- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03002285
Fitts Law in People With Cerebral Palsy
Evaluation of Speed-accuracy Trade-off in a Computer Task in Individuals With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cerebral Palsy group
Group with Cerebral Palsy that performed the Fitts law in a computer task
|
Group with Cerebral Palsy that performed the Fitts law in a computer task
|
|
Active Comparator: Control group
Group with typical development that performed the Fitts law in a computer task
|
Group with typical development that performed the Fitts law in a computer task
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Motor control test by using a fitts law task in computational task
Time Frame: one day
|
one day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlos BM Monteiro, Ph.D., University of São Paulo
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14652713.9.0000.0082
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Ankara City Hospital BilkentRecruitingCerebral Palsy (CP) | Cerebral Palsy, Spastic, Diplegic | Diplegic Cerebral Palsy With Spasticity | Transcranial Magnetic StimilationTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesRecruiting
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RecruitingCerebral Palsy (CP) | Hemiplegic Cerebral PalsyCanada
-
Cairo UniversityCompletedCerebral Palsy (CP) | Unilateral Cerebral PalsyEgypt
-
University of California, San FranciscoNot yet recruitingCerebral Palsy | Cerebral Palsy (CP) | Infant | Cerebral Palsy InfantileUnited States
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
IRCCS Fondazione Stella MarisNot yet recruitingCerebral Palsy (CP) | EEG | Unilateral Cerebral Palsy | Action ObservationItaly
-
IRCCS Fondazione Stella MarisUniversity of Siena, ItalyRecruitingCerebral Palsy (CP) | Motor Imagery | CP (Cerebral Palsy) | Action ObservationItaly
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
Clinical Trials on Cerebral Palsy group
-
University of Sao PauloCompleted
-
Cairo UniversityCompletedSpastic Cerebral PalsyEgypt
-
National Taiwan University HospitalCompletedCerebral Palsy | Crouch GaitTaiwan
-
Istanbul UniversityCompletedCerebral Palsy | Gait Disorders, Neurologic | Gait Disorders in Children | Gait AnalysisTurkey
-
University of British ColumbiaCompletedQuality of Life | Cerebral Palsy | Patient Undergoing Hip SurgeryCanada
-
Riphah International UniversityHelping Hand Institute of Rehabilitation SciencesRecruiting
-
Riphah International UniversityCompletedCerebral Palsy (CP) | Range of Motion | Spasticity | Functional MobilityPakistan
-
Acıbadem Atunizade HospitalCompletedCommunication Disorder, Childhood | Cerebral Palsy, Spastic Quadriplegic | Gross Motor DelayTurkey
-
Kafrelsheikh UniversityNot yet recruitingDiplegic Cerebral PalsyEgypt
-
Nationwide Children's HospitalUnknown