Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-02 @ 2:14 AM
Study NCT ID:
NCT03901703
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2019-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Functional Strengthening in Spastic Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2019-04-01', 'studyFirstSubmitQcDate': '2019-04-02', 'lastUpdatePostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pediatric Balance scale', 'timeFrame': 'Change of The Pediatric balance scale at 6 weeks.', 'description': 'The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.'}, {'measure': 'Surface Electromyography (sEMG)', 'timeFrame': 'Change of sEMG data at 6 weeks.', 'description': 'Surface electromyography is a non-invasive procedure involving the detection, recording and interpretation of the electric activity of groups of muscles during activity. The procedure is performed using electrodes placed on the skin surface over the muscles to be tested. sEMG is also used to assess the effects of rehabilitation programs and evaluate muscular function in children with cerebral palsy. Due to its non-invasive properties it is safely and widely used in the pediatric population.'}, {'measure': 'The Six minute walk test', 'timeFrame': 'Change of 6 MWT at 6 weeks.', 'description': 'The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. The test has been shown to be valid and reliable in children with Cerebral Palsy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spastic Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'Functional strengthening exercises have been proven to be effective in patients with spastic cerebral palsy. However, which exercise is the most effective is unknown. The aim of this study is to examine the effectiveness of three different progressive functional exercise programs in children with unilateral and bilateral spastic cerebral palsy.', 'detailedDescription': "Children with Cerebral Palsy have weakness in thier muscles due to cortical lesions leading to deficiencies in motor control, balance and functional abilities. All children with Cerebral Palsy have shown to present with foot and ankle disorders; the ankle dorsi and plantar flexor muscles are both problematic; the plantarflexors are usually spastic and the dorsiflexors are usually not active enough and usually these muscle problems lead to problems in the childrens' gait abilities. When rehabilitation programs are examined, the results of exercises addressing these problems do not have precise answers. Functional strengthening exercises have been proven to be effective in patients with spastic cerebral palsy. However, which exercise is the most effective is unknown. Which muscle goup has the most effect on gait, balance and functional activities is still unclear. Therefore, the investigator's aim in planning this study is to examine the effectiveness of three progressive functional exercise programs in children with unilateral and bilateral spastic cerebral palsy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Accepting to participate in the study,\n* Being between 5-15 years old,\n* Having a diagnosis of Spastic Cerebral Palsy,\n* Being level I-II according to GMFCS,\n\nExclusion Criteria:\n\n* Having limited cooperation which prevents participation in the study,\n* Refusing to participate in the study,\n* Having an orthopedic disorder or systemic illness which prevents movement in the lower extremities,\n* Having a Botulinum toxin application in the last 3 months'}, 'identificationModule': {'nctId': 'NCT03901703', 'briefTitle': 'The Effects of Functional Strengthening in Spastic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'The Effects of Progressive Functional Ankle Strengthening in Children With Unilateral and Bilateral Spastic Cerebral Palsy', 'orgStudyIdInfo': {'id': '465426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dorsiflexor Muscle Strengthening Group', 'description': 'The children in this group will receive functional exercises aiming to strengthen their dorsiflexor muscles alongside standard functional progressive strengthening exercises.', 'interventionNames': ['Other: Physiotherapy and Rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Plantarflexor Muscle Strengthening Group', 'description': 'The children in this group will receive functional exercises aiming to strengthen their plantarflexor muscles alongside standard functional progressive strengthening exercises.', 'interventionNames': ['Other: Physiotherapy and Rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dorsiflexor and Plantarflexor Muscle strengthening Group', 'description': 'The children in this group will receive functional exercises aiming to strengthen both their dorsiflexor and plantarflexor muscles alongside standard functional progressive strengthening exercises.', 'interventionNames': ['Other: Physiotherapy and Rehabilitation']}], 'interventions': [{'name': 'Physiotherapy and Rehabilitation', 'type': 'OTHER', 'description': 'The children in each group will receive 6 weeks of functional strengthening exercises targeting each muscle group according to the arm they are included in.', 'armGroupLabels': ['Dorsiflexor Muscle Strengthening Group', 'Dorsiflexor and Plantarflexor Muscle strengthening Group', 'Plantarflexor Muscle Strengthening Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06500', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Bulent Elbasan, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The exercise protocols and results will be shared with other investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melek Volkan Yazici', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Melek Volkan Yazici', 'investigatorAffiliation': 'Gazi University'}}}}