Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT04966403
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2021-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Stretch-shortening Cycle Exercises Postural Control in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010809', 'term': 'Physical Fitness'}, {'id': 'D004856', 'term': 'Postural Balance'}], 'ancestors': [{'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006262', 'term': 'Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D011434', 'term': 'Proprioception'}, {'id': 'D000084323', 'term': 'Vestibulocochlear Physiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-08', 'studyFirstSubmitDate': '2021-07-14', 'studyFirstSubmitQcDate': '2021-07-14', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grade of Muscle strength by hand-held dynamometer', 'timeFrame': 'at baseline', 'description': 'A calibrated hand-held dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA) was used'}, {'measure': 'Grade of Muscle strength by hand-held dynamometer', 'timeFrame': 'after 12 weeks', 'description': 'A calibrated hand-held dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA) was used'}], 'secondaryOutcomes': [{'measure': 'Postural control index by Balance Biodex System', 'timeFrame': 'at baseline', 'description': 'Postural stability indices were assessed through the Balance Biodex System (Biodex Medical Systems, Shirley, NY),'}, {'measure': 'Postural control index by Balance Biodex System', 'timeFrame': 'after 12 weeks', 'description': 'Postural stability indices were assessed through the Balance Biodex System (Biodex Medical Systems, Shirley, NY),'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Down Syndrome']}, 'referencesModule': {'references': [{'pmid': '31301057', 'type': 'BACKGROUND', 'citation': 'Alsakhawi RS, Elshafey MA. Effect of Core Stability Exercises and Treadmill Training on Balance in Children with Down Syndrome: Randomized Controlled Trial. Adv Ther. 2019 Sep;36(9):2364-2373. doi: 10.1007/s12325-019-01024-2. Epub 2019 Jul 12.'}, {'pmid': '27512557', 'type': 'RESULT', 'citation': 'Aalizadeh B, Mohammadzadeh H, Khazani A, Dadras A. Effect of a Trampoline Exercise on the Anthropometric Measures and Motor Performance of Adolescent Students. Int J Prev Med. 2016 Jul 13;7:91. doi: 10.4103/2008-7802.186225. eCollection 2016.'}, {'pmid': '20673078', 'type': 'RESULT', 'citation': 'Champagne D, Dugas C. Improving gross motor function and postural control with hippotherapy in children with Down syndrome: case reports. Physiother Theory Pract. 2010 Nov;26(8):564-71. doi: 10.3109/09593981003623659. Epub 2010 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the effect of a 3-month, trampoline-based stretch-shortening cycle (SSC) exercises on muscle strength and postural control in children with Down syndrome.', 'detailedDescription': 'a variety of physical therapy techniques are being used to improve lower limb muscle strength and postural control in children with Down syndrome including, but not limited to, progressive resistance training, hippotherapy, aquatic therapy, and isokinetic strength training. Stretch-shortening (SSC) exercises-also referred to as plyometric exercises, is a traditional form of resistance training that involves three-phase muscle contraction during dynamic movements (like jumping and hopping), where the muscle moves rapidly through the eccentric, isometric, and concentric phases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 7 and 9 years.\n* able to follow one step motor commands.\n* independent ambulators.\n* not suffering from atlantoaxial joint instability as reported from their medical files.\n\nExclusion Criteria:\n\n* Children with un-corrected cardiac anomalies.\n* Children with un-corrected vision or hearing loss.\n* Children with un-corrected pulmonary disorders.\n* Children with un-corrected neurological signs as epilepsy.\n* Children who had a history of musculoskeletal surgery in the lower extremities through the past year.'}, 'identificationModule': {'nctId': 'NCT04966403', 'briefTitle': 'Effects of Stretch-shortening Cycle Exercises Postural Control in Down Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Qassim University'}, 'officialTitle': 'Distinct Effects of Trampoline-based Stretch-shortening Cycle Exercises on Muscle Strength and Postural Control in Children With Down Syndrome: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '0018/0086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'standard physical therapy', 'description': 'Participants in the standard physical therapy received the standard physical therapy (sPT) program, which was conducted according to the needs of each participant and was generally concerned with building strength, enhancing developmental skills, boosting balance, coordination, and postural control, improving physical fitness, and minimizing the development of the compensatory movement patterns that children with DS are likely to develop.', 'interventionNames': ['Other: Standard physical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'trampoline-based stretch-shortening cycle exercises', 'description': 'In addition to the sPT, the SSC group received 15-minute SSC exercise sessions, twice weekly, with a total of 24 sessions over 12 successive weeks.', 'interventionNames': ['Other: trampoline-based stretch-shortening cycle exercises']}], 'interventions': [{'name': 'Standard physical therapy', 'type': 'OTHER', 'otherNames': ['physical fitness'], 'description': 'building strength, enhancing developmental skills, boosting balance, coordination, and postural control', 'armGroupLabels': ['standard physical therapy']}, {'name': 'trampoline-based stretch-shortening cycle exercises', 'type': 'OTHER', 'otherNames': ['postural control'], 'description': 'muscle strength', 'armGroupLabels': ['trampoline-based stretch-shortening cycle exercises']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Kharj', 'state': 'Riyadh Region', 'country': 'Saudi Arabia', 'facility': 'King Khalid Hospital', 'geoPoint': {'lat': 24.15541, 'lon': 47.33457}}], 'overallOfficials': [{'name': 'Alshimaa Azab, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '6 months after publication', 'ipdSharing': 'YES', 'description': 'The data sets generated during and/or analyzed during the current study is available from the corresponding author on reasonable request.', 'accessCriteria': 'relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qassim University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}, {'name': 'Prince Sattam Bin Abdulaziz University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Assistant Professor, College of Medical Rehabilitation, Qassim University, Saudi Arabia. Consultant Physical Therapist, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt.', 'investigatorFullName': 'Maged Basha', 'investigatorAffiliation': 'Qassim University'}}}}