Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-03 @ 10:17 AM
Study NCT ID:
NCT02435134
Status:
COMPLETED
Last Update Posted:
2017-02-14
First Post:
2015-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examination Chair for Hip Internal Rotation Range of Motion Measurement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-13', 'studyFirstSubmitDate': '2015-04-27', 'studyFirstSubmitQcDate': '2015-05-05', 'lastUpdatePostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hip internal rotation range of motion angle (degrees)', 'timeFrame': '7 days', 'description': 'Participants will be tested for hip internal range of motion using three different methods. The measurements will be repeated 7 days after the initial measurement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Limited Hip Mobility']}, 'descriptionModule': {'briefSummary': 'Hip internal rotation range of motion (HIRROM) assessment is performed to assess the mobility of the hip. The assessment is typically done manually (manual testing), which induces large variability in the results between and within testers. An initial version of an examination chair (EC1) was recently developed with the aim to minimize the variability of testing results for HIRROM assessments. A new version of the examination chair (EC2) has been implemented in order to individualize the testing protocol and will be validated in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy participants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants are pain free in the lower extremity, hip and back\n* Participants signed the consent form\n\nExclusion Criteria:\n\n* Participant requires pain relief medication\n* History of hip surgery\n* Neuromuscular disorders\n* Legal incompetence'}, 'identificationModule': {'nctId': 'NCT02435134', 'acronym': 'HIRROM', 'briefTitle': 'Examination Chair for Hip Internal Rotation Range of Motion Measurement', 'organization': {'class': 'OTHER', 'fullName': 'Schulthess Klinik'}, 'officialTitle': 'Validation of a Test Protocol for Measuring the Hip Internal Rotation Range of Motion Using a Newly Developed Examination Chair', 'orgStudyIdInfo': {'id': 'HIRROM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy participants', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'armGroupLabels': ['Healthy participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Schulthess Klinik', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schulthess Klinik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}