Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:09 AM
Study NCT ID:
NCT07482735
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Perturbation Exercise Protocol in Patients With Partial Rotator Cuff Tear: A Single-Blind Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Paralel Randomized'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-15', 'studyFirstSubmitDate': '2026-03-15', 'studyFirstSubmitQcDate': '2026-03-15', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder muscle strength', 'timeFrame': 'Baseline, Day 10 (post-treatment), 1 month follow-up', 'description': 'Shoulder flexor, abductor, and medial and lateral rotator muscles muscle strength measured by Handheld Dynamometer'}], 'secondaryOutcomes': [{'measure': 'Shoulder Range of Motion', 'timeFrame': 'Time Frame: Baseline, Day 10 (post-treatment), 1 month follow-up', 'description': 'Measuremets for shoulder range of motion (flexion, abduction, and internal and external rotation) with a üniversal goniometer'}, {'measure': 'Shoulder Pain', 'timeFrame': 'Baseline, Day 10 (post-treatment), 1 month follow-up', 'description': 'Measumets for shoulder pain with VAS'}, {'measure': 'Proprioception', 'timeFrame': 'Baseline, Day 10 (post-treatment), 1 month follow-up', 'description': 'The target angle was 90 degrees of shoulder flexion. Joint repositioning errors for this angle were determined using a universal goniometer.'}, {'measure': 'Functional Status', 'timeFrame': 'Baseline, Day 10 (post-treatment), 1 month follow-up', 'description': 'Functional status of the shoulder was determined using the Constant-Murley Score (CMS). The total CMS score is 100, comprising 15 for pain, 20 for activities of daily living, 40 for range of motion, and 25 for muscle strength. An increased CMS score indicates better function.'}, {'measure': 'Dynamic balance', 'timeFrame': 'Baseline, Day 10 (post-treatment), 1 month follow-up', 'description': 'The Upper Quadrant Y Balance Test was used to measure the dynamic balance of the upper extremity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Partial rotator cuff tears', 'Perturbation-based rehabilitation', 'Proprioception', 'Muscle strength', 'Functional performance'], 'conditions': ['Partial Rotator Cuff Tears']}, 'descriptionModule': {'briefSummary': 'Partial rotator cuff tears negatively affect shoulder stability, proprioception, and neuromuscular control. Perturbation-based rehabilitation has been shown to enhance reflex muscle activation and dynamic joint stabilization; however, randomized controlled studies investigating its effects in patients with partial rotator cuff tears are limited.\n\nThis single-blind randomized controlled trial aims to investigate the long-term effects of a perturbation exercise protocol on pain, proprioception, muscle strength, range of motion, and functional performance in individuals with partial rotator cuff tears.\n\nSixty participants will be randomly assigned to either a conventional physiotherapy group or a perturbation-based rehabilitation group. Outcomes will be assessed at baseline, post-treatment (10 days), and one month follow-up.', 'detailedDescription': 'Partial rotator cuff tears are common musculoskeletal disorders that negatively affect shoulder stability, neuromuscular control, muscle strength, and functional performance. Damage to mechanoreceptors within the rotator cuff complex may impair proprioceptive feedback and dynamic stabilization, leading to persistent pain and recurrent microtrauma.\n\nConventional physiotherapy programs primarily focus on pain reduction and strengthening exercises. However, neuromuscular control deficits and proprioceptive impairments may not be fully addressed through traditional rehabilitation approaches. Perturbation-based exercise training has been proposed as a rehabilitation strategy aimed at enhancing reflexive muscle activation, improving co-contraction patterns, and promoting dynamic joint stability through controlled external disturbances.\n\nAlthough perturbation exercises have shown promising effects in other shoulder pathologies and postoperative populations, randomized controlled trials investigating their long-term effects in individuals with partial rotator cuff tears are limited.\n\nThis single-blind randomized controlled trial aims to evaluate the effectiveness of a perturbation-based rehabilitation program in addition to conventional physiotherapy on shoulder muscle strength (primary outcome), pain intensity, range of motion, proprioception, and functional performance. Sixty participants will be randomly assigned to either a control group receiving conventional therapy alone or an experimental group receiving additional perturbation exercises. Outcomes will be assessed at baseline, post-treatment (10 days), and one-month follow-up.\n\nThe findings of this study may contribute to evidence-based rehabilitation strategies and help optimize treatment protocols for patients with partial rotator cuff tears.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years\n* Clinically diagnosed partial rotator cuff tear\n* Suitable for physiotherapy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Full-thickness rotator cuff tear\n* Previous shoulder surgery\n* History of fracture or dislocation\n* Adhesive capsulitis\n* Neurological deficit in upper extremity\n* Professional athletes\n* Active systemic rheumatologic disease'}, 'identificationModule': {'nctId': 'NCT07482735', 'briefTitle': 'Effect of Perturbation Exercise Protocol in Patients With Partial Rotator Cuff Tear: A Single-Blind Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cumhuriyet University'}, 'officialTitle': 'Effects of Perturbation-Based Rehabilitation on Pain, Proprioception, Muscle Strength, Range of Motion and Functional Performance in Patients With Partial Rotator Cuff Tear: A Single-Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SCU-FTR-SB-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Conventional physiotherapy + perturbation exercise protocol', 'interventionNames': ['Other: Conventional physiotherapy', 'Other: Perturbation exercise protocol']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Conventional physiotherapy only', 'interventionNames': ['Other: Conventional physiotherapy']}], 'interventions': [{'name': 'Conventional physiotherapy', 'type': 'OTHER', 'otherNames': ['Non'], 'description': 'Non', 'armGroupLabels': ['Control Group', 'Experimental Group']}, {'name': 'Perturbation exercise protocol', 'type': 'OTHER', 'description': 'Non', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58140', 'city': 'Sivas', 'country': 'Turkey (Türkiye)', 'facility': 'Sivas Cumhuriyet University', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}], 'overallOfficials': [{'name': 'Selvin Balki, Assoc. prof. Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Cumhuriyet University'}, {'name': 'Ayşe Nur Engindoğan, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cumhuriyet University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumhuriyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, Ph.D.', 'investigatorFullName': 'Selvin BALKİ', 'investigatorAffiliation': 'Cumhuriyet University'}}}}