Therapeutic Serious Game and Rehabilitation of Stroke Patient

December 13, 2022 updated by: Hopitaux de Saint-Maurice

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unilateral spatial neglect syndrome
  • Right cerebral lesion

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Experimental group
Behavioral: Serious game rehabilitation
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bells test
Time Frame: up to 4 weeks
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.
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bisection of lines
Time Frame: up to 4 weeks
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.
up to 4 weeks
Ogden scene copying
Time Frame: up to 4 weeks
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).
up to 4 weeks
Reading task
Time Frame: up to 4 weeks
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.
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopitaux de Saint-Maurice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2016

Primary Completion (Actual)

June 3, 2017

Study Completion (Actual)

September 6, 2017

Study Registration Dates

First Submitted

November 21, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 22, 2022

Study Record Updates

Last Update Posted (Actual)

December 22, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSU-SG 5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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