Serious Game Therapy in Neglect Patients

NCT05805748 | Completed

• 1 other identifier: NSU-SG 5M
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Unilateral Spatial Neglect

Keywords

rehabilitation; new technology; unilateral spatial neglect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Catherine Bergego Scale (CBS)

  up to 6 weeks

• Functional Independence Measure (FIM)

  up to 6 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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)

Behavioral: serious game rehabilitation

Group 2

ACTIVE COMPARATOR

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)

Behavioral: serious game rehabilitation

Interventions

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).

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral spatial neglect syndrome
• Right cerebral lesion

You may not qualify if:

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

Sponsors & Collaborators

• Hopitaux de Saint-Maurice: lead

Study Sites (1)

Hôpitaux de Saint Maurice

Saint-Maurice, 94410, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 10, 2023
• Study Start: September 6, 2017
• Primary Completion: January 5, 2021
• Study Completion: July 1, 2022
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

FR (1)