Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-28 @ 7:21 PM
Study NCT ID:
NCT04328857
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2020-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2020-02-27', 'studyFirstSubmitQcDate': '2020-03-30', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Joint Stiffness of affected upper limb joint', 'timeFrame': 'After 4 weeks of treatment', 'description': 'Quantitative measure performed by means of an isokinetic machine (Unit of measure: Nm/°). Changes in joint stiffness following the use of new customized devices during a rehabilitation treatment period. Lower stiffness is better.'}], 'secondaryOutcomes': [{'measure': 'Modified Ashworth Scale', 'timeFrame': 'After 4 weeks of treatment', 'description': 'Clinical scale for spasticity (5 levels), higher is worse.'}, {'measure': 'Melbourne Upper Limb Assessment 2', 'timeFrame': 'After 4 weeks of treatment', 'description': 'Clinical scale for evaluating quality of upper limb movement (16 items, each assessed from 0 to 4 points). Result reported in %. Higher is better.'}, {'measure': 'Quality of Upper Extremity Skills Test', 'timeFrame': 'After 4 weeks of treatment', 'description': 'Clinical scale evaluating the quality of upper extremity function (33 items, 4 domains). Minimum score 0, maximum score 100. Higher is better.'}, {'measure': 'Active range of motion', 'timeFrame': 'After 4 weeks of treatment', 'description': 'Measured with goniometer in degrees.'}, {'measure': 'Passive range of motion', 'timeFrame': 'After 4 weeks of treatment', 'description': 'Measured with goniometer in degrees.'}, {'measure': 'Range of motion of target joint during a pointing-forward task', 'timeFrame': 'After 4 weeks of treatment', 'description': 'Measured in degrees. A kinematic analysis will be performed during a pointing-forward task using an optoelectronic system.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acquired Brain Injury']}, 'descriptionModule': {'briefSummary': 'The proposed clinical investigation plan is a pivotal controlled study with two parallel groups, has a total duration of 12 months and involves the recruitment of 34 pediatric patients suffering from acquired brain injury.\n\nThe primary objective of the clinical study is to evaluate the improvement of joint stiffness through the use of sensorized pseudoelastic orthoses for the rehabilitation of pediatric patients with acquired brain injury.\n\nThe effectiveness of the treatment in terms of joint stiffness (primary outcome) will be assessed and the effect of the treatment will be quantified with clinical evaluation scales and instrumental measurements by means of an optoelectronic system and isokinetic machine. The tolerability and acceptability of the device will also be checked.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Quadriplegia or acquired hemiplegia.\n2. Age 6-20 years.\n3. Dystonic, dyskinetic, spastic.\n4. Chronic phase patients (\\> 1 year post event).\n5. Spastic syndrome with Ashworth Score (AS) for the limb of interest\\> 1.\n6. Collaborative.\n\nExclusion Criteria:\n\n1. Fixed limitations of the joint.\n2. Joint pain.\n3. Skin allergies.\n4. Behavioral and psychiatric disorders (eg, emotional problems, anxiety, panic attacks).'}, 'identificationModule': {'nctId': 'NCT04328857', 'briefTitle': 'Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Eugenio Medea'}, 'officialTitle': 'Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing', 'orgStudyIdInfo': {'id': '686'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Upper limb rehabilitation with pseudoelastic orthosis', 'interventionNames': ['Device: pseudoelastic orthosis']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Upper limb rehabilitation without pseudoelastic orthosis'}], 'interventions': [{'name': 'pseudoelastic orthosis', 'type': 'DEVICE', 'description': 'The subject will be given specific physiotherapy including activities oriented to multimodal exploration and refinement of gross and fine motor skills, customized according to the functional status of the individual patient.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23842', 'city': 'Bosisio Parini', 'state': 'LC', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elena Beretta, MD', 'role': 'CONTACT', 'email': 'elena.beretta@lanostrafamiglia.it', 'phone': '+39031877111'}, {'name': 'Fabio A Storm', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'IRCCS Eugenio Medea', 'geoPoint': {'lat': 45.80075, 'lon': 9.29}}], 'centralContacts': [{'name': 'Elena Beretta', 'role': 'CONTACT', 'email': 'elena.beretta@lanostrafamiglia.it', 'phone': '031877851'}, {'name': 'FAbio A Storm', 'role': 'CONTACT', 'email': 'fabio.storm@lanostrafamiglia.it'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Eugenio Medea', 'class': 'OTHER'}, 'collaborators': [{'name': 'CNR - ICMATE UOS di Lecco', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}