Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT05511012
Status:
UNKNOWN
Last Update Posted:
2023-07-13
First Post:
2022-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'It is a prospective, monocentric, exploratory study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2022-08-19', 'studyFirstSubmitQcDate': '2022-08-19', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of compensation motion : "waiters bow" test', 'timeFrame': 'Day 0', 'description': 'Lumbar flexion measured for test number 1 "waiters bow". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal'}, {'measure': 'Range of compensation motion : "pelvic tilt" test', 'timeFrame': 'Day 0', 'description': 'thoracic flexion measured for test number 2 "pelvic tilt". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.'}, {'measure': 'Range of compensation motion : "One leg stance" test', 'timeFrame': 'Day 0', 'description': 'Pelvic shift measured for test number 3 "One leg stance ". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.'}, {'measure': 'Range of compensation motion : "sitting knee extension" test', 'timeFrame': 'Day 0', 'description': 'Lumbar flexion measured for test number 4 "sitting knee extension". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.'}, {'measure': 'Range of compensation motion : "rocking 4 point kneeling" test', 'timeFrame': 'Day 0', 'description': 'Lumbar flexion and extension measured for test number 5 "rocking 4 point kneeling ". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.'}, {'measure': 'Range of compensation motion : "prone knee bend" test', 'timeFrame': 'Day 0', 'description': 'Lumbar extension measured for test number 6 "prone knee bend". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal'}], 'secondaryOutcomes': [{'measure': 'Speed of execution for test 1', 'timeFrame': 'Day 0', 'description': 'It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.'}, {'measure': 'Speed of execution for test 2', 'timeFrame': 'Day 0', 'description': 'It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.'}, {'measure': 'Speed of execution for test 3', 'timeFrame': 'Day 0', 'description': 'It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.'}, {'measure': 'Speed of execution for test 4', 'timeFrame': 'Day 0', 'description': 'It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.'}, {'measure': 'Speed of execution for test 5', 'timeFrame': 'Day 0', 'description': 'It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.'}, {'measure': 'Speed of execution for test 6', 'timeFrame': 'Day 0', 'description': 'It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low back pain', 'Movement control', 'Kinematic analysis', 'Clinical assessment'], 'conditions': ['Chronic Low-back Pain']}, 'descriptionModule': {'briefSummary': '* Exercise-based treatment is part of the recommendations for good practice in the treatment of low back pain (acute, sub-acute and chronic).\n* The low back pain population is heterogeneous. This heterogeneity would cause the positive effects of a treatment to be canceled out by the negative effects of another part of the population.\n* This polymorphism has led several authors to classify low back pain into subgroups. These subgroups constitute more homogeneous clinical pictures and would facilitate the adaptation of treatments.\n* The recommendations of the American Physical Therapy Association suggest 5 subgroups of low back pain. One of them is "low back pain with movement coordination defect". In this subgroup, Luomajoki studied the reliability of different functional tests used in clinical practice. 6 out of 10 motion control fault tests show good reliability.\n* The quantified analysis of the movement of low back pain patients would make it possible to determine the sensitivity of detecting an anomaly in the 6 lumbar movement control tests.', 'detailedDescription': '* Exercise-based treatment is part of the recommendations for good practice in the treatment of low back pain (acute, sub-acute and chronic).\n* The low back pain population is heterogeneous. This heterogeneity would cause the positive effects of a treatment to be canceled out by the negative effects of another part of the population.\n* This polymorphism has led several authors to classify low back pain into subgroups. These subgroups constitute more homogeneous clinical pictures and would facilitate the adaptation of treatments.\n* The recommendations of the American Physical Therapy Association suggest 5 subgroups of low back pain. One of them is "low back pain with movement control impairment". In this subgroup, Luomajoki studied the reliability of different functional tests used in clinical practice. 6 out of 10 motion control fault tests show good reliability.\n* The quantified analysis of the movement of low back pain patients would make it possible to determine the sensitivity of detecting an anomaly in the 6 lumbar movement control tests.\n\nLoBaCoM is a monocentric, exploratory prospective study.\n\nThe purpose is to define a kinematic (angular) threshold corresponding to an anomaly detected clinically by three therapists for each test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged more than 18 years\n* Common low back pain with medical prescription for rehabilitation\n* Signed consent\n* Be affiliated to a social security scheme\n* Be able to perform the lumbar motion control failure tests\n\nExclusion Criteria:\n\n* Body Mass Index greater than 30 (obesity)\n* Person who does not understand French\n* Pregnant woman\n* Refusal to participate\n* Volunteer under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT05511012', 'acronym': 'LOBACOM', 'briefTitle': "Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': "Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification", 'orgStudyIdInfo': {'id': '29BRC22.0128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'motion control fault testing', 'description': 'Each patient make six motion control fault tests in the same order :\n\n1. "waiters bow"\n2. "pelvic tilt"\n3. "one leg stance"\n4. "sitting knee extension"\n5. "rocking 4 point kneeling"\n6. "prone knee bend"\n\nThis tests are performed three times.', 'interventionNames': ['Other: motion control fault tests']}], 'interventions': [{'name': 'motion control fault tests', 'type': 'OTHER', 'description': 'Patients make 6 motion control fault tests, in the same order. Each test is performed three times', 'armGroupLabels': ['motion control fault testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'state': 'Finistère', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': "Vincent CREAC'H", 'role': 'CONTACT', 'email': 'vincent.creach@univ-brest.fr', 'phone': '+33(0)298017935'}, {'name': 'Marine BOURHIS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fanny GARGADENNEC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thimothée HOUGRON', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'centralContacts': [{'name': "Vincent CREAC'H", 'role': 'CONTACT', 'email': 'vincent.creach@univ-brest.fr', 'phone': '+33(0)298017935'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available after the publication of result and ending fifteen years following the last visit of the last patient', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}