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Domiciliary VR Rehabilitation

Primary Purpose

Hemiparesis, Functional Independence, Movement Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Domiciliary VR-based motor rehabilitation
Domiciliary occupational therapy for motor rehabilitation
Sponsored by
Universitat Pompeu Fabra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiparesis

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Hemorrhagic or ischemic stroke
  • Subject had the stroke more than 12 months ago.
  • Subject presents mild-to-moderate upper-limbs hemiparesis (Proximal Medial Research Council Scale>2) secondary to a first-ever stroke.
  • Age between 45 and 85 years old.
  • Subject has previous experience using the RGS system in the clinic.

Exclusion Criteria:

  • Subject presents a major cognitive impairment (Mini-Mental State Evaluation> 22).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    VR-based therapy

    Control

    Arm Description

    3 weeks of home-based treatment for motor training using a virtual reality rehabilitation setup.

    3 weeks of home-based occupational therapy for motor training.

    Outcomes

    Primary Outcome Measures

    Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical

    Secondary Outcome Measures

    Change in depression as measured by the Hamilton scale
    Change in motor function as measured by the Medical Research Council scale
    Change in spasticity for the upper arms as measured by the Ashworth scale
    Change in cognitive function as measured by the Mini-mental State Evaluation test
    Change in Grip Force as measured by a grip dynamometer
    Change in shoulder pain as measured by the Visual Analog Assessment scale
    Change in motor function as measured by the upper extremity Fugl-Meyer Assessment

    Full Information

    First Posted
    February 25, 2016
    Last Updated
    February 29, 2016
    Sponsor
    Universitat Pompeu Fabra
    Collaborators
    Hospital del Mar, Hospital Vall d'Hebron
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02699398
    Brief Title
    Domiciliary VR Rehabilitation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitat Pompeu Fabra
    Collaborators
    Hospital del Mar, Hospital Vall d'Hebron

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is superior than domiciliary occupational therapy for inducing functional gains, enhancing corticospinal excitability, and cortical reorganization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemiparesis, Functional Independence, Movement Disorder, Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    VR-based therapy
    Arm Type
    Experimental
    Arm Description
    3 weeks of home-based treatment for motor training using a virtual reality rehabilitation setup.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    3 weeks of home-based occupational therapy for motor training.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Domiciliary VR-based motor rehabilitation
    Intervention Description
    3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Domiciliary occupational therapy for motor rehabilitation
    Intervention Description
    3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.
    Primary Outcome Measure Information:
    Title
    Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical
    Time Frame
    At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
    Secondary Outcome Measure Information:
    Title
    Change in depression as measured by the Hamilton scale
    Time Frame
    At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
    Title
    Change in motor function as measured by the Medical Research Council scale
    Time Frame
    At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
    Title
    Change in spasticity for the upper arms as measured by the Ashworth scale
    Time Frame
    At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
    Title
    Change in cognitive function as measured by the Mini-mental State Evaluation test
    Time Frame
    At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
    Title
    Change in Grip Force as measured by a grip dynamometer
    Time Frame
    At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
    Title
    Change in shoulder pain as measured by the Visual Analog Assessment scale
    Time Frame
    At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
    Title
    Change in motor function as measured by the upper extremity Fugl-Meyer Assessment
    Time Frame
    At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Hemorrhagic or ischemic stroke Subject had the stroke more than 12 months ago. Subject presents mild-to-moderate upper-limbs hemiparesis (Proximal Medial Research Council Scale>2) secondary to a first-ever stroke. Age between 45 and 85 years old. Subject has previous experience using the RGS system in the clinic. Exclusion Criteria: Subject presents a major cognitive impairment (Mini-Mental State Evaluation> 22).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul Verschure, PhD
    Organizational Affiliation
    Synthetic Perceptive, Emotive and Cognitive Systems group, Department of Information and Communication Technologies at the Universitat Pompeu Fabra (UPF).
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28784593
    Citation
    Ballester BR, Nirme J, Camacho I, Duarte E, Rodriguez S, Cuxart A, Duff A, Verschure PFMJ. Domiciliary VR-Based Therapy for Functional Recovery and Cortical Reorganization: Randomized Controlled Trial in Participants at the Chronic Stage Post Stroke. JMIR Serious Games. 2017 Aug 7;5(3):e15. doi: 10.2196/games.6773.
    Results Reference
    derived

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    Domiciliary VR Rehabilitation

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