Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-03-01 @ 3:54 PM
Study NCT ID:
NCT03268304
Status:
WITHDRAWN
Last Update Posted:
2020-04-21
First Post:
2017-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Two New Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D020275', 'term': 'Guillain-Barre Syndrome'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The software modules were not completed.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-17', 'studyFirstSubmitDate': '2017-08-29', 'studyFirstSubmitQcDate': '2017-08-30', 'lastUpdatePostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cARAT', 'timeFrame': '17 weeks', 'description': 'Score on the conventional Action Research Arm Test'}, {'measure': 'dARAT', 'timeFrame': '17 weeks', 'description': 'score on the digital ARAT'}, {'measure': 'SUS', 'timeFrame': '15 weeks', 'description': 'System Usability Scale questionnaire'}], 'secondaryOutcomes': [{'measure': 'BBT', 'timeFrame': '17 weeks', 'description': 'Box and Block Test'}, {'measure': 'CAHAI', 'timeFrame': '17 weeks', 'description': 'Chedoke McMaster Arm and Hand Activity Inventory'}, {'measure': 'EQ-5D-5L', 'timeFrame': '17 weeks', 'description': 'EuroQol five dimensions questionnaire with five-level scale'}, {'measure': 'PGIC', 'timeFrame': '11 weeks', 'description': 'Patient Global Impression of change'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Upper Limb Motor Function Deficit', 'Neurorehabilitation', 'Virtual Reality', 'Action Research Arm Test'], 'conditions': ['Stroke', 'Parkinson Disease', 'Traumatic Brain Injury', 'Guillain-Barre Syndrome']}, 'referencesModule': {'references': [{'pmid': '30012780', 'type': 'DERIVED', 'citation': 'Behrendt F, Schuster-Amft C. Using an interactive virtual environment to integrate a digital Action Research Arm Test, motor imagery and action observation to assess and improve upper limb motor function in patients with neuromuscular impairments: a usability and feasibility study protocol. BMJ Open. 2018 Jul 16;8(7):e019646. doi: 10.1136/bmjopen-2017-019646.'}]}, 'descriptionModule': {'briefSummary': "Introduction: In the recent past, medical training systems using virtual reality (VR) have been introduced to neurorehabilitation to train motor function deficits in patients. The usage of VR-based training systems is based on the evidence of neuroplasticity, which is responsible for recovery of patients suffering from motor dysfunction. Such systems are increasingly used to encourage purposeful limb movements in a VR environment and its efficacy has been found comparable with conventional therapeutic intervention. VR training systems, e.g. the YouGrabber® (YG), will increasingly also be used at home. Therefore, it is essential to integrate valid and reliable assessment tools to monitor the recovery process.\n\nObjectives: The aim of the clinical study is to evaluate the usability, feasibility and validity of the digital version of the ActionResearchArmTest (d-ARAT) using the YG system as a platform. Additionally, the feasibility and usability of the implementation of two rehabilitation measures that only recently became integral part of neurorehabilitation, e.g. Action Observation (AO) and Motor Imagery (MI), into the YG training software will be evaluated. Patients \\& methods: This observational study is designed as a single-arm trial for testing the assessment software including pre- to post rehabilitation comparison of a training involving AO and MI. Therefore, 75 adult patients with Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barré syndrome will be included. 30 out of the 75 patients will take part in the 4-week training on the enhanced VR-based system with a total of 16 training sessions of 45 min each. Primary outcomes will be the score on the System Usability Scale (SUS) and the ARAT as well as the d-ARAT scores. Secondary outcomes will be hand dexterity (Box-and-Block Test), upper limb activities of daily living (CAHAI) and quality of life (EQ-5D-5L).\n\nHypothesis: The study was designed to evaluate the d-ARAT and the training software modules for the YG system. Currently AO and MI specific tasks are being integrated and the ARAT subscales will be implemented on the basis of the redesigned glove equipped with new sensors. The results are expected to give recommendations for necessary modifications. They might also contribute knowledge concerning the application of AO and MI tasks within VR training."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "1. Patients will be recruited from the clinics' inpatient or outpatient departments by physicians, therapists and nurses.\n2. Patients will be recruited from the clinics' patient database. Datasets will be screened for study selection criteria by the involved study personnel. If patients are eligible, they will be sent a letter describing the study and including patient information. If patients are interested in participating, they can contact the study personnel in the clinic by phone or email.\n3. Patients will be recruited via a study information flyer provided on the clinic's homepage and through patient self-help groups. If patients are interested in participating, they can contact the study personnel in the responsible clinic by phone or email.", 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with motor function impairments of one or both upper limbs caused by Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barré syndrome\n* Able to sit in a normal chair without armrests\n* Able to score at least one in the Box and Block Test (BBT)\n* Comprehend German\n* Informed Consent as documented by signature\n\nExclusion Criteria:\n\n* Wrist-, hand- or finger contractures or an unconsolidated upper limb fracture\n* Severe cognitive deficits: Mini-Mental-Status-Test (MMSE) ≤ 20\n* Severe spatial-visual disorders, e.g. severe visual neglect\n* History of epileptic seizures triggered by visual stimuli (e.g. television, video games) within the last six months\n* Enrolment of the investigator, his/her family members, employees and other dependent persons\n* Full score in the Chedoke Arm and Hand Activity Inventory (CAHAI) assessment\n* Brain pacemaker"}, 'identificationModule': {'nctId': 'NCT03268304', 'briefTitle': 'Feasibility of Two New Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments', 'organization': {'class': 'OTHER', 'fullName': 'Reha Rheinfelden'}, 'officialTitle': 'Feasibility of Two Novel Interactive Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments Using the YouGrabber Training System - the KAYO Study Protocol', 'orgStudyIdInfo': {'id': 'KAYO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'VR-based training including AO and MI', 'type': 'OTHER', 'description': 'Virtual Reality-based training intervention including Action Observation and Motor Imagery using the YouGrabber® training device'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Frank Behrendt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reha Rheinfelden'}, {'name': 'Corina Schuster, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reha Rheinfelden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reha Rheinfelden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Frank Behrendt', 'investigatorAffiliation': 'Reha Rheinfelden'}}}}