Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT04740359
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2021-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Trunk Training in Ataxia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020754', 'term': 'Spinocerebellar Ataxias'}, {'id': 'D013132', 'term': 'Spinocerebellar Degenerations'}, {'id': 'D001259', 'term': 'Ataxia'}], 'ancestors': [{'id': 'D002524', 'term': 'Cerebellar Ataxia'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were divided in two groups. Two groups will get two different intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Functional Independence', 'timeFrame': 'through of te study, average 8 weeks', 'description': 'The Functional Independence Scale for Children (WeeFIM) was used determine to independence level.'}, {'measure': 'Trunk impairment', 'timeFrame': 'through of te study, average 8 weeks', 'description': 'The Trunk Disorder Scale (TIS) was used to assess static and dynamic sitting balance and trunk coordination'}, {'measure': 'The severity of ataxia', 'timeFrame': 'through of te study, average 8 weeks', 'description': 'The International Ataxia Rating Scale (ICARS) was used to determine the severity'}, {'measure': 'The quality of life', 'timeFrame': 'through of te study, average 8 weeks', 'description': "The Children's Quality of Life Scale (PedsQL) was used determine to quality of life level."}], 'secondaryOutcomes': [{'measure': 'Upper extremity functional performance', 'timeFrame': 'through of te study, average 8 weeks', 'description': 'The 9-Hole Peg test was used to evaluate upper extremity performance'}, {'measure': 'Functional Reach Test', 'timeFrame': 'through of te study, average 8 weeks', 'description': 'Functional Reach Test was used determine to dynamic trunk balance'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ataxia,rehabilitation,trunk,disabilities'], 'conditions': ['Ataxia, Spinocerebellar', 'Ataxias, Hereditary']}, 'referencesModule': {'references': [{'pmid': '20649489', 'type': 'BACKGROUND', 'citation': 'Freund JE, Stetts DM. Use of trunk stabilization and locomotor training in an adult with cerebellar ataxia: a single system design. Physiother Theory Pract. 2010 Oct;26(7):447-58. doi: 10.3109/09593980903532234.'}, {'pmid': '15838852', 'type': 'BACKGROUND', 'citation': 'Van de Warrenburg BP, Bakker M, Kremer BP, Bloem BR, Allum JH. Trunk sway in patients with spinocerebellar ataxia. Mov Disord. 2005 Aug;20(8):1006-13. doi: 10.1002/mds.20486.'}, {'pmid': '19823893', 'type': 'BACKGROUND', 'citation': 'Corben LA, Tai G, Wilson C, Collins V, Churchyard AJ, Delatycki MB. A comparison of three measures of upper limb function in Friedreich ataxia. J Neurol. 2010 Apr;257(4):518-23. doi: 10.1007/s00415-009-5352-7. Epub 2009 Oct 13.'}, {'pmid': '27372366', 'type': 'BACKGROUND', 'citation': 'Freund JE, Stetts DM, Vallabhajosula S. Relationships between trunk performance, gait and postural control in persons with multiple sclerosis. NeuroRehabilitation. 2016 Jun 30;39(2):305-17. doi: 10.3233/NRE-161362.'}]}, 'descriptionModule': {'briefSummary': 'The study is to examine the effect of functional trunk training on trunk control and upper extremity functions in patients with autosomal recessive ataxia.', 'detailedDescription': "Hereditary ataxias are a group of genetic diseases characterized by slow progressive gait disturbance. In addition, coordination disorders can be seen in extremities, speech and eye movements. Atrophy is common in the cerebellum. Friedreich's ataxia, ataxia telangiectasia, ataxia with vitamin E deficiency, infantile-onset spinocerebellar atrophy and Marinesco-Sjögren syndrome are autosomal recessive hereditary ataxias. The constant main sign of autosomal recessive ataxia is progressive ataxia.\n\nThe trunk has an important role on dynamic stabilization for postural reactions and limb movements. A good trunk support enables movements in other parts of the body to occur more regularly. Trunk stabilization is important to support upper and lower extremity movements, to meet the loads, and to protect the spinal cord. The relationship between upper extremity function, daily living activities and trunk functions has been emphasized in many studies but comparative studies about the rehabilitation were very less.\n\nThis study is to evaluate the effect o functional trunk training in patients with autosomal recessive ataxia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Without any communication impairment (seeing, hearing, hearing),\n* Have not had surgery for the upper and lower extremities in the last 6 months,\n* Between the ages of 5 and 18,\n* The mental level determined by the pediatrician is sufficient,\n\nExclusion Criteria:\n\n* Patients who want to leave the study at any stage of the study\n* Patients who do not attend regular training'}, 'identificationModule': {'nctId': 'NCT04740359', 'briefTitle': 'Functional Trunk Training in Ataxia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hasan Kalyoncu University'}, 'officialTitle': 'The Effect of Functional Trunk Training on Trunk Control and Upper Extremity Functions in Hereditary Ataxia Patients With Autosomal Recessive', 'orgStudyIdInfo': {'id': '2020/107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Routine training; mat exercises and perturbation training', 'interventionNames': ['Other: Routine training']}, {'type': 'EXPERIMENTAL', 'label': 'Study', 'description': 'Trunk training; Functional training, mat exercises and perturbation training', 'interventionNames': ['Other: Functional training']}], 'interventions': [{'name': 'Functional training', 'type': 'OTHER', 'description': 'The therapy program was planned for 8 weeks and the sessions were performed in 45 minutes (min) for 3 days a week. The functional reach (forward-lateral-cross), trunk rotation exercises were performed in the sitting positions.(25min) Facilitation of trunk extension and elongation in the prone position (10 min). Thoracic mobilization on exercise ball (10min).', 'armGroupLabels': ['Study']}, {'name': 'Routine training', 'type': 'OTHER', 'description': 'The therapy program was planned for 8 weeks and the sessions were performed in 45 minutes (min) for 3 days a week. The strengthening exercises were applied on the mat (3x10 for the first 4 weeks and 3x15 repetition for the last 4 weeks). Eyes open-closed perturbation training was performed for trunk control in sitting and standing positions (10 min.).', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Gaziantep', 'state': 'Eyalet/Yerleşke', 'country': 'Turkey (Türkiye)', 'facility': 'Hasan kalyoncu üniversitesi', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasan Kalyoncu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Res Asst', 'investigatorFullName': 'Sedat Yiğit', 'investigatorAffiliation': 'Hasan Kalyoncu University'}}}}