Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-03-05 @ 12:18 AM
Study NCT ID:
NCT06599567
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2024-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Graded Motor Imagery and Biofeedback in Rotator Cuff Injury
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients will not know which group they belong to and the physiotherapist who makes the evaluations will not know which treatment the patients receive. Our study will be conducted in a double-blind manner.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. st group traditional therapy\n2. nd group : traditional therapy and graded motor imagery\n3. rd group traditional therapy and biofeedback training with nintendo wii'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quickDASH short form', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'QuickDASH will be used to assess upper extremity functional limitations and symptoms in patients with rotator cuff injuries Scoring: QuickDASH consists of 11 questions, each rated on a scale from 1 to 5. The final score is calculated between 0 (no difficulty) and 100 (extreme difficulty)'}], 'secondaryOutcomes': [{'measure': 'Shoulder Pain', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'NPRS (Numeric Pain Rating Scale) is a self-reported scale used to assess the intensity of pain. If you are conducting research on shoulder and arm injuries, such as rotator cuff pathologies, you can use this scale to evaluate the patients\\' pain levels.\n\nNPRS is an 11-point scale where the patient rates their pain from 0 (no pain) to 10 (worst possible pain)'}, {'measure': 'Range of motion', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'ROM (Range of Motion) is an objective measurement used to assess the mobility and flexibility of joints. If you are conducting research on shoulder injuries such as rotator cuff pathologies, you can use ROM assessments to evaluate improvements in joint mobility.\n\nROM is usually measured in degrees using a goniometer. Specific movements like shoulder flexion, extension, abduction, and rotation are assessed.'}, {'measure': 'Kinesiophobia', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': "The Tampa Scale of Kinesiophobia (TSK) is a self-reported questionnaire used to assess the fear of movement or re-injury in patients. If you are conducting research on shoulder injuries such as rotator cuff pathologies, you can use this scale to evaluate patients' fear of movement and its impact on recovery.\n\nThe TSK consists of 17 items, each rated on a 4-point Likert scale. The total score ranges from 17 to 68, with higher scores indicating greater fear of movement."}, {'measure': 'Global Rating of Change', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'The Global Rating of Change (GRC) is a self-reported scale used to measure a patient\\'s perception of overall improvement or deterioration over time. If you are conducting research on rotator cuff injuries, you can use the GRC to evaluate patients\\' subjective assessment of their progress.\n\nThe GRC is typically measured on a scale ranging from -5 (a very great deal worse) to +5 (a very great deal better), with 0 indicating no change.'}, {'measure': 'Lateralization', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'The Recognise app is a tool used to assess lateralization, which involves identifying left and right body parts to measure motor imagery and cortical representation. If you are conducting research on rotator cuff injuries, you can use this app to evaluate patients\\' ability to recognize and distinguish between left and right body parts, which can be important in assessing changes in cortical representation and motor imagery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['graded motor imagery', 'pain', 'shoulder joint', 'rehabilitation', 'rotator cuff injuries'], 'conditions': ['Rotator Cuff Injuries', 'Rotator Cuff Injury', 'Rotator Cuff Syndrome']}, 'referencesModule': {'availIpds': [{'id': 'sample size', 'url': 'https://bmjopen.bmj.com/content/10/11/e039976', 'type': 'Individual Participant Data Set', 'comment': 'reference article to see sample size with g power'}, {'id': 'Nintendo Wii protocol', 'url': 'https://pubmed.ncbi.nlm.nih.gov/28330586/', 'type': 'Study Protocol'}, {'id': 'Graded motor imagery protocol', 'url': 'https://pubmed.ncbi.nlm.nih.gov/32003812/', 'type': 'Study Protocol'}], 'references': [{'pmid': '32031724', 'type': 'BACKGROUND', 'citation': 'Suso-Marti L, La Touche R, Angulo-Diaz-Parreno S, Cuenca-Martinez F. Effectiveness of motor imagery and action observation training on musculoskeletal pain intensity: A systematic review and meta-analysis. Eur J Pain. 2020 May;24(5):886-901. doi: 10.1002/ejp.1540. Epub 2020 Feb 20.'}, {'pmid': '24575717', 'type': 'BACKGROUND', 'citation': 'Hoyek N, Di Rienzo F, Collet C, Hoyek F, Guillot A. The therapeutic role of motor imagery on the functional rehabilitation of a stage II shoulder impingement syndrome. Disabil Rehabil. 2014;36(13):1113-9. doi: 10.3109/09638288.2013.833309. Epub 2014 Feb 28.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/24575717/', 'label': 'The therapeutic role of motor imagery on the functional rehabilitation of a stage II shoulder impingement syndrome'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/32031724/', 'label': 'Effectiveness of motor imagery and action observation training on musculoskeletal pain intensity: A systematic review and meta-analysis'}]}, 'descriptionModule': {'briefSummary': 'Purpose: This study aims to compare the effectiveness of conventional therapy, Graded Motor Imagery (GMI), and Nintendo Wii-based biofeedback therapy in patients with rotator cuff injuries. The goal is to evaluate the impact of these three methods on pain management, range of motion (ROM), patient satisfaction, and functional performance.\n\nHypotheses:\n\nThere is no significant difference in pain management between conventional therapy, GMI, and Wii-based biofeedback therapy.\n\nThere is no significant difference in shoulder ROM between the three therapies. There is no significant difference in patient satisfaction among the therapies. There is no significant difference in functional performance improvement between the therapies.\n\nMethods: A randomized, double-blind, controlled trial will be conducted with 36 patients with rotator cuff injuries. They will be randomly assigned to one of three groups and undergo 6 weeks of treatment. Pain, ROM, and functional performance will be assessed pre- and post-treatment. Data will be analyzed using ANOVA.