Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2026-01-22 @ 11:21 PM
Study NCT ID:
NCT04486703
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2020-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-24', 'studyFirstSubmitDate': '2020-07-22', 'studyFirstSubmitQcDate': '2020-07-23', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain in the lower limb', 'timeFrame': '12 weeks', 'description': 'Visual analogue scale for pain assessment ,zero indicates no pain ten indicates maximum pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lower Limb Burn']}, 'descriptionModule': {'briefSummary': 'The purpose of the current study was to evaluate the effect of physical therapy rehabilitation program combined with music therapy on pediatric with lower limb burn. Methods. A twelve-week randomized controlled study including thirty lower limb pediatric burned patients who randomly divided into two groups, Group(A) received physical therapy rehabilitation program combined with music therapy in addition to routine medical care while Group (B) received physical therapy rehabilitation program without music therapy. Pain was assessed by visual analogue scale (VAS) and range of motion (ROM) was assessed by goniometer, and gait assessed by GAIT Rite. Assessment was carried before and after treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lower limb 2nd degree burn since 6 weeks\n* Burn affect skin around ankle and knee joint,\n* Both sex, age ranged between 10 to 15 years old\n* Patients have sufficient cognition and education enough to understand the requirements of this study\n\nExclusion Criteria:\n\n* All patients with age more than 15 years or less than 10 years\n* Patients with hearing problems\n* Acute viral diseases, acute tuberculosis, mental disorders\n* Those with pace makers, diabetics, cardiac, renal patients\n* Patients with genetic disease\n* 3rd degree burn and 1st degree bum'}, 'identificationModule': {'nctId': 'NCT04486703', 'briefTitle': 'Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn: a Twelve-week Randomized Controlled Study', 'orgStudyIdInfo': {'id': '6m8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise with music group', 'description': 'physical therapy program combined with music therapy', 'interventionNames': ['Other: Exercise with music']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'physical therapy program without music', 'interventionNames': ['Other: Exercise with music']}], 'interventions': [{'name': 'Exercise with music', 'type': 'OTHER', 'description': 'physical therapy program combined with music therapy 15 min, 3 times weekly for 12 weeks.', 'armGroupLabels': ['Exercise group', 'Exercise with music group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2011', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Marwa Eid', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor of physical therapy for surgery', 'investigatorFullName': 'Marwa Eid', 'investigatorAffiliation': 'Cairo University'}}}}