Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT04430504
Status:
UNKNOWN
Last Update Posted:
2020-11-17
First Post:
2020-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Case series of eligible patients'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2020-05-29', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Goal Attainment Scaling', 'timeFrame': '20 weeks', 'description': 'Outcome scaling: -2 (worse expected outcome), -1 (less than expected outcome), 0 (expected outcome), +1 (more than expected outcome), +2 (best expected outcome)'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory', 'timeFrame': '20 weeks', 'description': '21-question inventory to yield a total score 0-63: 0-13 (no depression), 14-19 (mild depression), 20-28 (moderate depression), 29-63 (severe depression)'}, {'measure': 'WHOQOL-Bref', 'timeFrame': '20 weeks', 'description': '26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items). Each domain scoring 0-100 (0 = worst, 100= best possible) to compare with age-related mean values.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telerehabilitation', 'Case series', 'Traumatic brain injury'], 'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the outcome of a multidiscplinary telerehabilitation after traumatic brain injury assessed by the patient and the therapists with respect to the overall feasibility of the therapy protocol and the effects on psychological well-being and quality of life..', 'detailedDescription': 'Patients from 18 to 60 years of age recovering after traumatic brain injury are recruited to participate in a multidisciplinary telerehabilitation containing total of 20 video meetings over a period of 4-5 months. The study design consists of a 3-day visit in rehabilitation ward for the pre-treatment clinical assessments and education on the telerehabilitation protocol. A self-exercise program is supervised and monitored using a health platform application on a tablet computer through weekly video meetings. A digital diary recordings enable the therapists to track on the progress of therapies. The primary goal is to achieve the individual goals set in the Goal Attainment Scaling. The secondary goals are related to the improvement of psychological well-being (BDI) and quality of life (WHOQOL-Bref).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sequelae of traumatic brain injury\n* capable of doing self exercises at home and participating in video meetings\n\nExclusion Criteria:\n\n* moderate or severe aphasia\n* poor recovery potential for return to school or working life based on clinical assessment'}, 'identificationModule': {'nctId': 'NCT04430504', 'briefTitle': 'Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Vetrea Terveys Oy'}, 'officialTitle': 'Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'EMoK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation (TR)', 'description': 'Multidisciplinary, weekly video meetings, self-exercises at home, digital diary recordings, follow-up assessments', 'interventionNames': ['Behavioral: multidisciplinary telerehabilitation']}], 'interventions': [{'name': 'multidisciplinary telerehabilitation', 'type': 'BEHAVIORAL', 'description': 'weekly video meetings to instruct and monitor self-exercises at home', 'armGroupLabels': ['Telerehabilitation (TR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70820', 'city': 'Kuopio', 'state': 'Northern Savonia', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Kauko Pitkänen', 'role': 'CONTACT', 'email': 'kauko.pitkanen@vetrea.fi', 'phone': '0505965289'}, {'name': 'Leena Korhonen, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VetreaNeuron', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'centralContacts': [{'name': 'Kauko Pitkänen, MD, PhD', 'role': 'CONTACT', 'email': 'kauko.pitkanen@vetrea.fi', 'phone': '0505965289', 'phoneExt': '358'}], 'overallOfficials': [{'name': 'Kauko Pitkänen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'VetreaNeuron'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vetrea Terveys Oy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}