Cerebral Palsy InfantileNCT06616610
Single-Button Mobility Platform's Effect on Reaction Time and Keystroke Accuracy in Children with Cerebral Palsy
A study testing Intervention with the Mobility Platform and Intervention with Traditional Therapy in people with Cerebral Palsy Infantile, run by University of Seville at 1 site in Spain.
Trial summary
The goal of this clinical trial is to determine whether the use of a mobility platform can improve response time in children with cerebral palsy. The primary question it seeks to answer is: Can the use of a mobility platform enhance cognitive development in children with severe disabilities? Children are randomly… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Cerebral Palsy Infantile
- What is being tested?
- Intervention with the Mobility Platform and Intervention with Traditional Therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with cerebral palsy
- Classified as GMFCS level IV or higher, indicating an inability to walk or operate a powered wheelchair.
- Under 12 years old.
- Must be affiliated to a center whose facilities guarantee a proper navigation experience
Who cannot join
- Inability to act on an actuator (Start button)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Seville
Seville, Andalusia, 41010
Félix Biscarri, PhD, +34 954552826, fbiscarri@us.es
Alberto Molina, PhD, +34 954552787, almolina@us.es
About this study
Official title: Single-Button Mobility Platform's Effect on Reaction Time and Keystroke Accuracy in Children with Cerebral Palsy: a Pilot Study
The goal of this clinical trial is to determine whether the use of a mobility platform can improve response time in children with cerebral palsy.
The primary question it seeks to answer is: Can the use of a mobility platform enhance cognitive development in children with severe disabilities?
Read more
Children are randomly assigned to two equal-sized groups: the control group, where participants will continue with their standard therapy, and the intervention group, where participants will use the mobility platform. Researchers will compare outcomes between the two groups.
Participants in the control group will engage in a traditional cause-and-effect therapy, using a video that frequently pauses, requiring them to press an adapted button to continue watching. Participants in the intervention group will use the mobility platform during their sessions. Movement begins when the participant presses the adapted button, and the platform advances, adjusting its direction using sensors to detect obstacles. Once the preset time limit is reached, the platform stops, and the child must press the button again to resume movement. This stop-start process mirrors the cause-and-effect training in the control group.
Read the detailed description
The experimental timeline includes eight weekly sessions, each lasting 30 minutes. Initially, therapists will receive an explanation on how to use the platform and the accompanying configuration application. They will familiarize themselves with it a couple of weeks before the experiment begins. During the sessions, children in the experimental group will use the platform, while those in the control group will continue receiving their traditional therapy.
Researchers will pre-adjust the children\'s interactions to match the platform variables, allowing for meaningful comparisons. Therapists will assess changes in the children's mood or emotional state during each session. To do this, they will calculate the differences between the SAM (Self-Assessment Manikin) tests conducted at the beginning and end of each session. A positive difference in valence indicates an improvement in the participant\'s happiness or positive emotions during the session. Similarly, positive changes in arousal reflect increased calmness or reduced excitation. A seven-item Likert scale will be used for measurement. For instance, if there is a positive change of seven points in valence during a session, the participant moves from a very sad state to a very happy one.
To minimize bias in conducting the experiment and evaluating SAM tests, therapists will be randomly assigned to either the control or intervention groups for each session, while ensuring an equal number of sessions conducted by each therapist. As a result, each therapist will conduct four sessions with the experimental group and four with the control group, with random session assignments.
The dependent variables include reaction time (RT) and the number of incorrect selections (NIS). The mean and standard deviation of these dependent variables allow for the following statistical analyses: Kruskal-Wallis Test: This will be used to compare the dependent variables across groups. SAM Test: It will score the statistically significant differences between the experimental and control groups, with the level of significance set at 5% (p = 0.05). Pearson Regression Analysis: This will identify trends in the dependent variables over time.
The registration procedure is as follows: Variables are collected, transmitted, and stored in a database on a cellphone for later analysis. To achieve this, the investigators used an Open Source Frontend SDK , which enables the deployment of hybrid mobile applications based on web development tools such as HTML, CSS, and JavaScript. The apps run in a browser shell. Several Capacitor plugins were used to manage the database and Bluetooth connectivity, which are essential for data storage and communication. The application interface includes buttons for therapists to enable/disable Bluetooth connections, start/stop recording, and a panic button to halt the platform and abort the experiment. Additionally, users can select their username and group name. Control group therapy involves the use of educational resources that require children to press a button repeatedly. For this group, the investigators chose fairy tale or cartoon videos from YouTube. The specific videos will be tailored to the user's preferences. These videos pause intermittently and require the child to perform an action to resume playback. A microcontroller is used to record time intervals and host an application that detects the child's keystrokes. This data is transmitted via Bluetooth to the same mobile application used for the mobility platform, ensuring synchronization between the experimental and control groups.
