Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT04538118
Status:
COMPLETED
Last Update Posted:
2020-09-07
First Post:
2020-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship of Patient-Specific Functional Scale With Shoulder Functions: A Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D002062', 'term': 'Bursitis'}, {'id': 'D006810', 'term': 'Humeral Fractures'}, {'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'targetDuration': '6 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-04', 'studyFirstSubmitDate': '2020-08-28', 'studyFirstSubmitQcDate': '2020-09-02', 'lastUpdatePostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability', 'timeFrame': '6 weeks', 'description': 'Disability was evaluated with Patient-Specific Functional Scale.Patients nominate 3 to 5 activities that they are unable to do or having difficulty doing because of their injury or problem. These activities are rated on an 11-point scale, where 0 is unable to perform the activity and 10 is able to perform the activity at preinjury level.'}, {'measure': 'Activity Limitation', 'timeFrame': '6 weeks', 'description': 'Activity limitation was evaluated with The Disabilities of the Arm, Shoulder and Hand. Scale score ranges from 0 (no disability) to 100 (most severe disability).'}, {'measure': 'Functional Disorder', 'timeFrame': '6 weeks', 'description': 'Disability was evaluated with Upper-Extremity Functional Index.Twenty prescribed upper extremity activities are rated by patients according to a 5-point scale, where 0 is extreme difficulty or unable to perform the activity, and 4 is no difficulty. Higher scores mean better outcome scores.'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '6 weeks', 'description': 'Pain was evaluated with Numeric Pain Rating Scale. It requires the patient to rate their pain on a defined scale. 0-10 where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Range of Motion', 'timeFrame': '6 weeks', 'description': 'Shoulder range of motion was evaluated with universal goniometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Impingement', 'Frozen Shoulder', 'Humeral Fractures', 'Rotator Cuff Tears', 'Disability Physical', 'Pain, Shoulder']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine the relationship between the Patient- Specific Functional Scale (PSFS) and shoulder functions in the physiotherapy and rehabilitation program applied to patients with shoulder problems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with shoulder problems', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having a shoulder pathology\n* being volunteer\n* having shoulder pain at least 3 months\n* being literate\n\nExclusion Criteria:\n\n* having more than one upper extremity pathology\n* having an upper extremity pathology involving the neck and trunk\n* having a neurological finding'}, 'identificationModule': {'nctId': 'NCT04538118', 'briefTitle': 'Relationship of Patient-Specific Functional Scale With Shoulder Functions: A Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': 'Relationship of Patient-Specific Functional Scale With Shoulder Functions in Physiotherapy and Rehabilitation Program Applied to Patients With Shoulder Problems', 'orgStudyIdInfo': {'id': '363-37'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with a shoulder problem', 'description': 'Patients with shoulder problems between 18-65 years of age and being volunteered', 'interventionNames': ['Behavioral: Shoulder disability', 'Device: Shoulder Range of Motion', 'Behavioral: Pain Intensity']}], 'interventions': [{'name': 'Shoulder disability', 'type': 'BEHAVIORAL', 'description': 'Shoulder disability was evaluated with Patient-specific functional scale, the disabilities of the shoulder, arm and hand questionnaire, and the upper extremity functional index.\n\nFirst assessment was applied when patients came to physical therapy clinic at first.\n\nSecond assessment was repeated after 6 weeks.', 'armGroupLabels': ['Patient with a shoulder problem']}, {'name': 'Shoulder Range of Motion', 'type': 'DEVICE', 'description': 'Shoulder range of motion was evaluated with universal goniometer. First assessment was applied when patients came to physical therapy clinic at first.\n\nSecond assessment was repeated after 6 weeks.', 'armGroupLabels': ['Patient with a shoulder problem']}, {'name': 'Pain Intensity', 'type': 'BEHAVIORAL', 'description': 'Pain intensity was evaluated with Numeric Pain Rating Scale. First assessment was applied when patients came to physical therapy clinic at first.\n\nSecond assessment was repeated after 6 weeks.', 'armGroupLabels': ['Patient with a shoulder problem']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Yıldırım Beyazıt University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Hidayet Cuha, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Ankara Yildirim Beyazıt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}