Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-29 @ 3:56 AM
Study NCT ID:
NCT06217835
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2023-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What Are the Effects of Lower Limb Dysmetria on Gluteus Medius and Erector Spinae Musculature?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D007870', 'term': 'Leg Length Inequality'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-29', 'studyFirstSubmitDate': '2023-12-04', 'studyFirstSubmitQcDate': '2024-01-11', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Height CMJ', 'timeFrame': '1 week', 'description': 'CMJ jump flight height'}, {'measure': 'Height DJ LEFT', 'timeFrame': '1 week', 'description': 'Flying height in drop jump left leg'}, {'measure': 'Height DJ RIGHT', 'timeFrame': '1 week', 'description': 'Flying height in drop jump right leg'}, {'measure': 'Gluteus medius (mv)', 'timeFrame': '1 week', 'description': 'Gluteus medius activation (mv)'}, {'measure': 'Erector Spinae (mv)', 'timeFrame': '1 week', 'description': 'Erector Spinae activation (mv)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low Back Pain', 'electromyography', 'Leg Length Inequality', 'lower limb length'], 'conditions': ['Muscular Disorders, Atrophic']}, 'descriptionModule': {'briefSummary': 'Gluteus Medius (GM) has also been implicated in the development of Low Back Pain (LBP). GM is one of the main pelvic, where he actively participates in control of motion in the frontal and transverse plane, and hip , improving stability to the lumbopelvic-hip complex.\n\nThe aim of present study was to investigate whether modifying lower limb length with a different foot insoles of 0.5, 1 and 1.5 cm in a normal population has an effect on ES and GM activity and as a consequence in LBP. As a secondary objective, in turn, to evaluate whether ES and GM activity has an effect on jumping ability as assessed through CMJ.', 'detailedDescription': 'Background: Length leg discrepancy (LLD), regardless of its origin, is a very common pathology that can contribute to low back pain. Various authors point out its relationship with the lack of activation of both the gluteus medius (GM) and the ipsilateral erector spinae (ES). The purpose of this study was to identify the activation of Es and GM with different simulated LLD, correlating said activation with the LBP. In turn, to evaluate whether ES and GM activity has an effect on jumping ability as assessed through CMJ. (2) Method: a sample of healthy subjects was selected to whom an artificial LLD was incorporated through a 0.5, 1 and 1.5 cm insole, measuring with EMGs in these 3 moments while walking and performing a counter movement jump (CMJ). The measurement was carried out in random order, in terms of insole height, using a Latin Square. Muscle activation patterns were recorded for 30 seconds at each of the insole heights while walking at 5.7 km/h and compared with the maximum voluntary contraction (MVC), both on the ipsilateral and contra-lateral sides. These muscles were then measured under the same circumstances during the development of the CMJ. (3)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* The volunteers had no problems in range of motion of joints of the lower limbs\n* pelvic obliquity due to a functional leg length discrepancy.\n* obesity with body mass index (BMI) 35 \\> kg/m²'}, 'identificationModule': {'nctId': 'NCT06217835', 'acronym': 's-EMG', 'briefTitle': 'What Are the Effects of Lower Limb Dysmetria on Gluteus Medius and Erector Spinae Musculature?', 'organization': {'class': 'OTHER', 'fullName': 'Camilo Jose Cela University'}, 'officialTitle': 'Changes in Activity of Erector Spinae and Gluteus Medius Muscles With the Presence of Simulated Lower Limb Dysmetria', 'orgStudyIdInfo': {'id': 'CamiloJcU-Fisio'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0,5 cm jig', 'description': 'A template with the dimensions indicated is introduced to the user and he/she walks for 1 minute.', 'interventionNames': ['Other: To evaluate the response of an orthopedic insole', 'Other: evaluate activation of musculature']}, {'type': 'EXPERIMENTAL', 'label': '1 cm jig', 'description': 'A template with the dimensions indicated is introduced to the user and he/she walks for 1 minute.', 'interventionNames': ['Other: To evaluate the response of an orthopedic insole', 'Other: evaluate activation of musculature']}, {'type': 'EXPERIMENTAL', 'label': '1,5 cm jig', 'description': 'A template with the dimensions indicated is introduced to the user and he/she walks for 1 minute.', 'interventionNames': ['Other: To evaluate the response of an orthopedic insole', 'Other: evaluate activation of musculature']}], 'interventions': [{'name': 'To evaluate the response of an orthopedic insole', 'type': 'OTHER', 'description': 'To evaluate the response of an orthopedic insole of different heights on gait.', 'armGroupLabels': ['0,5 cm jig', '1 cm jig', '1,5 cm jig']}, {'name': 'evaluate activation of musculature', 'type': 'OTHER', 'description': 'To evaluate the response caused by an orthopedic insole of different heights on the indicated musculature.', 'armGroupLabels': ['0,5 cm jig', '1 cm jig', '1,5 cm jig']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Villanueva de la Cañada', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Juan Hernández Lougedo', 'geoPoint': {'lat': 40.44689, 'lon': -4.00428}}], 'overallOfficials': [{'name': 'Eduardo Cimadevilla, PT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Camilo Jose Cela University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Camilo Jose Cela University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}