Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-25 @ 2:41 AM
Study NCT ID:
NCT05251935
Status:
COMPLETED
Last Update Posted:
2022-02-23
First Post:
2022-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Down Syndrome and Effects of Foot Muscle Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009123', 'term': 'Muscle Hypotonia'}, {'id': 'D005413', 'term': 'Flatfoot'}, {'id': 'D007593', 'term': 'Joint Instability'}], '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'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000070558', 'term': 'Talipes'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005532', 'term': 'Foot Deformities, Congenital'}, {'id': 'D038061', 'term': 'Lower Extremity Deformities, Congenital'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-12', 'studyFirstSubmitDate': '2022-02-12', 'studyFirstSubmitQcDate': '2022-02-12', 'lastUpdatePostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gross Motor Function', 'timeFrame': 'Baseline', 'description': 'Gross Motor Function was assessed using GMFM-88 Dimensions D and E'}, {'measure': 'Gross Motor Function', 'timeFrame': '12 weeks', 'description': 'Gross Motor Function was assessed using GMFM-88 Dimensions D and E'}, {'measure': 'Gross Motor Function', 'timeFrame': '24 weeks', 'description': 'Gross Motor Function was assessed using GMFM-88 Dimensions D and E'}, {'measure': 'Balance', 'timeFrame': 'Baseline', 'description': 'Balance was assessed using Pediatric Balance Scale'}, {'measure': 'Balance', 'timeFrame': '12 weeks', 'description': 'Balance was assessed using Pediatric Balance Scale'}, {'measure': 'Balance', 'timeFrame': '24 weeks', 'description': 'Balance was assessed using Pediatric Balance Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Down syndrome', 'foot deformities', 'muscle hypotonia', 'pes planus', 'joint laxity', 'exercise training'], 'conditions': ['Pes Planus Down Syndrome Patients']}, 'descriptionModule': {'briefSummary': 'Down syndrome (DS) is a common chromosomal pediatric disorder and accounts for approximately 8 % of all congenital anomalies. Children with DS experience delays in Cognitive, Physical, Speech and Language development. Hypotonity and laxity that is part of its features causes delay on motor acquisition. Furthermore it causes musculoskeletal issues and lower extremity malalignment resulting in inefficient and abnormal pattern of movement compromising locomotion and day to day functions therefore, problems for the population further aggravates. Combined effects of these factors causes a high level of stress on foot as it provides the foundation for whole body therefore, individuals with Down syndrome are at risk for foot alignment problems. Pes planus being the most common amongst them and accounts for 91% of the total DS patients diagnosed. Pes planus causes alteration in foot kinetics and kinematics that not only interferes significantly with normal daily life activities as balance and gait but also increases the risk of musculoskeletal injuries. Hence researchers have shown interest in addressing this condition for the effective management of DS population. Conventional treatment approach are the use of insoles, foot orthosis and arch taping however, they fail to produce residual effect. Hence the present study is to determine the role of foot muscles exercises in Down Syndrome having pes planus since its effects are positively recorded in normal population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Clinically diagnosed cases of DS including both male and female.\n\n * Bilateral flexible pes planus on the basis of Navicular Drop Test.\n * Able to follow instructions and adhere to the exercise program.\n * Ambulating independently.\n\nExclusion Criteria:\n\n* • Visual or auditory impairment.\n\n * Lower limb trauma or surgical intervention past six months.'}, 'identificationModule': {'nctId': 'NCT05251935', 'briefTitle': 'Down Syndrome and Effects of Foot Muscle Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Ziauddin University'}, 'officialTitle': 'Effects of Foot Muscle Exercise on Gross Motor Function and Balance Among Pes Planus Down Syndrome Patients', 'orgStudyIdInfo': {'id': 'Nazia Adeeb'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Foot Muscle Exercise', 'interventionNames': ['Other: Foot Muscle Exercise Protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arch Support Insole and One Leg Balance Activities', 'interventionNames': ['Combination Product: Arch Support Insole and One Leg Balance Activities']}], 'interventions': [{'name': 'Foot Muscle Exercise Protocol', 'type': 'OTHER', 'description': 'Foot Muscle Exercise was given for 3 days per week for 40 minutes for the period of 6 months including home program', 'armGroupLabels': ['Foot Muscle Exercise']}, {'name': 'Arch Support Insole and One Leg Balance Activities', 'type': 'COMBINATION_PRODUCT', 'description': 'Arch Support Insoles were provided that the child had to wear for 5 hours per day thrice weekly for 6 months plus performed one leg balance activities', 'armGroupLabels': ['Arch Support Insole and One Leg Balance Activities']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75530', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'ACELP (Institute of Child Development)', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziauddin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department', 'investigatorFullName': 'Nazia Adeeb', 'investigatorAffiliation': 'Ziauddin University'}}}}