Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-03-03 @ 2:22 AM
Study NCT ID:
NCT02834533
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2016-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Virtual Reality in MS Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-09-04', 'releaseDate': '2020-08-19'}], 'estimatedResultsFirstSubmitDate': '2020-08-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-15', 'studyFirstSubmitDate': '2016-07-04', 'studyFirstSubmitQcDate': '2016-07-14', 'lastUpdatePostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg Balance Scale', 'timeFrame': 'Up to 14 weeks', 'description': 'BBS is a clinical scale to evaluate balance'}], 'secondaryOutcomes': [{'measure': 'Coping Orientation to Problem Experienced', 'timeFrame': 'Up to 14 weeks', 'description': 'The test is aimed at evaluating how a person deals with a specific problem, with two main coping strategies, i.e. adaptation and avoidance.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lokomat;', 'robotic rehabilitation.', 'Multiple Sclerosis;', 'Virtual reality'], 'conditions': ['Multiple Sclerosis Relapse']}, 'descriptionModule': {'briefSummary': 'Objective: To investigate the role of virtual reality (VR) paired with robotic-assisted gait training (RAGT) compared with RAGT alone in patients with Multiple Sclerosis (MS).\n\nMethod: A Randomized, double-blind, controlled clinical trial was carried out in forty patients with relapsing remitting MS. All patients were randomized into two groups. One group practiced Lokomat without VR (group G1), the other one the Lokomat with VR (G2). Both the groups performed 40-1h-training sessions by Lokomat (for 3 times a week). A skilled-blinded neurologist and psychologist administered clinical and neuropsychological scales. All the clinical tests were performed at the beginning (T0) and at the end (T1) of the rehabilitative program.', 'detailedDescription': 'METHODS The present study is a single-blind randomized trial, conducted according to the Declaration of Helsinki, the guidelines for Good Clinical Practice, and the (CONSORT) Statement guidelines. The study protocol was approved by our Institutional Review Board and Ethics Committee (project number: 24/2013).\n\nOne hundred and fifty consecutive outpatients with relapsing-remitting multiple sclerosis and gait and/or balance disturbance, attending the Laboratory of Robotic Neurorehabilitation of the IRCCS Neurolesi Bonino-Pulejo (Messina, Italy) from January 2015 to January 2016, were invited to participate in the study, and were screened for study eligibility.\n\nInclusion/exclusion criteria Inclusion criteria were: age 30-65 years; severe walking disability with Expanded Disability Status Score between 3.5 and 6.0 (Piramidal subitem ≥3); Montreal Cognitive Assessment score ≥24; absence of concomitant neurological or orthopedic conditions that may interfere with ambulation; stable pharmacological therapy for at least 6 months. Exclusion criteria were: multiple sclerosis relapse during the three months prior to recruitment; presence of paroxysmal vertigo; lower limb botulinum toxin injections within the previous 12 weeks; cardiorespiratory instability; high-risk of spontaneous fracture; lower-limb skin lesions and phlebitis/thrombosis; more than 130 kg body weight.\n\nRandomization Forty out of 150 outpatients with relapsing remitting multiple sclerosis form, according to Polman criteria14 selected between January 2015-2016, were enrolled and randomized and allocated into either Group1 (G1 i.e. Lokomat-Nanos) or Group2 (G2 i.e. Lokomat-Pro), as shown in fig 1. The subjects were randomly assigned to one of two treatment groups, using a simple randomization scheme generated by a software (www.randomization.com). Individual, sequentially numbered index cards with the random assignments were prepared. The index cards were folded and placed in sealed opaque envelopes. A physician member of the research team, who was blinded to the baseline examination findings, opened the envelopes to attribute the interventions according to the group assignments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe walking disability with Expanded Disability Status Score (EDSS) between 3.5 and 6.0 (Pyramidal subitem ≥3)\n* Montreal Cognitive Assessment score ≥24\n* Absence of concomitant neurological or orthopedic conditions that may interfere with ambulation.\n\nExclusion Criteria:\n\n* MS relapse during the three months prior to recruitment\n* Not well defined pharmacological therapy; presence of paroxysmal vertigo\n* Lower limb botulinum toxin injections within the previous 12 weeks\n* Cardiorespiratory instability high-risk of spontaneous fracture\n* Lower-limb skin lesions and phlebitis/thrombosis\n* More than 130kg body weight'}, 'identificationModule': {'nctId': 'NCT02834533', 'briefTitle': 'Role of Virtual Reality in MS Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Centro Neurolesi Bonino Pulejo'}, 'officialTitle': 'Robotic Gait Training in Multiple Sclerosis: a Randomized Clinical Trial Evaluating Virtual Reality Role', 'orgStudyIdInfo': {'id': '24/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'column heading in tables.', 'description': 'The group 1 (G1, n=20) underwent Lokomat-Nanos training. Each patient underwent 40 1h-training sessions (for 3 times a week). Both the study groups were treated by Lokomat (Hocoma Inc., Zurich, Switzerland), which includes a treadmill, a BWSS and two powered gait orthosis robotic actuators with integrated computer-controlled linear actuators at each hip and knee joint . The overall duration of Lokomat therapy, including the time to get on and off, was 60min, while the robotic gait training lasted around 40min.', 'interventionNames': ['Device: Lokomat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'row and column in table', 'description': "The group 2 (G2, n=20) underwent Lokomat-Pro training, with the same G1 sessions. The Pro device offers instead a VR through an Augmented Feedback Module, which provides instructive, stimulating, interactive, and direct feedbacks to enhance the patient's motivation by projecting his/her avatar while walking on a screen.", 'interventionNames': ['Device: Lokomat']}], 'interventions': [{'name': 'Lokomat', 'type': 'DEVICE', 'description': "Lokomat (Hocoma Inc., Zurich, Switzerland)includes a treadmill, a BWSS and two powered gait orthosis robotic actuators with integrated computer-controlled linear actuators at each hip and knee joint . As compared to Lokomat-Nanos, the Pro device offers a VR through an Augmented Feedback Module, which provides instructive, stimulating, interactive, and direct feedbacks to enhance the patient's motivation by projecting his/her avatar while walking on a screen.", 'armGroupLabels': ['column heading in tables.', 'row and column in table']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We are planning this.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Centro Neurolesi Bonino Pulejo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Rocco Salvatore Calabrò', 'investigatorAffiliation': 'IRCCS Centro Neurolesi Bonino Pulejo'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-08-19', 'type': 'RELEASE'}, {'date': '2020-09-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rocco Salvatore Calabrò, Prof, IRCCS Centro Neurolesi Bonino Pulejo'}}}}