Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT04383405
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2020-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-07', 'studyFirstSubmitDate': '2020-05-07', 'studyFirstSubmitQcDate': '2020-05-07', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Berg Balance Scale (BBS) at 1month', 'timeFrame': '1 month', 'description': 'Change of Berg Balance Scale (BBS) from baseline at 1 month. BBS values ranging from 0 to 56, where 0 means the lowest level of function and 56 the highest'}], 'secondaryOutcomes': [{'measure': 'Tinetti Balance and Gait Scale (TBG)', 'timeFrame': 'baseline and after 4 weeks of training', 'description': 'Change of Tinetti Balance and Gait Scale (TBG) from baseline at 4 weeks of training and at 4 weeks after the end of the training. TBG values ranging from 0 to 28, where 0 means the worse outcome and 28 the best one.'}, {'measure': 'Modified Barthel Index (MBI)', 'timeFrame': 'baseline and after 4 weeks of training', 'description': 'Change of Modified Barthel Index (MBI) from baseline at 4 weeks of training and at 4 weeks after the end of the training. MBI values ranging from 0 to 105, where 0 means the worse outcome and 105 the best one.'}, {'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': 'baseline and after 4 weeks of training', 'description': 'Change of Modified Ashworth Scale (MAS) from baseline at 4 weeks of the training and at 4 weeks after the end of the training. MAS values ranging from 0 to 5, where 0 means the best outcome and 5 the worse one.'}, {'measure': 'Change in quality of life assessed by the proxy version of the Quality of Life after Brain Injury (Proxy-QOLIBRI)', 'timeFrame': 'baseline and after 4 weeks of training', 'description': 'Change of proxy version of the Quality of Life after Brain Injury (Proxy-QOLIBRI) from baseline at 4 weeks of training and at 4 weeks after the end of the training. (Proxy-QOLIBRI) values ranging from 0 to 100, where 0 means the worse outcome and 100 the best one.'}, {'measure': 'Disability Rating Scale (DRS)', 'timeFrame': 'baseline and after 4 weeks of training', 'description': 'Measure of function after TBI intended to measure function from "coma to community." Minimum score= 0; Maximum score= 29 (High scores are indicative of greater degree of disability).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury', 'Severe Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': "Traumatic brain injury (TBI) is an acquired insult to the brain from an external mechanical force. It is considered a major cause of mortality and of long-term disabilities in young adults, especially considering high-income countries.\n\nThe TBI can cause a wide range of temporary and/or permanent brain's dysfunctions that can involve physical, cognitive, behavioural and emotional functioning limiting everyday life and social activities and leading to a lowers quality of life.\n\na sequential preparatory approach (SPA), performed in aquatic environment, based on increasing difficulty and following a specific sequence of preparatory exercises (from the simplest to the most complex) could be an effective complementary training during post-acute intensive rehabilitation in patients with severe traumatic brain injury (sTBI)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 15 and 65 years;\n* Glasgow coma scale (GCS) score ≤ 8 (used to objectively describe the severity of impaired consciousness at the time of injury)\n* level of cognitive functioning (LCF) ≥7;\n* ability to understand verbal commands.\n* acclimatization to water.\n\nExclusion Criteria:\n\n* Cognitive deficits affecting the ability to understand task instructions (Mini-Mental State Examination \\> 24);\n* Severe unilateral spatial neglect (diagnosed with a test battery that included the Letter Cancellation test, Barrage test, Sentence Reading test and the Wundt-Jastrow Area Illusion Test);\n* Severe aphasia (diagnosed by means of neuropsychological assessment);\n* Presence of other neurological diseases;\n* Presence of cutaneous and mycosis infections;\n* Presence of open wounds, eczema, skin ulcers, decubitus lesions, severe burns;\n* Presence of PEG (Percutaneous endoscopic gastrostomy);\n* Presence of tracheostomy;\n* Urinary incontinence;\n* Presence of otitis\n* Presence of orthopedic or cardiac comorbidities that would limit participation in the experimental and conventional training (all of which were clinically evaluated).'}, 'identificationModule': {'nctId': 'NCT04383405', 'briefTitle': 'Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'I.R.C.C.S. Fondazione Santa Lucia'}, 'officialTitle': 'Aquatic Therapy During Post-acute Intensive Neurorehabilitation in Patients With Severe Traumatic Brain Injury: a Preliminary Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CE/PROG775/2019SPA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequential Preparotory Approach', 'interventionNames': ['Other: Aquatic Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'interventionNames': ['Other: Conventional Training']}], 'interventions': [{'name': 'Aquatic Training', 'type': 'OTHER', 'description': 'Aquatic Training training consists of a sequential and a preparatory approach aimed at enhancing dynamic postural stability. The exercises follow a specific sequence starting from a kneeling position, proceeding to a sitting position and ending with a supine position. Step exercises preparatory for gait were performed using a step and two floating aids. Gait exercises were performed first with the upper limbs placed on two floating aids and then during a dual motor task (i.e. catching a ball thrown by the therapist). Subjects performed three sessions a week for four weeks and each session lasting 45 minutes. The training was carried out by a physiotherapist who had at least 5 years of experience in aquatic neurorehabilitation.', 'armGroupLabels': ['Sequential Preparotory Approach']}, {'name': 'Conventional Training', 'type': 'OTHER', 'description': 'Conventional land-based therapy consists of customized exercises focused on static and dynamic postural stability improvement. The exercises included the active-assisted mobilization, the muscle stretching the postural transition, the balance and the gait training. The control approach was carried out three times a week for four weeks and each session lasted 45 minutes.', 'armGroupLabels': ['Conventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00179', 'city': 'Rome', 'country': 'Italy', 'facility': 'Marco Tramontano', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'I.R.C.C.S. Fondazione Santa Lucia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of rehabilitation Services', 'investigatorFullName': 'Marco Tramontano', 'investigatorAffiliation': 'I.R.C.C.S. Fondazione Santa Lucia'}}}}