Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-27 @ 10:37 PM
Study NCT ID:
NCT06237361
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2024-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilates Benefits in Pediatric Burn Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural 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': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Strength Assessment', 'timeFrame': 'at baseline', 'description': 'Assessed using a calibrated handheld dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA), participants performed three 5-second contractions for each muscle group. The average score in newtons was calculated for each muscle group.'}, {'measure': 'Muscle Strength Assessment', 'timeFrame': 'after 12 weeks', 'description': 'Assessed using a calibrated handheld dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA), participants performed three 5-second contractions for each muscle group. The average score in newtons was calculated for each muscle group.'}, {'measure': '6-minute walk test', 'timeFrame': 'at baseline', 'description': 'Participants were timed and given six minutes to walk as far as they could along a straight course. Running, jumping, or hopping were not allowed.'}, {'measure': '6-minute walk test', 'timeFrame': 'after 12 weeks', 'description': 'Participants were timed and given six minutes to walk as far as they could along a straight course. Running, jumping, or hopping were not allowed.'}], 'secondaryOutcomes': [{'measure': 'Pediatric Quality of Life Inventory', 'timeFrame': 'at baseline', 'description': 'A self-report questionnaire assessing the health-related quality of life (HRQL) of children and adolescents. It includes physical health, psychosocial health, and a total summary score.'}, {'measure': 'Pediatric Quality of Life Inventory', 'timeFrame': 'after 12 weeks', 'description': 'A self-report questionnaire assessing the health-related quality of life (HRQL) of children and adolescents. It includes physical health, psychosocial health, and a total summary score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burns', 'Pilates Exercise', 'Pediatric Burn']}, 'referencesModule': {'references': [{'pmid': '32991508', 'type': 'BACKGROUND', 'citation': 'Aibar-Almazan A, Martinez-Amat A, Cruz-Diaz D, Jesus de la Torre-Cruz M, Jimenez-Garcia JD, Zagalaz-Anula N, Redecillas-Peiro MT, Mendoza-Ladron de Guevara N, Hita-Contreras F. The Influence of Pilates Exercises on Body Composition, Muscle Strength, and Gait Speed in Community-Dwelling Older Women: A Randomized Controlled Trial. J Strength Cond Res. 2022 Aug 1;36(8):2298-2305. doi: 10.1519/JSC.0000000000003790. Epub 2020 Sep 25.'}, {'pmid': '16566563', 'type': 'RESULT', 'citation': 'Farrell RT, Gamelli RL, Sinacore J. Analysis of functional outcomes in patients discharged from an acute burn center. J Burn Care Res. 2006 Mar-Apr;27(2):189-94. doi: 10.1097/01.BCR.0000202615.59734.0E.'}, {'pmid': '31176508', 'type': 'RESULT', 'citation': 'Gojowy D, Kauke M, Ohmann T, Homann HH, Mannil L. Early and late-recorded predictors of health-related quality of life of burn patients on long-term follow-up. Burns. 2019 Sep;45(6):1300-1310. doi: 10.1016/j.burns.2019.03.016. Epub 2019 Jun 5.'}, {'pmid': '41262321', 'type': 'DERIVED', 'citation': 'Azab AR, Basalem N, Alghadier M, Khanam H, George J, Aloraini SM, Alsultan F, Basha MA, S Waked I, Kamel FH. Muscle Strength, Functional Capacity, and Quality of Life Responses to Pilates Exercises in Children with Burn Injuries: A Single-Blinded Randomized Clinical Trial. Iran J Med Sci. 2025 Nov 1;50(11):743-753. doi: 10.30476/ijms.2025.104947.3852. eCollection 2025 Nov.'}]}, 'descriptionModule': {'briefSummary': 'This study investigated the effects of Pilates exercises on lower limb muscle strength, functional capacity, and quality of life in children with burn injuries. In a twelve-week randomized clinical trial involving 60 children, those who received Pilates exercises in addition to traditional physical therapy showed significant improvements in muscle strength, functional capacity, and overall quality of life compared to those who received traditional therapy alone. The findings suggest that incorporating Pilates exercises into rehabilitation programs may enhance outcomes for children recovering from burn injuries.', 'detailedDescription': 'This research focused on examining the impact of Pilates exercises on lower limb muscle strength, functional capacity, and quality of life in children recuperating from burn injuries. The study, conducted as a twelve-week randomized clinical trial with 60 participants, found notable improvements in various aspects for the group receiving Pilates exercises alongside traditional physical therapy. Specifically, enhancements in muscle strength (including hip flexors, extensors, abductors, and more), functional capacity, and overall quality of life scores were statistically significant in the Pilates group compared to those undergoing traditional therapy alone. This suggests a positive influence of Pilates exercises on the rehabilitation of children with lower limb burns.