Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-01-01 @ 9:37 PM
Study NCT ID:
NCT07244159
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Dynamic Surface Exercise Training in Children With Diplegic 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': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will get separate treatment protocols efforts will be put to mask the both groups about the treatment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized clinical trial,total of 14 children with diplegic cerebral palsy of age between 6 and 8 years of both genders with Gross Motor Function Classification System of level III and IV will be recruited to participate in randomized controlled study. The study will be completed within 10 months after the approval of the synopsis. Technique of the study is non-probability convenient sampling technique. Recruited will be randomly divided into two groups, dynamic surface exercise training (DSET) group and standard physiotherapy training group. Both the groups receive active training program lasting for 60 minutes, 4 days/week for 6 weeks who have the ability to follow and accept verbal instructions. Gross Motor Function Measure (GMFM)-88 and Pediatric Balance Scale (PBS) and Time up and go test scores will be recorded at baseline, and at the end of 6-week post-intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gross Motor Function Measure (GMFM)', 'timeFrame': 'baseline, 1st week and 6th week', 'description': 'Balance Scale (PBS) will be the outcome measures use in this trial. GMFM-88 has excellent relative reliability of excellent (Intraclass correlation coefficient (ICC) = 0.952-1.000)'}, {'measure': 'Pediatric Berg Balance Scale', 'timeFrame': 'baseline, 1st week and 6th week', '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'}, {'measure': 'Time up and go test', 'timeFrame': 'baseline, 1st week and 6th week', 'description': 'Reliability of TUG test was high, with ICC of 0.99 for within-session reliability and 0.99 for test-retest reliability'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diplegic cerebral palsy', 'Dynamic surface exercise training', 'Balance', 'Coordination', 'Gross Motor Function Measure (GMFM)'], 'conditions': ['Child, Only']}, 'referencesModule': {'references': [{'pmid': '36415346', 'type': 'BACKGROUND', 'citation': 'Salphale VG, Kovela RK, Qureshi MI, Harjpal P. Effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation on Balance and Gait Parameters in Children With Spastic Diplegia. Cureus. 2022 Oct 22;14(10):e30571. doi: 10.7759/cureus.30571. eCollection 2022 Oct.'}]}, 'descriptionModule': {'briefSummary': 'Data will be collected after the approval of synopsis a total of 14 children with diplegic cerebral palsy of age between 6 and 8 years of both genders with Gross Motor Function Classification System of level III and IV will be recruited to participate in randomized controlled study. The study will be completed within 10 months after the approval of the synopsis. Technique of the study is non-probability convenient sampling technique. Recruited will be randomly divided into two groups, dynamic surface exercise training (DSET) group and standard physiotherapy training group. Both the groups receive active training program lasting for 60 minutes, 4 days/week for 6 weeks who have the ability to follow and accept verbal instructions. Gross Motor Function Measure (GMFM)-88 and Pediatric Balance Scale (PBS) and Time up and go test scores will be recorded at baseline, and at the end of 6-week post-intervention.', 'detailedDescription': 'This group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks. For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) . The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3e5 s, followed by a slow relaxation phase, with 10e20 repetitions) and prone bridging (the entire sequence was repeated 3e5 times).\n\nThis group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks. Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day. On bench, patient forward bend and pick the ball, come back to sitting and through the ball for 10 times and 1 set. On floor, standing: throwing and catching the ball from different direction, 10 times each side, 1 set Gross motor function measure-88 and pediatric balance scale and time up and go test scores will be recorded at baseline, and at the end of 6-week post-intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 5 and 8 years of both genders\n* Classification as level III and IV on the Gross Motor Function Classification system (GMFCS)\n\nExclusion Criteria:\n\n* • Any orthopedic surgery or botulinum toxin injection in the past 6 months.\n\n * Refusal by the parents to participate.'}, 'identificationModule': {'nctId': 'NCT07244159', 'briefTitle': 'Effects of Dynamic Surface Exercise Training in Children With Diplegic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Dynamic Surface Exercise Training on Functional Mobility, Balance and Coordination in Children With Diplegic Cerebral Palsy', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/HAFIZA IRAM BATOOL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'This group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks. For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) . The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions)', 'interventionNames': ['Other: Dynamic surface exercise training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'This group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks. Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day. On bench, patient forward bend and pick the ball, come back to sitting and through the ball for 10 times and 1 set', 'interventionNames': ['Other: Standard physiotherapy Training']}], 'interventions': [{'name': 'Dynamic surface exercise training', 'type': 'OTHER', 'description': 'This group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks. For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) . The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3e5 s, followed by a slow relaxation phase, with 10e20 repetitions) and prone bridging (the entire sequence was repeated 3e5 times.', 'armGroupLabels': ['Group A']}, {'name': 'Standard physiotherapy Training', 'type': 'OTHER', 'description': 'This group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks. Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day.', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Muhammad Asif Javed, MS-PT', 'role': 'CONTACT', 'email': 'a.javed@riphah.edu.pk', 'phone': '923224209422'}], 'facility': 'Hafiza Iram Batool', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'IMRAN AMJAD, Phd', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '9233224390125'}, {'name': 'Muhammad Asif Javed, MS-PT', 'role': 'CONTACT', 'email': 'a.javed@riphah.edu.pk', 'phone': '923224209422'}], 'overallOfficials': [{'name': 'Hafiza Iram Batool, MS-PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}