\n\nPotential Outcomes/Significance: The study may show that innovative approaches like GMI and Wii-based biofeedback therapy are effective treatment options. Results could contribute to developing new strategies for treating chronic pain and motor dysfunctions.', 'detailedDescription': 'Study Title: Comparative Effectiveness of Conventional Therapy, Graded Motor Imagery (GMI), and Nintendo Wii-Based Biofeedback Therapy in Rotator Cuff Injuries\n\nPurpose: The primary aim of this study is to compare the effectiveness of three different therapeutic interventions-conventional therapy, Graded Motor Imagery (GMI), and Nintendo Wii-based biofeedback therapy-in managing rotator cuff injuries. The study will evaluate the impact of these therapies on key outcomes including pain management, shoulder range of motion (ROM), patient satisfaction, and functional performance. By comparing these methods, the study seeks to determine which therapy offers the best overall benefit for patients with rotator cuff injuries.\n\nHypotheses:\n\nHypothesis 1: There is no significant difference in pain management between conventional therapy, GMI, and Wii-based biofeedback therapy.\n\nAlternative Hypothesis (H1): Significant differences in pain management exist among these therapies.\n\nHypothesis 2: There is no significant difference in shoulder ROM between conventional therapy, GMI, and Wii-based biofeedback therapy.\n\nAlternative Hypothesis (H1): Significant differences in shoulder ROM exist among these therapies.\n\nHypothesis 3: There is no significant difference in patient satisfaction among conventional therapy, GMI, and Wii-based biofeedback therapy.\n\nAlternative Hypothesis (H1): Significant differences in patient satisfaction exist among these therapies.\n\nHypothesis 4: There is no significant difference in functional performance improvement between conventional therapy, GMI, and Wii-based biofeedback therapy.\n\nAlternative Hypothesis (H1): Significant differences in functional performance improvement exist among these therapies.\n\nMethods: This study will use a randomized, double-blind, controlled trial design. A total of 36 patients diagnosed with rotator cuff injuries will be randomly assigned to one of three treatment groups: conventional therapy, Graded Motor Imagery (GMI), or Nintendo Wii-based biofeedback therapy. Each group will undergo their respective treatment for a duration of 6 weeks. The effectiveness of each treatment will be assessed through measurements taken before and after the intervention. Pain levels, shoulder ROM, and functional performance will be evaluated using standardized assessment tools. Statistical analysis will be performed using ANOVA to compare outcomes across the three treatment groups.\n\nPotential Outcomes/Significance: The results of this study have the potential to highlight the effectiveness of innovative therapies like GMI and Wii-based biofeedback therapy in the treatment of rotator cuff injuries. If these methods are found to be more effective than conventional therapy, they could represent valuable additions to treatment options for patients suffering from chronic pain and motor dysfunctions. The findings may contribute to the development of new, evidence-based strategies for managing rotator cuff injuries and improving patient outcomes in rehabilitation settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18-65\n* A rotator cuff injury was diagnosed and conservative treatment was decided\n* Volunteer for research\n* People who can read, write and understand Turkish\n\nExclusion Criteria:\n\n* Having neurological findings of cervical origin\n* An additional different orthopedic problem in the same shoulder (Full thickness rotator cuff tear, adhesive capsulitis and glenohumeral instability)\n* Uncooperative or mental problem\n* Neurological, vascular and cardiac problem that limits function'}, 'identificationModule': {'nctId': 'NCT06599567', 'briefTitle': 'Graded Motor Imagery and Biofeedback in Rotator Cuff Injury', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'THE EFFECT OF GRADED MOTOR IMAGERY AND NINTENDO WII-BASED BIOFEEDBACK TECHNIQUES ON ROTATOR CUFF PATHOLOGIES', 'orgStudyIdInfo': {'id': '8Z3KqXp1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional therapy', 'description': 'Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises', 'interventionNames': ['Other: Traditional therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Graded motor imagery', 'description': 'Cold-Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, graded motor imagery training (body right-left discrimination exercise, imagining the movement and exercising the opposite limb in front of the mirror).', 'interventionNames': ['Other: Graded motor imagery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nintendo Wİİ', 'description': 'Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, games involving your relevant shoulder such as boxing and bowling on the Nintendo Wii game console.', 'interventionNames': ['Other: Nintendo Wİİ']}], 'interventions': [{'name': 'Traditional therapy', 'type': 'OTHER', 'description': 'Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises', 'armGroupLabels': ['Traditional therapy']}, {'name': 'Graded motor imagery', 'type': 'OTHER', 'description': 'Cold-Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, graded motor imagery training (body right-left discrimination exercise, imagining the movement and exercising the opposite limb in front of the mirror).', 'armGroupLabels': ['Graded motor imagery']}, {'name': 'Nintendo Wİİ', 'type': 'OTHER', 'description': 'Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, games involving your relevant shoulder such as boxing and bowling on the Nintendo Wii game console.', 'armGroupLabels': ['Nintendo Wİİ']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34519', 'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University- Cerrahpaşa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Cansu Ercan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unaffiliated"'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'November 2024 - November 2025', 'ipdSharing': 'YES', 'description': 'All collected IPD, all IPD that underlie results in a publication', 'accessCriteria': 'Healthcare professionals doing research in this field'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cansu ERCAN', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}