Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT07205094
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2025-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Telerehabilitation on Quality of Life, Pain, and Function After Rotator Cuff Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-24', 'size': 203865, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-10-01T11:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were assigned to two groups: a telerehabilitation group (n=20) and a conventional physiotherapy control group (n=10). Both groups followed an eight-week exercise program, including range of motion, stretching, strengthening, and stabilization exercises. Outcomes such as pain, shoulder mobility, muscle strength, functional ability, and quality of life were compared between the groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-10-01', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity (Visual Analog Scale [VAS], 0-10 points)', 'timeFrame': 'Baseline and after 8-week intervention', 'description': 'Pain intensity was assessed before and after the 8-week intervention using the Visual Analog Scale (VAS) during activity, at rest, and at night. Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating worse pain. Changes were compared between the telerehabilitation group and the conventional physiotherapy control group.'}], 'secondaryOutcomes': [{'measure': 'Shoulder range of motion (Goniometer, degrees)', 'timeFrame': 'Baseline and after 8-week intervention', 'description': 'Shoulder flexion, extension, abduction, adduction, internal rotation, and external rotation were measured using a goniometer before and after the 8-week intervention. Normal ranges for adults are: flexion 0-180°, extension 0-45°, abduction 0-180°, adduction 0-45°, internal rotation 0-70°, external rotation 0-90°. Changes were compared between the telerehabilitation group and control group.'}, {'measure': 'Muscle strength (Manual Muscle Testing, 0-5 scale)', 'timeFrame': 'Baseline and after 8-week intervention', 'description': 'Muscle strength of shoulder flexors, extensors, abductors, adductors, internal and external rotators was assessed using manual muscle testing before and after the 8-week intervention. Scores range from 0 (no contraction) to 5 (normal strength), with higher scores indicating stronger muscles. Changes were compared between groups.'}, {'measure': 'Quality of life (Western Ontario Rotator Cuff Index [WORC], 0-2100 points)', 'timeFrame': 'Baseline and after 8-week intervention', 'description': 'Quality of life was assessed before and after the 8-week intervention using the WORC questionnaire. Scores range from 0 (best quality of life) to 2100 (worst quality of life), with lower scores indicating better quality of life. Changes were compared between the telerehabilitation group and control group.'}, {'measure': 'Functional status (Disabilities of the Arm, Shoulder, and Hand [DASH] questionnaire, 0-100 points)', 'timeFrame': 'Baseline and after 8-week intervention.', 'description': 'Functional status was measured before and after the 8-week intervention using the DASH questionnaire. Scores for each subscale (function, symptoms, social/role function) were calculated separately. Scores range from 0 (no disability) to 100 (maximum disability), with higher scores indicating worse functional status. Changes were compared between the telerehabilitation group and control group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rotator Cuff Surgery', 'Telerehabilitation Method', 'Pain', 'Quality of Life', 'Function'], 'conditions': ['Rotator Cuff Tears']}, 'descriptionModule': {'briefSummary': 'he purpose of this study was to find out whether telerehabilitation after rotator cuff surgery can help reduce pain, improve shoulder movement, increase muscle strength, enhance functional ability, and improve quality of life compared to conventional physiotherapy. The study included 30 participants who had undergone rotator cuff surgery at least six weeks earlier. They were divided into two groups: a telerehabilitation group (n=20) and a conventional physiotherapy control group (n=10). Both groups followed an eight-week exercise program, which included range of motion, stretching, strengthening, and stabilization exercises.\n\nThe study found that both groups improved in pain, shoulder mobility, muscle strength, function, and quality of life. Participants in the telerehabilitation group showed particularly greater improvements in shoulder flexion, flexor muscles, external rotator muscles, and overall quality of life. These results suggest that telerehabilitation may be an effective alternative to traditional physiotherapy after rotator cuff surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who have undergone rotator cuff surgery\n* At least 6 weeks post-surgery\n* Possess the necessary technology for telerehabilitation (smartphone, computer, internet access)\n* Willing to participate in the study and have signed the informed consent form\n\nExclusion Criteria:\n\n* History of neurological disorders\n* Severe cardiovascular or pulmonary conditions\n* Need for special medical care due to postoperative infection or complications\n* Inability to comply with telerehabilitation due to psychiatric conditions\n* Lack of access to or knowledge of technology required for telerehabilitation\n* Participation in another rehabilitation program during the study period'}, 'identificationModule': {'nctId': 'NCT07205094', 'acronym': 'TELERO-ROT', 'briefTitle': 'Effect of Telerehabilitation on Quality of Life, Pain, and Function After Rotator Cuff Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Bahçeşehir University'}, 'officialTitle': 'Effect of Telerehabilitation Versus Conventional Physiotherapy on Quality of Life, Pain, and Functional Outcomes in Patients Following Rotator Cuff Surgery', 'orgStudyIdInfo': {'id': 'AYSAN2025-RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation', 'description': '8-week telerehabilitation program including range of motion, stretching, strengthening, and stabilization exercises', 'interventionNames': ['Other: Telerehabilitation exercise program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Physiotherapy', 'description': '8-week conventional face-to-face physiotherapy program including range of motion, stretching, strengthening, and stabilization exercises', 'interventionNames': ['Other: Conventional physiotherapy program']}], 'interventions': [{'name': 'Telerehabilitation exercise program', 'type': 'OTHER', 'description': '8-week telerehabilitation program including range of motion, stretching, strengthening, and stabilization exercise', 'armGroupLabels': ['Telerehabilitation']}, {'name': 'Conventional physiotherapy program', 'type': 'OTHER', 'description': '8-week conventional face-to-face physiotherapy program including range of motion, stretching, strengthening, and stabilization exercises', 'armGroupLabels': ['Conventional Physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Beykent University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aysan Yaghoubi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Master's Graduate in Physiotherapy and Rehabilitation", 'investigatorFullName': 'Aysan Yaghoubi', 'investigatorAffiliation': 'Bahçeşehir University'}}}}