Serious Game Therapy in Neglect Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05805748
• Other study ID #: NSU-SG 5M
• Status: Completed
• Phase: N/A
• Start date: September 6, 2017
• Est. completion date: July 1, 2022

Study information

• Verified date: April 2023
• Source: Hopitaux de Saint-Maurice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 1, 2022
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Unilateral spatial neglect syndrome
• Right cerebral lesion

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Stroke
• Unilateral Spatial Neglect

Intervention

Behavioral:
• serious game rehabilitation
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).

Locations

Country	Name	City	State
France	Hôpitaux de Saint Maurice	Saint-Maurice

Sponsors (1)

Lead Sponsor	Collaborator
Hopitaux de Saint-Maurice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	up to 6 weeks
Secondary	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).	up to 6 weeks
Secondary	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.	up to 6 weeks