Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT07244133
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Powerball in Children With Down Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Clinical Trial (RCT) will be conducted on 28 children aged 6-10 years, diagnosed with Down Syndrome with reduced upper extremity endurance and coordination..\n\nAfter screening participants will undergo 3 weeks power ball endurance training session, consisting of structured, repetitive and goal directed activities. Power ball training 3 sessions per week with the duration of 30 mins each session. Group A will receive different upper extremity activities with power ball on static surface while Group B will receive same activities with power ball on dynamic surface using a BOSU ball. The whole session followed by warm up and cool down sessions for 5 minutes each. Endurance will be assessed through ABIL-HAND kids tool. To access the coordination BOT-2 subsets test will be used.\n\nData will be assessed using SPSS 27.0.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-16', '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': '2026-06-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ABIL-HAND', 'timeFrame': 'Baseline- 1st week and 3rd week', 'description': "ABIL-HAND Kids Tool is used for the assessment of upper extremity endurance. It's a parent-reported measure of a child's manual ability (unilateral and bilateral hand use) in everyday tasks. Parents rate each of 21 activities as Impossible / Difficult / Easy. The item difficulty increases with bimanual involvement. The responses are expressed in form of logits. 0.90 is the reliability with a validity of 0.77"}], 'secondaryOutcomes': [{'measure': 'BOT-2', 'timeFrame': 'Baseline- 1st week and 3rd week', 'description': 'BOT-2 is a tool used for upper extremity coordination. This test is used to measures control and coordination of arm and hand movements. In this test visual and manual motor coordination (e.g., jumping, catching, throwing) will be assessed by performing different activities. The reliability of this tool is 0.86'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Down Syndrome (DS)', 'Powerball,', 'Upper extremity, Children'], 'conditions': ['Down Syndrome']}, 'referencesModule': {'references': [{'pmid': '38431591', 'type': 'BACKGROUND', 'citation': 'Blazquez-Fernandez A, Lopez-Hazas-Jimenez G, Fernandez-Vazquez D, Navarro-Lopez V, Fernandez-Gonzalez P, Marcos-Anton S, Molina-Rueda F, Cano-de-la-Cuerda R. Effects of the powerball(R) system on muscle strength, coordination, fatigue, functionality and quality of life in people with multiple sclerosis. A randomized clinical trial. J Neuroeng Rehabil. 2024 Mar 2;21(1):33. doi: 10.1186/s12984-024-01325-w.'}]}, 'descriptionModule': {'briefSummary': 'This randomised clinical trial investigates the effects of powerball using static and dynamic surface on upper limb Endurance and coordination in children with Down Syndrome. The study involves 28 children with Down Syndrome aged 6-10 years, will be randomly assigned one of the two groups for 3 week intervention period.\n\nPower ball training 3 sessions per week with the duration of 30 mins each session. Group A will receive different upper extremity activities with power ball on static surface while Group B will receive same activities with power ball on dynamic surface using a BOSU ball. The whole session followed by warm up and cool down sessions for 5 minutes each. Endurance will be assessed through ABIL-HAND kids tool. To access the coordination BOT-2 subsets test will be used.\n\nData will be assessed using SPSS 27.0.', 'detailedDescription': 'This Randomized Clinical Trial (RCT) investigates the Comparative Effects of Powerball using static and dynamic surface on Upper Limb Endurance and Coordination in Children with Down Syndrome.This programme was designed to enhance the coordination and endurance in children with Down Syndrome.The efficacy of this programme was investigated through RCT. Data will be collected from special schools or rehabilitation centers. Data will be conducted on 28 children aged 6-10 years,diagnosed with Down Syndrome with reduced upper extremity endurance and coordination..\n\nAfter screening participants will undergo 3 weeks power ball endurance training session, consisting of structured, repetitive and goal directed activities. Power ball training 3 sessions per week with the duration of 30 mins each session. Group A will receive different upper extremity activities with power ball on static surface while Group B will receive same activities with power ball on dynamic surface using a BOSU ball. The whole session followed by warm up and cool down sessions for 5 minutes each. Endurance will be assessed through ABIL-HAND kids tool. To access the coordination BOT-2 subsets test will be used.\n\nData will be assessed using SPSS 27.0.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with Down Syndrome\n\n * Aged between 6-10 years\n * Both Genders\n * Ability to follow commands and instructions\n\nExclusion Criteria:\n\n* Children with any orthopedic and neurological conditions associated with the syndrome • Children with any other Genetic disorder.'}, 'identificationModule': {'nctId': 'NCT07244133', 'briefTitle': 'Effects of Powerball in Children With Down Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Comparative Effects Of Powerball Using Static and Dynamic Surface on Upper Limb Endurance and Coordination in Children With Down Syndrome', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/Aymun Javed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The intervention will be power ball exercises on static surface', 'description': 'Participants will undergo 3 weeks power ball endurance training session, consisting of structured, repetitive and goal directed activities. Power ball training 3 sessions per week with the duration of 30 mins each session. Group A will receive different upper extremity activities with power ball on static surface.The whole session followed by warm up and cool down sessions for 5 minutes each.Endurance will be assessed through ABIL-HAND kids tool. To access the coordination BOT-2 subsets test will be used.\n\nData will be assessed using SPSS 27.0.', 'interventionNames': ['Other: Power ball with static surface']}, {'type': 'EXPERIMENTAL', 'label': 'The intervention will be powerball exercises on dynamic surface', 'description': 'Participants will undergo 3 weeks power ball endurance training session, consisting of structured, repetitive and goal directed activities. Power ball training 3 sessions per week with the duration of 30 mins each session. Group B will receive different upper extremity activities with power ball on dynamic surface.The whole session followed by warm up and cool down sessions for 5 minutes each. Endurance will be assessed through ABIL-HAND kids tool. To access the coordination BOT-2 subsets test will be used.\n\nData will be assessed using SPSS 27.0.', 'interventionNames': ['Other: Powerball with dynamic surface']}], 'interventions': [{'name': 'Power ball with static surface', 'type': 'OTHER', 'description': 'Participants will undergo 3 weeks power ball endurance training session, consisting of structured, repetitive and goal directed activities. Power ball training 3 sessions per week with the duration of 30 mins each session. Group A will receive different upper extremity activities with power ball on static surface. The whole session followed by warm up and cool down sessions for 5 minutes each.', 'armGroupLabels': ['The intervention will be power ball exercises on static surface']}, {'name': 'Powerball with dynamic surface', 'type': 'OTHER', 'description': 'Participants will undergo 3 weeks power ball endurance training session, consisting of structured, repetitive and goal directed activities. Power ball training 3 sessions per week with the duration of 30 mins each session.Group B will receive same activities with power ball on dynamic surface using a BOSU ball. The whole session followed by warm up and cool down sessions for 5 minutes each.', 'armGroupLabels': ['The intervention will be powerball exercises on dynamic surface']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5400', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Muhmmad Asif Javed, MS', 'role': 'CONTACT', 'email': 'a.javed@ripah.edu.pk', 'phone': '033224209422'}, {'name': 'Aymun Javed, MS*', 'role': 'CONTACT', 'email': 'aymunbutt02@gmail.com', 'phone': '03216423117'}], 'facility': 'Imran Amjad', '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, MSPT', 'role': 'CONTACT', 'email': 'a.javed@riphah.edu.pk', 'phone': '923224209422'}], 'overallOfficials': [{'name': 'AYMUN JAVED, MSPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ripha International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}