Fitts Law in People With Cerebral Palsy

NCT ID: NCT03002285

Last Updated: 2016-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The software used in this study was "Fitts' Reciprocal Aiming Task v.1.0 (Horizontal)" developed by Okazaki, in the public domain and available on the Internet, which was performed on a Toshiba notebook®, model Satellite A60-S1561 System Unit, with the use of an external optical mouse, Fortrek® OM-302.

This instrument can be used to verify motor control through analysis of the speed and accuracy of movement, which can be determined through the log-linear relation between movement time and task difficulty using a mathematical equation, and analyzed by Fitts' law, which describes the relation between movement accuracy and speed, associated with target size and distance11. Thus, the task used in this study was composed of targets of different sizes, being that the smaller targets require more time to execute due to the necessity of increased accuracy and, if the distance between targets reduces, the speed of movement becomes greater and the accuracy decreases.

In relation to target size (W) and distance between targets (D), the equation log2 (2D/W) results in an index of difficulty (ID), where the higher the ID, the more difficult the task, a fact that necessitates greater movement time.

To evaluate the speed and accuracy, two different indices of difficulty were used in this study (ID2 and ID4). The difficulty level was increased by changing the width and distance between the bars. In addition, ID4 was used in two different ways (ID4a and ID4b), for which the distance between the bars and the width were different, but the ID was maintained.

3 Procedure and design The experiment was composed of three trials at each of the two IDs: 2 and 4 (ID 4 had two kinds of measurement - ID4a and ID4b), and the participants performed the tasks individually in a room, with only the evaluator present, seated on a chair (or their own wheelchair), which was adjusted in height according to the needs of the individual. A footrest was available, when necessary. The computer was placed on a table, and each participant was given instructions and presented with the task, in which the individual, after hearing an alarm from the computer, was required to click with an external mouse cursor on two parallel bars which were arranged vertically, intermittently, with the greatest speed and accuracy possible, for a period of 10 seconds, followed by a second alarm which indicated the end of the attempt.

Directly following the attempt, the total movement time was registered, by dividing the seconds obtained in each attempt by the number of "clicks" on targets. If more than two clicks were wrong, the individual repeated the task.

Procedure and design The experiment was composed of three trials at each of the two IDs: 2 and 4 (ID 4 had two kinds of measurement - ID4a and ID4b), and the participants performed the tasks individually in a room, with only the evaluator present, seated on a chair (or their own wheelchair), which was adjusted in height according to the needs of the individual. A footrest was available, when necessary. The computer was placed on a table, and each participant was given instructions and presented with the task, in which the individual, after hearing an alarm from the computer, was required to click with an external mouse cursor on two parallel bars which were arranged vertically, intermittently, with the greatest speed and accuracy possible, for a period of 10 seconds, followed by a second alarm which indicated the end of the attempt.

Directly following the attempt, the total movement time was registered, by dividing the seconds obtained in each attempt by the number of "clicks" on targets. If more than two clicks were wrong, the individual repeated the task.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cerebral Palsy group

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

Group Type EXPERIMENTAL

Cerebral Palsy group

Intervention Type BEHAVIORAL

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

Control group

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

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cerebral Palsy group

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

Intervention Type BEHAVIORAL

Control group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carlos Bandeira de Mello Monteiro

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carlos BM Monteiro, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28750603 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14652713.9.0000.0082

Identifier Type: -

Identifier Source: org_study_id