Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2026-01-01 @ 4:39 AM
Study NCT ID:
NCT07297706
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2025-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilates Exercises Versus Mirror Therapy on Shoulder Dysfunction Post Neck Dissection Surgeries
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D000088762', 'term': 'Mirror Movement Therapy'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of pain intensity', 'timeFrame': 'at baseline and after 8 weeks', 'description': 'Participants in both groups will mark a number on a 10-cm line (0 to 10) to indicate their pain level, with 10 being the most painful. Pain ratings during exercise was assessed at baseline (pre-treatment) and after 8 weeks of treatment (post-treatment) using visual analogue numeric pain scale'}], 'secondaryOutcomes': [{'measure': 'assessment of shoulder flexion range of motion', 'timeFrame': 'at baseline and after 8 weeks', 'description': "Shoulder range of motion (ROM) was assessed using a digital goniometer with participants seated. They will remove clothing from the affected shoulder and perform maximal active ROM during assessments. For shoulder flexion, the goniometer's axis will be placed over the acromion process, the stationary arm aligned with the midaxillary line, and the moving arm positioned along the central line of the upper arm."}, {'measure': 'Assessment of shoulder external rotation range of motion', 'timeFrame': 'at baseline and after 8 weeks', 'description': "Shoulder range of motion (ROM) was assessed using a digital goniometer with participants seated. They will remove clothing from the affected shoulder and perform maximal active ROM during assessments. External rotation is assessed when the upper limb is in a 90° abducted position. The goniometer's axis is positioned at the olecranon process, the stationary arm is aligned parallel to the ground, and the moving arm is adjusted to the ulna."}, {'measure': 'Assessment of the shoulder abduction range of motion', 'timeFrame': 'at baseline and after 8 weeks', 'description': "Shoulder range of motion (ROM) was assessed using a digital goniometer with participants seated. They will remove clothing from the affected shoulder and perform maximal active ROM during assessments. Shoulder abduction measurement involves positioning the goniometer's axis over the acromion process, aligning the stationary arm parallel to the spine, and setting the moving arm along the central line of the upper arm, following the protocol recommended by Lee and Kim"}, {'measure': 'assessment of upper limb function', 'timeFrame': 'at baseline and after 8 weeks', 'description': 'The study assessed upper limb function using the Arabic version of the Quick Disabilities of the Arm, Shoulder and Hand-9 scale before and after 8 weeks of treatment. The scale consists of 9 items rated on a 4-point Likert scale, where higher scores indicate increased disability and reduced function. A scaled score is computed from the total scores (0-100) using a specific formula, accommodating missing items by averaging remaining scores. Progress was measured by calculating the percent improvement in Quick Disabilities of the Arm, Shoulder and Hand-9 scores post-treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pilates Exercise', 'Mirror Therapy', 'Shoulder Pain', 'Dissection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the therapeutic effects of pilates exercises and mirror therapy on shoulder dysfunction post-neck dissection surgeries.', 'detailedDescription': 'Shoulder morbidity is a significant concern for patients undergoing neck dissection in head and neck cancer treatment, with more extensive surgeries correlated with higher postoperative shoulder issues. Preservation of the spinal accessory nerve during modified radical neck dissection reduces shoulder dysfunction. Shoulder pain often results from trapezius deficits due to nerve injury, leading to symptoms like shoulder droop and loss of function. Current management of oral and oropharyngeal carcinoma focuses on selective procedures that maintain nonlymphatic structures in the neck, as extended dissections are linked to increased shoulder dysfunction. This study aims to compare the effectiveness of pilates exercises and mirror therapy in improving shoulder dysfunction after neck dissection surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient's age ranged between 35-55 years.\n2. Both genders will participate in the study.\n3. All patients suffering from shoulder dysfunction post-unilateral neck dissection surgeries ( modified radical and selective neck dissection surgeries).\n4. All patients will have shoulder pain, limited ROM (flexion, abduction, external rotation) and limited shoulder function.\n5. All patients will begin the treatment program 1-3 months after neck dissection surgeries.\n6. All patients enrolled in the study will have their informed consent.\n\nExclusion Criteria:\n\n1. Subjects suffering from active malignant tumors.\n2. Subjects with rotator cuff tears or other shoulder ligaments injuries.\n3. A history of neck or ipsilateral shoulder injuries, pain in the last 6-month prior neck dissection surgeries.\n4. Adhesive capsulitis secondary to diabetes mellitus or fractures.\n5. Recurrent shoulder dislocation.\n6. Recent fractures or surgeries in the shoulder.\n7. Neurological disorder\n8. The presence of residual local regional cancer or distant metastases to other regions.\n9. Comorbid medical illness or psychiatric illness and visual disturbance that would prevent completion of treatment."}, 'identificationModule': {'nctId': 'NCT07297706', 'briefTitle': 'Pilates Exercises Versus Mirror Therapy on Shoulder Dysfunction Post Neck Dissection Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Pilates Exercises Versus Mirror Therapy on Shoulder Dysfunction Post Neck Dissection Surgeries', 'orgStudyIdInfo': {'id': 'Yasmen-Msc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilates exercises', 'description': 'This group will include 26 patients suffering from shoulder post-neck dissection surgeries (Modified radical and selective NDS). They will receive the pilate exercises for 40 min/session, 3 sessions/ week for 8 weeks, in addition to the traditional physical therapy program (ROM exercises, pendulum exercises, shoulder wheel exercises, stretching, and strengthening exercises for shoulder muscles)', 'interventionNames': ['Other: Pilates exercises', 'Other: Traditional physical therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mirror therapy', 'description': 'This group will include 26 patients suffering from shoulder dysfunction post neck dissection surgeries (modified radical, and selective NDS), they will receive Mirror therapy for 40 min/session, 3 sessions/ week for 8 weeks in addition to the traditional physical therapy program (ROM exercises, pendulum exercises, shoulder wheel exercises, stretching, and strengthening exercises for shoulder muscles)', 'interventionNames': ['Other: Mirror therapy', 'Other: Traditional physical therapy']}], 'interventions': [{'name': 'Pilates exercises', 'type': 'OTHER', 'description': 'Pilates exercise aids in recovery post-breast cancer surgery by improving daily living activities, shoulder function, and quality of life. It emphasizes principles such as centralization, concentration, control, precision, flow, and breathing, enhancing muscle strength and flexibility. Additionally, mild stretching exercises contribute to maintaining and increasing range of motion, and Pilates can be tailored to individual patient needs and abilities.', 'armGroupLabels': ['Pilates exercises']}, {'name': 'Mirror therapy', 'type': 'OTHER', 'description': 'Mirror therapy has been shown to enhance shoulder function in patients with shoulder problems immediately after the intervention. Three-minute of Mirror therapy improved forward flexion by 14.5° in patients with shoulder pain and limited shoulder range of motion', 'armGroupLabels': ['Mirror therapy']}, {'name': 'Traditional physical therapy', 'type': 'OTHER', 'description': 'including (ROM exercises, pendulum exercises, shoulder wheel exercises, stretching, and strengthening exercises for shoulder muscles)', 'armGroupLabels': ['Mirror therapy', 'Pilates exercises']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr El Ainy Learning Hospital and National Cancer Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Yasmen gamal Elrakhawi', 'investigatorAffiliation': 'Cairo University'}}}}