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Serious Game Therapy in Neglect Patients

Primary Purpose

Stroke, Unilateral Spatial Neglect

Status
Completed
Phase
Not Applicable
Locations
France
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 rehabilitation, new technology, unilateral spatial neglect

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

  • Hôpitaux de Saint Maurice

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Each patient received 2 rehabilitations : a serious game training and a conventional rehabilitation first (during 3 weeks) and then conventional rehabilitation alone (during 3 weeks)

Each patient received 2 rehabilitations for 3 weeks: a conventional rehabilitation first (during 3 weeks) and then both serious game training and a conventional rehabilitation (during 3 weeks)

Outcomes

Primary Outcome Measures

Behavioral Inattention Test (BIT)
Behavioral Inattention Test (Wilson et al., 1987) (BIT) including the first part of conventional subtests: star and letter cancellation, line crossing, figure and shape copying, line bisection and representational drawing (total score /146)

Secondary Outcome Measures

Catherine Bergego Scale (CBS)
CBS for therapist (Bergego et al., 1995) is based on the direct observation of the therapist in ten standardised dailylife situations. The score ranges from 0 to 30 (higher scores indicating more severe neglect).
Functional Independence Measure (FIM)
FIM (Minaire, 1991) is a basic indicator of patient disability. FIM is used to track the changes in the functional ability of a patient during an episode of hospital rehabilitation care.

Full Information

First Posted
March 27, 2023
Last Updated
April 7, 2023
Sponsor
Hopitaux de Saint-Maurice
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1. Study Identification

Unique Protocol Identification Number
NCT05805748
Brief Title
Serious Game Therapy in Neglect Patients
Official Title
Development of a Therapeutic Serious Game in the Rehabilitation of Stroke Patient
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
January 5, 2021 (Actual)
Study Completion Date
July 1, 2022 (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

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. Investigators developed a rehabilitation program for visual exploration training with a serious game and investigated its efficiency. Twelve patients with unilateral spatial neglect after a right hemispheric stroke were recruited. Six patients assigned to a group received both serious game training and conventional rehabilitation, and after only conventional rehabilitation; and six patients assigned to another group received first conventional rehabilitation and then serious game training and 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
rehabilitation, new technology, unilateral spatial neglect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each patient was assigned to a group who received 2 rehabilitations for 3 weeks, 1) both serious game training and a conventional rehabilitation first and then conventional rehabilitation alone (group 1, G1), or 2) a conventional rehabilitation first and then both serious game training and a conventional rehabilitation (group 2, G2).
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Each patient received 2 rehabilitations : a serious game training and a conventional rehabilitation first (during 3 weeks) and then conventional rehabilitation alone (during 3 weeks)
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Each patient received 2 rehabilitations for 3 weeks: a conventional rehabilitation first (during 3 weeks) and then both serious game training and a conventional rehabilitation (during 3 weeks)
Intervention Type
Behavioral
Intervention Name(s)
serious game rehabilitation
Intervention Description
The SG rehabilitation was proposed to be played four times per week for three weeks, for a total of 12 sessions, with 15 min per session (= 60 minutes per week). Conventional rehabilitation comprised five sessions of 45 min of neuropsychological rehabilitation using classical exploration training (= 225 minutes per week).
Primary Outcome Measure Information:
Title
Behavioral Inattention Test (BIT)
Description
Behavioral Inattention Test (Wilson et al., 1987) (BIT) including the first part of conventional subtests: star and letter cancellation, line crossing, figure and shape copying, line bisection and representational drawing (total score /146)
Time Frame
up to 6 weeks
Secondary Outcome Measure Information:
Title
Catherine Bergego Scale (CBS)
Description
CBS for therapist (Bergego et al., 1995) is based on the direct observation of the therapist in ten standardised dailylife situations. The score ranges from 0 to 30 (higher scores indicating more severe neglect).
Time Frame
up to 6 weeks
Title
Functional Independence Measure (FIM)
Description
FIM (Minaire, 1991) is a basic indicator of patient disability. FIM is used to track the changes in the functional ability of a patient during an episode of hospital rehabilitation care.
Time Frame
up to 6 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
Facility Information:
Facility Name
Hôpitaux de Saint Maurice
City
Saint-Maurice
ZIP/Postal Code
94410
Country
France

12. IPD Sharing Statement

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Serious Game Therapy in Neglect Patients

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