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Therapeutic Serious Game and Rehabilitation of Stroke Patient

Primary Purpose

Stroke, Unilateral Spatial Neglect

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Serious game rehabilitation
Sponsored by
Hopitaux de Saint-Maurice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring serious game, stroke, unilateral spatial neglect, rehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Unilateral spatial neglect syndrome Right cerebral lesion Exclusion Criteria: Epilepsia General mental deterioration Psychiatric disorder No prior history of neurological disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental group

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Bells test
    35 bells are spatially distributed among distractors on sheet of paper (15 on the left side, 5 on the center and 15 on the right side). Subjects have to cancel as many bells as possible. The number of omissions on the left and on the right side is recorded.

    Secondary Outcome Measures

    Bisection of lines
    2 lines of 200 millimeters are presented on a sheet of paper. Subjects have to mark the middle of the lines. The deviation from the objective middle is measured in millimeter.
    Ogden scene copying
    Copying of the 'Ogden scene' required participants to copy a scene that consisted of 2 trees, a fence and a house (shown from left to right side of the page). Each stroke in the scene to be copied was counted as a point; each omitted stroke was scored as one error, and each distorted or misplaced stroke was scored as one-half of an error (/4).
    Reading task
    A text of 116 words is presented with 61 words on the left side and 55 on the right side. Subjects have to read this text. Number of omissions on the left and on the right side is recorded.

    Full Information

    First Posted
    November 21, 2022
    Last Updated
    December 13, 2022
    Sponsor
    Hopitaux de Saint-Maurice
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05661396
    Brief Title
    Therapeutic Serious Game and Rehabilitation of Stroke Patient
    Official Title
    Development of a Therapeutic Serious Game in the Rehabilitation of Stroke Patient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 3, 2016 (Actual)
    Primary Completion Date
    June 3, 2017 (Actual)
    Study Completion Date
    September 6, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hopitaux de Saint-Maurice

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The growing field of new technologies offers new perspectives for neurorehabilitation. Serious games are a promising solution in the rehabilitation of cognitive impairments, and they may be useful in the rehabilitation of unilateral spatial neglect. The investigators developed a rehabilitation program for visual exploration training with a serious game and investigated its efficiency. Six patients with unilateral spatial neglect after a right hemispheric stroke were recruited. Three patients assigned to the experimental group received both serious game training and conventional rehabilitation, and three assigned to the control group received only conventional rehabilitation. The investigators compared the two groups after rehabilitation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Unilateral Spatial Neglect
    Keywords
    serious game, stroke, unilateral spatial neglect, rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    6 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Title
    Control group
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Serious game rehabilitation
    Intervention Description
    Three patients received therapeutic serious game rehabilitation in addition to conventional rehabilitation. The serious game was proposed to be played three times per week for four weeks, for a total of 12 sessions, with 15 min per session (= 45 minutes per week).
    Primary Outcome Measure Information:
    Title
    Bells test
    Description
    35 bells are spatially distributed among distractors on sheet of paper (15 on the left side, 5 on the center and 15 on the right side). Subjects have to cancel as many bells as possible. The number of omissions on the left and on the right side is recorded.
    Time Frame
    up to 4 weeks
    Secondary Outcome Measure Information:
    Title
    Bisection of lines
    Description
    2 lines of 200 millimeters are presented on a sheet of paper. Subjects have to mark the middle of the lines. The deviation from the objective middle is measured in millimeter.
    Time Frame
    up to 4 weeks
    Title
    Ogden scene copying
    Description
    Copying of the 'Ogden scene' required participants to copy a scene that consisted of 2 trees, a fence and a house (shown from left to right side of the page). Each stroke in the scene to be copied was counted as a point; each omitted stroke was scored as one error, and each distorted or misplaced stroke was scored as one-half of an error (/4).
    Time Frame
    up to 4 weeks
    Title
    Reading task
    Description
    A text of 116 words is presented with 61 words on the left side and 55 on the right side. Subjects have to read this text. Number of omissions on the left and on the right side is recorded.
    Time Frame
    up to 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Unilateral spatial neglect syndrome Right cerebral lesion Exclusion Criteria: Epilepsia General mental deterioration Psychiatric disorder No prior history of neurological disease

    12. IPD Sharing Statement

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    Therapeutic Serious Game and Rehabilitation of Stroke Patient

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