Cerebral PalsyNCT03002285
Fitts Law in People With Cerebral Palsy
A study testing Cerebral Palsy group in people with Cerebral Palsy, run by University of Sao Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Cerebral Palsy group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- medical diagnosis of CP;
- levels I to IV according to the GMFCS;
- levels I to III according to MACS.
Who cannot join
- 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.
About this study
Official title: Evaluation of Speed-accuracy Trade-off in a Computer Task in Individuals With Cerebral Palsy
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Cerebral Palsy group, Control group
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral Palsy groupBehavioural
Group with Cerebral Palsy that performed the Fitts law in a computer task
Control groupBehavioural
Group with typical development that performed the Fitts law in a computer task
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Palsy group | Experimental | Group with Cerebral Palsy that performed the Fitts law in a computer task Receives: Behavioral: Cerebral Palsy group |
| Control group | Active comparator | Group with typical development that performed the Fitts law in a computer task Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor control test by using a fitts law task in computational task
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Bandeira de Mello Monteiro, University of Sao Paulo
- Investigators
- Carlos BM Monteiro, Ph.D., Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002285
- Sponsor's protocol ID
- 14652713.9.0000.0082
- Status last verified
- Dec 2016
- First submitted
- 19 Dec 2016
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28750603
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Speed-accuracy Trade-off in a Computer Task in Individuals With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03002285
- Acronym / sponsor ID
- 14652713.9.0000.0082
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebral Palsy group | Experimental | Behavioral: Cerebral Palsy groupGroup with Cerebral Palsy that performed the Fitts law in a computer task |
| Control group | Active comparator | Behavioral: Control groupGroup with typical development that performed the Fitts law in a computer task |
Who may qualify
- Ages
- 7 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- medical diagnosis of CP;
- levels I to IV according to the GMFCS;
- levels I to III according to MACS.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral Palsy groupGroup with Cerebral Palsy that performed the Fitts law in a computer task | Behavioural | Cerebral Palsy group |
| Control groupGroup with typical development that performed the Fitts law in a computer task | Behavioural | Control group |
Primary outcome
Motor control test by using a fitts law task in computational task
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
- Derived from this study: PubMed 28750603Fernani 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos BM Monteiro, Ph.D. principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral Palsy group in people with Cerebral Palsy, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor control test by using a fitts law task in computational task (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03002285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2016.