Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-01-05 @ 6:11 PM
Study NCT ID:
NCT06198257
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2023-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effects of Spider Cage Therapy and Modified Suit Therapy in CP
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': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will get seperate treatment protocols and possible efforts will be put to mask the both groups about their treatment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'It will be Randomized Controlled trial in which non probability convenience sampling technique will be used. Two groups of 8 to 12 age will be formed in which participants will be randomly divided by lottery method. Group A will be given modified Thera suits and the other group B will receive spider cage therapy on trunk stability and pelvic control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2023-12-26', 'studyFirstSubmitQcDate': '2023-12-26', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trunk Impairment Scale (TIS).', 'timeFrame': '8 weeks', 'description': 'The static subscale. The dynamic subscale\n\nFor each item, a 2-, 3- or 4-point ordinal scale is used. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance. In a recent version of the TIS (version 2.0) for adults, the static subscale was removed because of a ceiling effect, total score ranges between 0 and 16 points.'}], 'secondaryOutcomes': [{'measure': 'Trunk Control Measurement Scale (TCMS).', 'timeFrame': '8 weeks', 'description': '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 TCMS sub scores appeared to be clinically relevant because children with less than around 80% of the static balance score, less than 55% of the dynamic reaching score, or less than around 35% of the selective movement control score needed support for daily life activities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CP', 'Pelvic control', 'Spider cage therapy', 'modified Thera suits'], 'conditions': ['Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '26613800', 'type': 'BACKGROUND', 'citation': 'Martins E, Cordovil R, Oliveira R, Letras S, Lourenco S, Pereira I, Ferro A, Lopes I, Silva CR, Marques M. Efficacy of suit therapy on functioning in children and adolescents with cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2016 Apr;58(4):348-60. doi: 10.1111/dmcn.12988. Epub 2015 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'Spider Cage is a part of universal exercise unit. It is a suspension system, which works with use of belts, elastic cords and Thera suits (Thera suits especially for cerebral palsy). Cords are dynamic and provides an appropriate amount of support with the help of which patient can perform movement independently. Cerebral Palsy (CP) is a condition where non progressive disorders of posture caused by abnormal development of, or damage to, motor control centers of brain resulting in abnormal movements.', 'detailedDescription': 'It will be Randomized Controlled trial in which non probability convenience sampling technique will be used. Two groups of 8 to 12 age will be formed in which participants will be randomly divided by lottery method. Group A will be given modified Thera suits and the other group B will receive spider cage therapy on trunk stability and pelvic control. Improvement will be identified by Trunk Control Measurement Scale (TCMS), Trunk impairment scale (TIS) and Gross motor function classification system. (GMFCS) level I-II. The result after statistical analysis will show that which treatment will be more effective. Results will be analyzed on SPSS 29. Data analyzed by repeated measures ANOVA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • 8 to 12 years of age\n\n * Both male and female\n * Hemiplegic cerebral palsy according to (GMFCS) severity level I-II\n * Ability to follow instructions and participate in therapy session\n\nExclusion Criteria:\n\n* • Presence of any medical conditions that would severely limit a child's participation in the study as vision or hearing loss, cardiac anomalies.\n\n * severe cognitive impairments that would hinder the participant's ability to actively participate in therapy sessions.\n * Complicated systemic disorders.\n * Uncontrollable seizures.\n * Usage of Botulinum toxin A injection within 3 months of prior"}, 'identificationModule': {'nctId': 'NCT06198257', 'briefTitle': 'Comparative Effects of Spider Cage Therapy and Modified Suit Therapy in CP', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Comparative Effects of Spider Cage Therapy and Modified Suit Therapy on Trunk Stability and Pelvic Control in Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/23/0764'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'Spider cage therapy along with strengthening exercises', 'interventionNames': ['Device: spider cage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'Modified suits therapy along with strengthening exercise', 'interventionNames': ['Device: modified suits therapy']}], 'interventions': [{'name': 'spider cage', 'type': 'DEVICE', 'description': '5 days a week for an hour/daily with conventional exercises. Assisted sit to stand (10 to 15---15 to 20) Assisted weight shift (10 to 15---15 to 20) Assisted trunk rotation (10 to 15---15 to 20) Hip Abd / Add. exercises (10 to 15---15 to 20) Bridge exercises (10 to 15---15 to 20)', 'armGroupLabels': ['group A']}, {'name': 'modified suits therapy', 'type': 'DEVICE', 'description': '5 days a week for an hour/daily with conventional exercises. Assisted sit to stand (10 to 15---15 to 20) Assisted weight shift (10 to 15---15 to 20) Assisted trunk rotation (10 to 15---15 to 20) Hip Abd / Add. exercises (10 to 15---15 to 20) Bridge exercises (10 to 15---15 to 20)', 'armGroupLabels': ['group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Riphah International University', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Izzah Bukhtawar, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}