Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-25 @ 9:04 PM
Study NCT ID:
NCT06047756
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2023-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hippotherapy Versus Swiss Ball Training to Improve Trunk Control and Balance on Spastic Daiplegic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056147', 'term': 'Equine-Assisted Therapy'}], 'ancestors': [{'id': 'D056447', 'term': 'Animal Assisted Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Randomized'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2023-09-14', 'studyFirstSubmitQcDate': '2023-09-14', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gross Motor Functional Scale', 'timeFrame': '6weeks', 'description': 'Changes from baseline The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy.Greater score means higher functional level'}, {'measure': 'Trunk Control Measurement Scale', 'timeFrame': '6 weeks', 'description': 'Changes from Baseline The TCMS scale assesses seated trunk control in three dimensions. The maximum score is 58 points where 20 points correspond to static balance, 28 to selective movement control, and 10 to the ability to perform dynamic reaching'}, {'measure': 'Pediatric Balance Scale', 'timeFrame': '6 weeks', 'description': 'Changes from Baseline 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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy Spastic Diplegia']}, 'descriptionModule': {'briefSummary': 'To compare effect in both intervention', 'detailedDescription': 'In this study we will compare the effects of hippotherapy and swiss ball therapy. Our objectives of the study are To compare the effects of hippotherapy and Swiss ball training, to improve trunk control and balance on spastic diplegic cerebral palsy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:• Children (male and female)\n\n* Age group 4 to 11 years\n* Subject diagnosed with CP\n* Mild Spastic Diaplegic of the lower limbs according to the modified ashworth scale grade 1 to 1+\n* GMFM scale sitting balance score less than 20\n* Medically stable and able to understand commands\n\nExclusion Criteria:• Children with mental retardation,\n\n* Epilepsy, other associated neurological disorders, other type of cerebral palsy,\n* Attention deficit hyperactivity disorder and sensory issues(poor visual or hearing acuity)'}, 'identificationModule': {'nctId': 'NCT06047756', 'briefTitle': 'Hippotherapy Versus Swiss Ball Training to Improve Trunk Control and Balance on Spastic Daiplegic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Hippotherapy Versus Swiss Ball Training to Improve Trunk Control and Balance on Spastic Daiplegic Child', 'orgStudyIdInfo': {'id': 'REC/00123Mehrin Wadood'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hippotherapy', 'description': 'Patients suffering with diplegic therapy will perform their exercise protocols on a stationary horse.The child is seat astride the horse wearing a helmet and was encouraged to perform various activities designed to emphasize movement in a forward and upward reaching direction to encourage active postural control, trunk strength, balance and trunk/pelvic dissociation.30 minutes to 1 hour with a frequency ranging from 4 sessions per week and the total duration of horseback riding 6 weeks.', 'interventionNames': ['Other: Hippotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Swiss Ball therapy', 'description': 'Children of second group will receive swiss ball therapy. Position the child to sit on the ball and giving extension rotation and flexion rotation to the child. This will facilitate trunk rotation by which the upper body is towards the weight bearing hip and away from the weight bearing hip.Training program 4 times per weeks with the treatment session of 30 minutes for 6 weeks duration', 'interventionNames': ['Other: Swiss Ball therapy']}], 'interventions': [{'name': 'Hippotherapy', 'type': 'OTHER', 'description': 'Patient will perform different movement of the trunk while sitting on a horse.', 'armGroupLabels': ['Hippotherapy']}, {'name': 'Swiss Ball therapy', 'type': 'OTHER', 'description': 'Patient will perform movements of trunk on swiss ball', 'armGroupLabels': ['Swiss Ball therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Dīr', 'state': 'Khyberpakhtunkhuwa', 'country': 'Pakistan', 'facility': 'Helping hand for relief and development', 'geoPoint': {'lat': 35.2074, 'lon': 71.8768}}], 'overallOfficials': [{'name': 'Ayesha Bashir, MSNMPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah international University Islamabad'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}