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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348943
• Other study ID #: 61384416.3.0000.8028
• Status: Completed
• Phase: N/A
• First received: June 1, 2017
• Last updated: November 21, 2017
• Start date: April 15, 2017
• Est. completion date: September 1, 2017

Study information

• Verified date: November 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Behavioral:
• Right hemiparesis, right upper limb.
Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb.
• Right hemiparesis, left upper limb
Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb.
• Left hemiparesis, left upper limb
Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb.
• Left hemiparesis, right upper limb
Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb.

Locations

Country	Name	City	State
Brazil	Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.