\n\nThe investigation delved into the potential benefits of Pilates exercises, emphasizing their role in augmenting muscle strength, functional capacity, and overall well-being. The study participants, aged 10 to 15 years and recovering from lower limb burns, were randomly assigned to either a control group receiving only traditional physical therapy or a Pilates group combining Pilates exercises with traditional therapy. The outcomes demonstrated significant differences favoring the Pilates group, not only in terms of lower limb muscle strength but also functional capacity, as assessed by the 6-minute walk test, and overall quality of life scores measured through the Pediatric Quality of Life Inventory. The findings suggest that incorporating Pilates into rehabilitation programs for pediatric burn survivors can contribute positively to physical and functional recovery, potentially improving their overall quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren with lower limb (LL) healed burns. Age between 10 and 15 years. Six months post-injury. Mixed deep 2nd \\& 3rd degree burn. Total body surface area (TBSA) between 35-55 percent. Capability to walk securely without assistance.\n\nExclusion Criteria:\n\nLower limb joint range of motion limits. Mental illnesses. Significant behavioral or cognitive impairments. Incapacity to exercise. Metabolic diseases. Neuropathy. Visual or vestibular abnormalities. Medical instability.'}, 'identificationModule': {'nctId': 'NCT06237361', 'briefTitle': 'Pilates Benefits in Pediatric Burn Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Qassim University'}, 'officialTitle': 'Muscle Strength, Functional Capacity and Quality of Life Responses to Pilates Exercises in Children With Burn Injuries', 'orgStudyIdInfo': {'id': 'RHPT/023/014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'traditional physical therapy programs', 'description': 'group that received traditional physical therapy programs (TPTP) alone', 'interventionNames': ['Other: traditional physical therapy program']}, {'type': 'EXPERIMENTAL', 'label': 'Pilates group', 'description': 'received both traditional physical therapy programs and Pilates exercises.', 'interventionNames': ['Other: Pilates exercises', 'Other: traditional physical therapy program']}], 'interventions': [{'name': 'Pilates exercises', 'type': 'OTHER', 'otherNames': ['Pilates band'], 'description': 'participants underwent a 12-week intervention involving three Pilates sessions per week. The Pilates exercises comprised warm-up activities, Pilates routines, and cool-down exercises.', 'armGroupLabels': ['Pilates group']}, {'name': 'traditional physical therapy program', 'type': 'OTHER', 'otherNames': ['Exercise'], 'description': 'The program included a variety of exercises such as range of motion exercises, aerobic exercises, resistance exercises, scar management, occupational therapy, and hand therapy.', 'armGroupLabels': ['Pilates group', 'traditional physical therapy programs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11432', 'city': 'Al Kharj', 'state': 'Riyadh Region', 'country': 'Saudi Arabia', 'facility': 'Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University', 'geoPoint': {'lat': 24.15541, 'lon': 47.33457}}], 'overallOfficials': [{'name': 'Alshimaa Azab, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor, Faculty of Physical Therapy, Cairo University'}, {'name': 'Maged Basha, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qassim 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 are 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': 'Prince Sattam Bin Abdulaziz University', 'class': 'OTHER'}, {'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, College of Medical Rehabilitation, Qassim University', 'investigatorFullName': 'Maged Basha', 'investigatorAffiliation': 'Qassim University'}}}}