NCT03352440

Brief Summary

A computer program was developed with the same task, but with two possibilities of user interaction: a) interface with contact: in which the individual touches the computer screen to finish the task and b) interface without contact: in which the individual perform a hand movement in front of the Kinect. Were evaluated 29 individuals with CP who constituted the experimental group and 28 individuals without deficiency who composed the control group with matching age and sex.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

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

January 20, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

November 17, 2017

Last Update Submit

April 30, 2018

Conditions

Keywords

Cerebral PalsyVirtual Reality Exposure TherapyLearningMotor ActivityMotor Skills

Outcome Measures

Primary Outcomes (1)

  • Improvement of performance on Touchscreen interface provided by the Kinect system.

    The number of bubbles reached with the attempts will show the improvement of performance.

    one day

Study Arms (4)

Cerebral Palsy - Kinect

EXPERIMENTAL

Group with Cerebral Palsy that will perform the task on Kinect

Device: Cerebral Palsy - Kinect

Cerebral Palsy - Touchscreen

EXPERIMENTAL

Group with Cerebral Palsy that will perform the task on Touchscreen

Device: Cerebral Palsy - Touchscreen

Control Group - Kinect

ACTIVE COMPARATOR

Group with typical development that will perform the task on Kinect

Device: Control Group - Kinect

Control Group - Touchscreen

ACTIVE COMPARATOR

Group with typical development that will perform the task on Touchscreen

Device: Control Group - Touchscreen

Interventions

Group with Cerebral Palsy that will perform the task on Kinect

Cerebral Palsy - Kinect

Group with Cerebral Palsy that will perform the task on Touchscreen

Cerebral Palsy - Touchscreen

Group with typical development that will perform the task on Kinect

Control Group - Kinect

Group with typical development that will perform the task on Touchscreen

Control Group - Touchscreen

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • individuals with a diagnosis PC (for the experimental group);
  • diparesis and spastic hemiparesis;
  • with gross motor function classification as levels I, II and III according to the Gross Motor Function Classification System (GMFCS).

You may not qualify if:

  • individuals who have undergone surgery or performing chemical neuromuscular blockade for less than 6 months in the upper limbs;
  • associated diseases;
  • changes in cognitive functions that preclude cooperation and understanding in the proposed activities.

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

Related Publications (1)

  • Leal AF, da Silva TD, Lopes PB, Bahadori S, de Araujo LV, da Costa MVB, de Moraes IAP, Marques RH, Crocetta TB, de Abreu LC, Monteiro CBM. The use of a task through virtual reality in cerebral palsy using two different interaction devices (concrete and abstract) - a cross-sectional randomized study. J Neuroeng Rehabil. 2020 Apr 29;17(1):59. doi: 10.1186/s12984-020-00689-z.

MeSH Terms

Conditions

Cerebral PalsyMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Officials

  • Carlos BM Monteiro, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 24, 2017

Study Start

January 20, 2017

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations