Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-31 @ 3:42 AM
Study NCT ID:
NCT04412603
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2020-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emergent Therapies in OBP. Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000076984', 'term': 'Neonatal Brachial Plexus Palsy'}], 'ancestors': [{'id': 'D020516', 'term': 'Brachial Plexus Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001720', 'term': 'Birth Injuries'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A pilot randomized clinical trial was performed with simple blind and randomization of block assignmen.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-31', 'studyFirstSubmitDate': '2020-02-19', 'studyFirstSubmitQcDate': '2020-06-01', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's Hand-use Experience Questionnaire", 'timeFrame': 'Four weeks', 'description': 'To measure the affected upper limb spontaneous use, validated for children with unilateral involvement or disuse of one of their upper limbs from 6 to 18 years in which the experience of children using the affectected upper limb.'}, {'measure': 'Pediatric Quality of Life Inventory Generic Core Scales PedsQLTM 4.0', 'timeFrame': 'Four weeks', 'description': 'Modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality.', 'family', 'Mirror Therapy', 'Obstetrical Brachial Palsy', 'Upper extremity'], 'conditions': ['Neonatal Brachial Plexus Palsy']}, 'descriptionModule': {'briefSummary': "Obstetric Brachial Palsy (OBP) produces functional limitations in the involvement of the affected upper limb within the child's natural environment. The therapeutic interventions of Conventional Mirror Therapy (MT) and Mirror Therapy Virtual Reality (VR) are aimed at the rehabilitation of the affected upper limb and the quality life improvement.\n\nTo quantify the increase in the affected upper limb spontaneous use and the quality of life of children with upper OBP from 6-12 years, when They are treated with Conventional MT or Mirror Therapy VR applying specific protocol: 20 min/day in 4 weeks.", 'detailedDescription': 'The intervention protocol was permorfed for four weeks, three days per week applying Conventional Mirror Therapy or Mirror Therapy Virtual Reality, with 20-minute sessions in 4 weeks. Designed to be done at home.\n\nTwo measurements of the affected upper limb spontaneous use and quality of life were performed, a pre-treatment assessment corresponding to the baseline situation, and another post-treatment Assessment to observe the results after the therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages between 6 and 12 years old, upper Obstetric Brachial Palsy type Erb-Duchenne (C5-C6) and extended Erb-Duchenne (C5-C7), preserved functionality to do the activities, adequate cognitive level to follow the proposed activities.\n\nExclusion Criteria:\n\n* associated pathologies, medical complications or cognitive and / or visual impairment that prevent the activities performance, affected upper limb surgeries in the last year, treatment with botulinum toxin in the last three months, no possession of a device with Android operating system for the application of Virtual Reality therapy, families and children no partners.'}, 'identificationModule': {'nctId': 'NCT04412603', 'briefTitle': 'Emergent Therapies in OBP. Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'CEU San Pablo University'}, 'officialTitle': 'Conventional Mirror Therapy and Mirror Therapy Virtual Reality in Obstetric Brachial Palsy: Pilot Study', 'orgStudyIdInfo': {'id': 'Obstetric Brachial Palsy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional Mirror Therapy group', 'description': 'Therapy:\n\n-With the affected upper limb into the mirror box, perform the exercise with the non-affected extremity which is reflected in the mirror box. -The affected side must perform the corresponding movement within its possibilities, according to the exercise that is being performed with the healthy arm. - It is very important to look at the mirror at all times, which reflects the non-affected side while doing the exercises.', 'interventionNames': ['Other: Conventional Mirror Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Mirror Therapy Virtual Reality group', 'description': 'Therapy:\n\n-Perform the exercises with the non-affected limb, which must be watched constantly with virtual reality glasses, to interpret that this limb corresponds to the affected side. - The affected side accompanies the movement within its possibilities (out of sight of the patient, it can be covered with a handkerchief). - It is very important to look at the non-affected side. The affected side should be out of the visual field to avoid confusion.', 'interventionNames': ['Other: Conventional Mirror Therapy']}], 'interventions': [{'name': 'Conventional Mirror Therapy', 'type': 'OTHER', 'otherNames': ['Mirror Therapy Virtual Reality'], 'description': 'The Conventional Mirror Therapy was carried out with a mirror box and the Mirror Therapy Virtual Reality was carried out with virtual reality glasses and mobile application: Mirror Therapy VR.', 'armGroupLabels': ['Conventional Mirror Therapy group', 'Mirror Therapy Virtual Reality group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28668', 'city': 'Madrid', 'country': 'Spain', 'facility': 'San Pablo-CEU Univerity', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Rocío Palomo, Physiotherapist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'San Pablo-CEU Univerity'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CEU San Pablo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}