Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
Study NCT ID:
NCT06721650
Status:
RECRUITING
Last Update Posted:
2024-12-06
First Post:
2024-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perturbation-Based Balance Training on Trunk Proprioception and Balance in Cerebral Palsy:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BIODEX balance system', 'timeFrame': 'three months', 'description': "to evaluate postural balance. The BBS is a multiaxial device that objectively measures and records an individual's ability to stabilize the involved joint under dynamic stress."}, {'measure': 'Pediatric Balance Scale', 'timeFrame': 'three months', 'description': 'The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points'}, {'measure': 'baseline digital inclinometer.', 'timeFrame': 'four weeks', 'description': 'for measuring lateral movement in applications like: Earth movement in the landslide zone. Detecting shear planes in hydraulic structures. Measuring stability during construction'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of Perturbation-Based Balance Training on trunk proprioception and balance in hemiparetic cerebral palsy', 'detailedDescription': 'Thirty-eight patients with hemiplegic cerebral palsy will participate in this study.\n\nThe patients will randomly be divided into two equal groups; the control group which received the selected physical therapy exercise program and the study group received the same exercise training program in addition to Perturbation-Based Balance Training, three times per week for three months. The evaluation methods are BIODEX, The Pediatric Balance Scale, baseline digital inclinometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Thirty-eight children hemiplegic cerebral palsy\n* Age will range as (8:10) years old\n* Spastic hemiplegic cerebral palsy\n* Normal body mass index ranged from 1SD to -2SDaccording to BMI-for age Z score charts include an age and sex- specific BMI for children (WHO, 2007).\n* Gross motor function classification system: level I\\&II\n\nExclusion Criteria:\n\n* • Difficulty to communicate or to understand program instructions\n\n * any other neurological deficits or orthopaedic abnormalities,\n * secondary musculoskeletal complication\n * vestibular problems\n * any mental impairment'}, 'identificationModule': {'nctId': 'NCT06721650', 'briefTitle': 'Perturbation-Based Balance Training on Trunk Proprioception and Balance in Cerebral Palsy:', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Effect of Perturbation-Based Balance Training on Trunk Proprioception and Balance in Hemiplegic Cerebral Palsy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005471'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'study group', 'interventionNames': ['Other: Perturbation-Based Balance Training', 'Other: the selected physical therapy exercise program']}, {'type': 'OTHER', 'label': 'control group', 'interventionNames': ['Other: the selected physical therapy exercise program']}], 'interventions': [{'name': 'Perturbation-Based Balance Training', 'type': 'OTHER', 'description': 'Perturbation-based balance training (PBT; or reactive balance training or perturbation training) is balance training that uses repeated, externally applied mechanical perturbations to trigger rapid reactions to regain postural stability in a safe and controlled environment', 'armGroupLabels': ['study group']}, {'name': 'the selected physical therapy exercise program', 'type': 'OTHER', 'description': 'trunk control therapeutic exercise, static and dynamic balance treaining exercises', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'state': 'El-Sheikh Zayed City Giza 1133 Egypt', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'faculty of physical therapy October 6 University', 'role': 'CONTACT', 'email': 'pt@o6u.edu.eg', 'phone': '0238362496'}], 'facility': 'October 6 University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Lama Saad El-Din ED Mahmoud, PHD', 'role': 'CONTACT', 'email': 'lamaelsedawyy@hotmail.com', 'phone': '01157592636'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lama Saad El-Din Mahmoud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Neurology and Neurosurgery Faculty of Physical Therapy October 6 University', 'investigatorFullName': 'Lama Saad El-Din Mahmoud', 'investigatorAffiliation': 'October 6 University'}}}}