NCT03002285

Brief Summary

Introduction: Cerebral palsy (CP) is a non-progressive disorder in the brain which makes the control and execution of movements difficult. One of the possible ways to analyze motor control in these individuals could be through analysis of movement speed and accuracy. Objective: To verify the speed-accuracy trade-off in individuals with CP. Method: 96 individuals were evaluated, 48 with CP and 48 with typical development (TD), matched by age and sex. The software used was the "Fitts' Reciprocal Aiming Task v.1.0 (Horizontal)", performed on a computer using an external optical mouse, with progressive indices of difficulty (IDs): ID2, ID4a and ID4b. Each index of difficulty was performed three times and the total time/touches captured.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
Last Updated

December 23, 2016

Status Verified

December 1, 2016

Enrollment Period

7 months

First QC Date

December 19, 2016

Last Update Submit

December 20, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Motor control test by using a fitts law task in computational task

    one day

Study Arms (2)

Cerebral Palsy group

EXPERIMENTAL

Group with Cerebral Palsy that performed the Fitts law in a computer task

Behavioral: Cerebral Palsy group

Control group

ACTIVE COMPARATOR

Group with typical development that performed the Fitts law in a computer task

Behavioral: Control group

Interventions

Group with Cerebral Palsy that performed the Fitts law in a computer task

Cerebral Palsy group
Control groupBEHAVIORAL

Group with typical development that performed the Fitts law in a computer task

Control group

Eligibility Criteria

Age7 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • medical diagnosis of CP;
  • levels I to IV according to the GMFCS;
  • levels I to III according to MACS.

You may not qualify if:

  • presence of surgery or a chemical neuromuscular blockade in the upper limbs within six months prior to participation in the study;
  • lack of comprehension of the experimental instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fernani DCGL, Prado MTA, da Silva TD, Massetti T, de Abreu LC, Magalhaes FH, Dawes H, de Mello Monteiro CB. Evaluation of speed-accuracy trade-off in a computer task in individuals with cerebral palsy: a cross-sectional study. BMC Neurol. 2017 Jul 27;17(1):143. doi: 10.1186/s12883-017-0920-4.

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Carlos BM Monteiro, Ph.D.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 23, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

December 23, 2016

Record last verified: 2016-12