NCT03348943

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

June 1, 2017

Last Update Submit

November 21, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (4)

Right hemiparesis, right upper limb

ACTIVE COMPARATOR

Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb.

Behavioral: Right hemiparesis, right upper limb.

Right hemiparesis, left upper limb

EXPERIMENTAL

Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb.

Behavioral: Right hemiparesis, left upper limb

Left hemiparesis, left upper limb

ACTIVE COMPARATOR

Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb.

Behavioral: Left hemiparesis, left upper limb

Left hemiparesis, right upper limb

EXPERIMENTAL

Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb.

Behavioral: Left hemiparesis, right upper limb

Interventions

Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb.

Right hemiparesis, right upper limb

Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb.

Right hemiparesis, left upper limb

Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb.

Left hemiparesis, left upper limb

Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb.

Left hemiparesis, right upper limb

Eligibility Criteria

Age6 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo

São Paulo, 03828-000, Brazil

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Carlos BM Monteiro, Ph.D.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 1, 2017

First Posted

November 21, 2017

Study Start

April 15, 2017

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

November 24, 2017

Record last verified: 2017-11

Locations