Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-31 @ 1:40 PM
Study NCT ID:
NCT03879304
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2019-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020388', 'term': 'Muscular Dystrophy, Duchenne'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Twelve participants were randomized to follow a multimodal physiotherapy program for 6 weeks. At the end of this period the participants will be crossed to another intervention without virtual reality glasses. The results will be measured before and after each intervention during the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2019-03-09', 'studyFirstSubmitQcDate': '2019-03-15', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in six meter walking test (6-MWT) score', 'timeFrame': 'Baseline, up to six weeks', 'description': 'Six-meter walking test is a a well-established outcome measure in a variety of diseases. It is accurate, reproducible, simple to administer, and well tolerated. The 6MWT is a robust assessment tool for use in clinical trials given its ability to quantitatively evaluate ambulation in a controlled environment.'}], 'secondaryOutcomes': [{'measure': 'EPInfant', 'timeFrame': 'through study completion, average 6 weeks', 'description': 'Scale of perceived child effort measurement EPInfant. It shows 11 numerical descriptors (0 to 10), 5 verbal descriptors located every 2 levels of intensity, and a set of illustrations that represent a child running at increasing intensities along a scale of bars of incremental height following a exponential type slope from left to right. The higher value represent a worse outcome.'}, {'measure': 'NSAA o North Star Ambulatory Assessment', 'timeFrame': 'Baseline, up to 6 weeks', 'description': "Functional scale for children with DMD. It is expressed in points and evidences the acquisition of functions or the loss of them. Whilst DMD children may generally present with recognizable adaptations to activity due to the underlying progressive muscular weakness, they may modify their activity to achieve functional goals in slightly differing ways. Generally, activities are graded in the following manner:\n\n2 - 'Normal' - no obvious modification of activity\n\n1 - Modified method but achieves goal independent of physical assistance from another 0 - Unable to achieve independently. The better punctuation is 34 point, what mean the higher outcome."}, {'measure': 'MFM o Motor Function Measure', 'timeFrame': 'Baseline, up to 6 weeks', 'description': 'measure motor performance'}, {'measure': 'Kids Screen-52', 'timeFrame': 'Baseline.', 'description': 'quality of life test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality [L01.224.160.875], [L01.296.555]', 'Physical Therapy Modalities [E02.779], [E02.831.535]', 'Respiratory Therapy [E02.880]', 'Dystrophin [D12.776.210.500.250]', 'Becker Muscular Dystrophy [C10.668.491.175.500.300]', 'Resistance training [E02.831.535.483.875]', 'Muscular Stretching Therapy [E02.831.535.483.750]'], 'conditions': ['Muscular Dystrophy, Duchenne and Becker Types']}, 'referencesModule': {'references': [{'pmid': '33289679', 'type': 'BACKGROUND', 'citation': 'Baeza-Barragan MR, Labajos Manzanares MT, Ruiz Vergara C, Casuso-Holgado MJ, Martin-Valero R. The Use of Virtual Reality Technologies in the Treatment of Duchenne Muscular Dystrophy: Systematic Review. JMIR Mhealth Uhealth. 2020 Dec 8;8(12):e21576. doi: 10.2196/21576.'}, {'pmid': '37990809', 'type': 'RESULT', 'citation': 'Baeza-Barragan MR, Labajos Manzanares MT, Amaya-Alvarez MC, Morales Vega F, Rodriguez Ruiz J, Martin-Valero R. Effectiveness of a 5-Week Virtual Reality Telerehabilitation Program for Children With Duchenne and Becker Muscular Dystrophy: Prospective Quasi-Experimental Study. JMIR Serious Games. 2023 Nov 15;11:e48022. doi: 10.2196/48022.'}]}, 'descriptionModule': {'briefSummary': "Duchenne's Muscular Dystrophy and Becker Dystrophy, hereafter DMD and BMD, is a serious and progressive disease that affects 1 in 3,500-6,000 males born alive. Scale 6-minute walking test, is used for determine the inclusion of children with DMD in pharmacological studies. Furthemore, is used to verify a training effectiveness assessing muscular endurance and cardio-respiratory functions. This Research evaluates the feasibility and effectiveness of a multimodal physiotherapist program with virtual reality glasses.", 'detailedDescription': 'In addition a physiotherapy program, virtual reality have a lot of importance advantages for train while motivated the kids.\n\nA cross over study will be applied. In the control time, patient will received a initial evaluation and a final without making the physiotherapy program and without virtual reality glasses. The data will be collected by principal examiner.\n\nIn the intervention time the group will received 10 multimodal physiotherapy sessions, two or one per week, along six weeks. Also they are going to training walking with with virtual games.\n\nMultimodal physiotherapist program describes the exercises to be performed, how long it will take, the number of repetitions and the way to do it with the physiotherapist in zoom session.\n\nAt the end of the multimodal physiotherapy program, variables will be evaluated by the principal examiner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between 4 and 15 years\n* Duchenne and Becker Diagnosis ICD-10 issued by specialist in neurology.\n* Children who can walk 10 m at last 120 seconds.\n* First punctuation of North Start Ambulatory assessment bigger than 20 points.\n\nExclusion Criteria:\n\n* An other Dystrophies.\n* Older than 10 years.\n* Not Physiotherapy. Not walk.\n* Asociated heart disease Sprains, fractures. FC \\>120, Sat O2 \\<89%.'}, 'identificationModule': {'nctId': 'NCT03879304', 'acronym': 'RVDuchenne', 'briefTitle': 'Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaga'}, 'officialTitle': 'Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.', 'orgStudyIdInfo': {'id': 'UMalagaRV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multimodal physiotherapy program with RV', 'description': 'The RV intervention group receives a tele multimodal physiotherapy program with tradicional exercises of physiotherapy like stretching, aerobic, training through videos and gamification with VR glasses.', 'interventionNames': ['Other: multimodal physiotherapy program with RV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional physiotherapy program', 'description': 'Traditional intervention group receives assistance of a program of physiotherapy traditional without virtual reality glasses.', 'interventionNames': ['Other: traditional physiotherapy program']}], 'interventions': [{'name': 'multimodal physiotherapy program with RV', 'type': 'OTHER', 'description': 'Physiotherapy Programm includes: respiratory physiotherapy, stretching, resistance training, aerobic training and adaptation and training with virtual reality glasses and relaxation.', 'armGroupLabels': ['Multimodal physiotherapy program with RV']}, {'name': 'traditional physiotherapy program', 'type': 'OTHER', 'description': 'Multimodal physiotherapy Programm includes: traditional physiotherapy, stretching, massage.', 'armGroupLabels': ['Traditional physiotherapy program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29071', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Universidad de Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'overallOfficials': [{'name': 'Rocío Martín Valero, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Málaga'}, {'name': 'Maria Teresa Labajos Manzanares, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Málaga'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'an average of 2 years'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaga', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rosa Baeza Barragán', 'investigatorAffiliation': 'University of Malaga'}}}}