Motor Learning in People With Cerebral Palsy by Using Virtual Reality.

Comparative Analysis of Motor Performance in People With Cerebral Palsy (Spastic Hemiparesis) by Virtual Task.

Cerebral Palsy (CP) is a group of permanent disorders that affect movement and posture due to a non-progressive lesion in the immature brain occurring in fetal brain development or in infancy. These disorders are often associated with changes in sensation, learning, body perception, communication and behavior. People with CP present variable difficulties in muscle action. With increasing access to computer-aided accessibility, rehabilitation programs have increasingly used virtual reality (VR) environments to provide functional tasks. Virtual reality research in individuals with cerebral palsy has demonstrated improvements in gross motor functions and functional disabilities in mobility, and is a good device for rehabilitation. The present research is a cross-sectional study. For this study 40 individuals aged over six years (with task comprehension) of both gender who have a clinical diagnosis of spastic hemiparetic Cerebral Palsy will be evaluated. Thus, the present study aims to compare the motor function of the committed and uncommitted body side by performing tasks in virtual reality.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: Right hemiparesis, right upper limb.; Behavioral: Right hemiparesis, left upper limb; Behavioral: Left hemiparesis, left upper limb; Behavioral: Left hemiparesis, right upper limb

Detailed Description

METHOD The present research is a cross-sectional study. The study will be carried out at the School of Special Education Don Bosco, Rio Branco, Acre.

PARTICIPANTS (CASE) For this study 40 individuals aged over six years (with task comprehension) of both gender who have a clinical diagnosis of spastic hemiparetic Cerebral Palsy will be evaluated.

STUDY DESIGN The individuals selected will be divided according to the affected body side, forming a first group categorized by RH (Right Hemiparetic) and a second LH (Left Hemiparetic), and for the accomplishment of the activity in the RH group half will start the task with the affected side and than with the unaffected side and the same will be reproduced in the LH group. Before performing the matching Timing task, individuals will perform a simple reaction time (RT) task, with 14 repetitions in each task.

Next, they will perform 20 attempts of the Timing task in the acquisition phase (0.5 second speed between the firings of each sphere - level 4), after 10 minutes without contact with the task the subjects will carry out 5 attempts for the Retention phase at the same speed as the acquisition phase. Then the subjects will perform 5 more attempts for the transfer phase with change in the speed of the task (0.25 seconds between the firings of each sphere - level 5). After the task is finished, the TR will be applied again.

INSTRUMENTS Timing Software Coincident For the data collection will be used a software of games created in partnership with the group of Information Systems of the School of Arts, Sciences and Humanities, EACH-USP. The game proposes a Coincident Timing task, which displays on the computer screen 10 spheres that light up (red light) in sequence until reaching the last ball that is considered the target (Green light). The participant can have immediate feedback of correctness or error of the task through different sounds (Auditory Interaction) and through visual images (Visual Interaction) that change color previously demonstrated to them.

Software TRT_S (Simple Reaction Time) Other software used was TRT_S2012. Which was constructed and validated by Crocetta et al. The software proposes a simple TRT test consisting of the appearance of a yellow square (parameterizable) in the center of the monitor at predefined time intervals (ranging from 1.5 to 6.5 ms - these intervals were identical in both Software) and, when the stimulus is applied, the participant should react as quickly as possible by pressing the spacebar on the computer keyboard.

Procedure and design Participants will perform the task individually in a quiet room, with only the experimenter, who will provide the instructions. The computer monitor will be positioned on a desk. Participants will remain seated in the chair with height adjusted according to the needs of each. In addition, a footrest will be available if needed. The functional assessment scales will be performed at the beginning of the research, the experimenter will explain the task verbally and perform a demonstration of the game's functioning and interfaces (Kinect for Windows®, touch the computer key or touchscreen).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 03828-000
    • Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• classification of gross motor function with levels I and II according to the Gross Motor Function Classification System (GMFCS),
• MACS (Manual Ability Classification System) classification between levels I and II.

Exclusion Criteria:

• over 20 years;
• comorbidities that prevent the accomplishment of the activity;
• people with significant visual and cognitive impairment;
• those who have undergone chemical blockade or upper limb surgery for less than six months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Right hemiparesis, right upper limb; Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb.	Behavioral: Right hemiparesis, right upper limb.; Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb.
Experimental: Right hemiparesis, left upper limb; Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb.	Behavioral: Right hemiparesis, left upper limb; Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb.
Active Comparator: Left hemiparesis, left upper limb; Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb.	Behavioral: Left hemiparesis, left upper limb; Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb.
Experimental: Left hemiparesis, right upper limb; Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb.	Behavioral: Left hemiparesis, right upper limb; Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in performance of the Coincident Timing task between participants with right hemiparesis and participants with left hemiparesis	There will be differences between right and left hemiparesis regarding coincident timing (e.g. patients with left hemiparesis will have a worse time in milliseconds that patients with right hemiparesis).	6 months.

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Carlos BM Monteiro, Ph.D., University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2017
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 61384416.3.0000.8028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No