Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-29 @ 9:35 AM
Study NCT ID:
NCT04329793
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2020-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With 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'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-02', 'studyFirstSubmitDate': '2020-03-07', 'studyFirstSubmitQcDate': '2020-03-31', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability and quality of walking.', 'timeFrame': 'Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention', 'description': 'Changes in Gross Motor Function Measure-88 (dimensions IV y V)'}], 'secondaryOutcomes': [{'measure': 'Functionality and autonomy', 'timeFrame': 'Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention', 'description': 'Differences in the basic activities of daily life, measured with the PedsQL- Cerebral Palsy Module'}, {'measure': 'Muscle strength', 'timeFrame': 'Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention', 'description': 'Differences in muscle strength of lower limbs, measured with dynamometer.'}, {'measure': 'Range of motion', 'timeFrame': 'Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention', 'description': 'Analyze if the range of joint mobility is increased in those joints that are more limited, measured with goniometer.'}, {'measure': 'Spasticity', 'timeFrame': 'Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention', 'description': 'Changes in spasticity values, measured with the modified Ashworth Scale. Higher scores mean worse outcome. Minimum value is 0. Maximum value is 4.'}, {'measure': 'Quality of walking: Edinburgh Visual Gait Scale', 'timeFrame': 'Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention', 'description': 'Changes in Edinburgh Visual Gait Scale values. Higher scores mean worse outcome. Minimum value is 0. Maximum value is 34.'}, {'measure': 'Gait endurance', 'timeFrame': 'Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention', 'description': 'Changes in 6 minutes walk test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '39009990', 'type': 'DERIVED', 'citation': 'Olmos-Gomez R, Calvo-Munoz I, Gomez-Conesa A. Treatment with robot-assisted gait trainer Walkbot along with physiotherapy vs. isolated physiotherapy in children and adolescents with cerebral palsy. Experimental study. BMC Neurol. 2024 Jul 15;24(1):245. doi: 10.1186/s12883-024-03750-9.'}]}, 'descriptionModule': {'briefSummary': "The improvement of walking capacity is a key objective of the rehabilitation of children with PC. There are different approaches from physiotherapy to address this need, including walking on the ground and on treadmill with partial weight support. Currently, there are robotic technologies adapted to the functional rehabilitation of patients. Assisted gait training with robotic devices such as the Walkbot allows a longer duration of training, at more variable speeds, and with a constant gait pattern adapted to the patient. This training, based on the intensity and repetition of the movement, has beneficial effects on the recovery and improvement of the patient's postural and locomotor functions.\n\nThere are some studies that evaluate walking interventions on treadmill with partial weight support, on the ground and in assisted walking robot in patients with PC.\n\nCurrently, there are no studies conducted that report the effectiveness of interventions performed with robotic walking training device Walkbot K on PC. However, studies in adults with Walkbot S, affected with neurological injury, have reported good results.\n\nAssisted gait training with robotic devices such as the Walkbot, based on the intensity and repetition of the movement, has beneficial effects on the recovery and improvement of the patient's postural and locomotor functions. However, due to the little evidence that exists, it is necessary to know the effectiveness of the Walkbot assisted walking robot in these patients by means of a clinical trial that allows to firmly establish the scope of its benefits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cerebral palsy diagnosis (diplegia or tetraplegia)\n* Ability to communicate even if not verbal (yes/not; gestures; pictograms; sounds)\n* Levels II, III and IV in GMFCS\n* Unsupported seating capacity\n* Go on standing with or without help\n* Not receiving therapy with a walking robot and not having received it in at least one year\n\nExclusion Criteria:\n\n* Serious psychiatric problems\n* Serious heart problems\n* Active tumors\n* Severe joint degenerative problems\n* Degenerative diseases of the nervous system\n* Mitochondrial diseases\n* Recent surgeries\n* Unbound fractures\n* Severe osteoporosis\n* Uncontrolled seizures\n* Open wounds in the lower half of the body\n* Extreme fear of being placed in robotic devices\n* Anthropomorphic measures are below the minimum required to use the device'}, 'identificationModule': {'nctId': 'NCT04329793', 'briefTitle': 'Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Murcia'}, 'officialTitle': 'Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With Cerebral Palsy', 'orgStudyIdInfo': {'id': '2365/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Assisted gait training with Walkbot System and their usual Physical Therapy.', 'interventionNames': ['Device: Assisted gait training with Walkbot System', 'Other: Physical Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': 'Their usual Physical Therapy.', 'interventionNames': ['Other: Physical Therapy']}], 'interventions': [{'name': 'Assisted gait training with Walkbot System', 'type': 'DEVICE', 'otherNames': ['Physical Therapy'], 'description': 'The experimental group will receive at least 3 treatment sessions per week consisting of 40 minutes in robot-assisted gait training with Walkbot System in addition to their usual Physical therapy sessions. In total, the number of Walkbot sessions will be 20, in uninterrupted weeks.', 'armGroupLabels': ['Intervention arm']}, {'name': 'Physical Therapy', 'type': 'OTHER', 'description': 'The control group will receive their usual Physical therapy sessions during 6 weeks.', 'armGroupLabels': ['Control arm', 'Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30510', 'city': 'Yecla', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Raquel Olmos Gómez', 'geoPoint': {'lat': 38.61365, 'lon': -1.11468}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Raquel Olmos Gómez', 'investigatorAffiliation': 'Universidad de Murcia'}}}}