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Completed

NCT Number: NCT05805748

Serious Game Therapy in Neglect Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux de Saint Maurice

Saint-Maurice, 94410, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral spatial neglect syndrome
  • Right cerebral lesion

Exclusion criteria

  • Epilepsia
  • General mental deterioration
  • Psychiatric disorder
  • No prior history of neurological disease

Treatment and study plan

Serious game rehabilitation

Behavioral

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 outcomes

  1. Behavioral Inattention Test (BIT)

    Time frame: up to 6 weeks

    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 outcomes

  1. Catherine Bergego Scale (CBS)

    Time frame: up to 6 weeks

    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).

  2. Functional Independence Measure (FIM)

    Time frame: up to 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Hopitaux de Saint-Maurice

Other

Registry information

Official study title

Development of a Therapeutic Serious Game in the Rehabilitation of Stroke Patient

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Apr 10, 2023
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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