Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT05873166
Status:
COMPLETED
Last Update Posted:
2023-06-01
First Post:
2023-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stabilometry After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser: Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005413', 'term': 'Flatfoot'}], 'ancestors': [{'id': 'D000070558', 'term': 'Talipes'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005532', 'term': 'Foot Deformities, Congenital'}, {'id': 'D038061', 'term': 'Lower Extremity Deformities, Congenital'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-31', 'studyFirstSubmitDate': '2023-05-15', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stabilometry variables eyes open before pressure release (x)', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in X (in millimeters) with open eyes.'}, {'measure': 'Stabilometry variables eyes open before pressure release (y)', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in Y (in millimeters) with open eyes.'}, {'measure': 'Stabilometry variables eyes open before pressure release COP area', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of Pressure (COP) area (in millimeters2) with eyes open.'}, {'measure': 'Stabilometry variables eyes open before pressure release COP a-p', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in millimeters/second).'}, {'measure': 'Stabilometry variables eyes open before pressure release COP lat-lat', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in millimeters/second).'}, {'measure': 'Stabilometry variables eyes closed after pressure release (x)', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in X (in millimeters) with eyes closed.'}, {'measure': 'Stabilometry variables eyes closed after pressure release (y)', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in Y (in millimeters) with closed eyes.'}, {'measure': 'Stabilometry variables eyes closed after pressure release COP area', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of Pressure (COP) area (in millimeters²) with eyes closed.'}, {'measure': 'Stabilometry variables eyes closed after pressure release COP a-p', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in millimeters/second).'}, {'measure': 'Stabilometry variables eyes closed after pressure release COP lat-lat', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in millimeters/second).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Foot', 'stabilometry', 'trigger point'], 'conditions': ['Flatfoot']}, 'descriptionModule': {'briefSummary': 'Thirty-six subjects randomly distributed between a pressure release intervention group and a control group whose intervention is a non-emission laser. All the subjects will be measured before and after the interventions of each group. The measurements will be made on a pressure platform to record the stabilometry variables.', 'detailedDescription': 'Thirty-six subjects randomly distributed between a pressure release intervention group and a control group whose intervention is a non-emission laser. All the subjects will be measured before and after the interventions of each group. The measurements will be made on a pressure platform to record the stabilometry variables with eyes closed and open.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have latent trigger point in Flexor Brevis Digitorum muscles with no other pathologies\n\nExclusion Criteria:\n\n* Previous lower extremities surgery. History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.\n\nLeg-length discrepancy more than 1 cm Balance deficits (determined by oral questionnaire regarding falls)'}, 'identificationModule': {'nctId': 'NCT05873166', 'briefTitle': 'Stabilometry After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser: Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Mayuben Private Clinic'}, 'officialTitle': 'Stabilometry After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser: Clinical Trial', 'orgStudyIdInfo': {'id': '1912202200923-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point', 'description': 'Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point', 'interventionNames': ['Other: Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point']}, {'type': 'SHAM_COMPARATOR', 'label': 'Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle', 'interventionNames': ['Other: Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle']}], 'interventions': [{'name': 'Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point', 'type': 'OTHER', 'description': 'Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point', 'armGroupLabels': ['Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point']}, {'name': 'Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle', 'type': 'OTHER', 'description': 'Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle', 'armGroupLabels': ['Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28702', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Eva María Martínez-Jimenez', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Eva María Martínez-Jimenez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayuben Private Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayuben Private Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Podiatry, Principal Investigator, and Physiotherapist.', 'investigatorFullName': 'EVA MARIA MARTÍNEZ JIMENEZ', 'investigatorAffiliation': 'Mayuben Private Clinic'}}}}