventionNames': ['Device: Dumbbells']}, {'type': 'EXPERIMENTAL', 'label': 'Suspension system exercises for impingement syndrome', 'description': 'Four exercises (Kneeling shoulder extension, Supine/ standing / kneeling row, sitting press up, kneeling push up) will be performed for 3-6 sets of 10 repetitions', 'interventionNames': ['Device: Suspension system']}], 'interventions': [{'name': 'Suspension system', 'type': 'DEVICE', 'otherNames': ['Neurac system'], 'description': 'Participants will be tested by four exercises designed for impingement syndrome using the suspension system', 'armGroupLabels': ['Suspension system exercises for impingement syndrome']}, {'name': 'Dumbbells', 'type': 'DEVICE', 'description': 'Participants will be tested by four exercises designed for impingement syndrome using Dumbbells', 'armGroupLabels': ['Conventional exercises for impingement syndrome']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo university faculty of physical therapy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROF.DR.Enass Fawzy Youssif', 'investigatorFullName': 'Omnia Mumdouh Yousef', 'investigatorAffiliation': 'Cairo University'}}}}