- Conditions
- Cerebral Palsy Infantile
- Being tested
- Intervention with the Mobility Platform, Intervention with Traditional Therapy
- Keywords
- Cerebral Palsy, Children, Reaction Time, mobility platform, cognitive development, GMFCS levels IV-V, motor skills
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with the Mobility PlatformBehavioural
The experimental arm receives the Intervention with Mobility Platform that is a focus of the study. It aims to analyze the impact of a single-button-operated mobility platform on reaction times and keypress patterns in children with severe disabilities.
Intervention with Traditional TherapyBehavioural
The traditional cause-effect therapies use an animated cartoon video that frequently pauses so that the children have to press an adapted button to continue watching it.
| Study group | Role | What they receive |
|---|---|---|
| The Experimental Arm | Experimental | Participants included in arms are children with the following inclusion criteria:
* Diagnosed with cerebral palsy
* Classified as GMFCS level IV or higher, indicating an inability to walk or operate a powered wheelchair.
* Under 12 years old.
* Must be affiliated to a center whose facilities guarantee a proper navigation experience
The participants will be randomly assigned to two equal-sized arms: the control arm, in which participants will continue with the traditional therapy, and the experimental arm, where the children will use the platform.
The experimental arm receives an intervention (procedure) that is a focus of the study. It aims to analyze the impact of a single-button-operated mobility platform on reaction times and keypress patterns in children with severe disabilities. Receives: Behavioral: Intervention with the Mobility Platform |
| The Control Arm | Active comparator | Participants included in arms are children with the following inclusion criteria: - Diagnosed with cerebral palsy - Classified as GMFCS level IV or higher, indicating an inability to walk or operate a powered wheelchair. - Under 12 years old. - Must be affiliated to a center whose facilities guarantee a proper navigation experience The participants will be randomly assigned to two equal-sized arms: the control arm, in which participants will continue with the traditional therapy, and the experimental arm, where the children will use the platform. The control arm participants continue with their regular therapy. Regular cause-effect therapies use an animated cartoon video that frequently pauses so that the children have to press an adapted button to continue watching it. Receives: Behavioral: Intervention with Traditional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time (RT)
In the intervention group, RT measures the time elapsed between the platform stopping and the user pressing the button to initiate a new navigation period.
In the control group, RT measures the time elapsed between the video pausing and the user pressing the button to continue watching it
Measured: From enrollment to the end of treatment at 8 weeks
Number of incorrect selections (NIS)
NIS represents the number of additional button presses recorded while the Platform is in motion and serves validation purposes. A high value of this variable, consistently maintained over time, suggests that the user is not performing the cause-effect experiment effectively.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (1)
The Self-Assessment Manikin (SAM) test
The Self-Assessment Manikin (SAM) test is used to assess the emotional changes in children during the experiment. It comprises a 7-level Likert scale (the scale ranges from 1 to 7) associated with a set of faces displaying various degrees of valence and arousal.
Valence reflects how pleasant or unpleasant an emotion. A score of 1 represents the most unpleasant emotion, while a score of 7 represents the most pleasant emotion.
Arousal refers to the level of physiological and psychological activation or intensity of an emotional experience. A score of 1 indicates low arousal (low physiological and psychological activation), and a score of 7 indicates high arousal (high activation).
Thus, higher scores mean more positive valence (pleasant emotion) and higher arousal (greater intensity).
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Jan 2024
- Primary completionJan 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy InfantileStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Félix Biscarri Triviño, University of Seville
- Investigators
- Alberto Molina Cantero, PhD, Principal investigator, University of Seville, Seville, Andalucia, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616610
- Sponsor's protocol ID
- PEIBA_0669-N-22
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Button Mobility Platform's Effect on Reaction Time and Keystroke Accuracy in Children with Cerebral Palsy: a Pilot Study
- ClinicalTrials.gov ID
- NCT06616610
- Acronym / sponsor ID
- PEIBA_0669-N-22
- Conditions
- Cerebral Palsy Infantile
- Keywords
- Cerebral Palsy, Children, Reaction Time, mobility platform, cognitive development, GMFCS levels IV-V, motor skills
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 27 Sep 2024 (actual)
- 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.
The goal of this clinical trial is to determine whether the use of a mobility platform can improve response time in children with cerebral palsy.
The primary question it seeks to answer is: Can the use of a mobility platform enhance cognitive development in children with severe disabilities?
Children are randomly assigned to two equal-sized groups: the control group, where participants will continue with their standard therapy, and the intervention group, where participants will use the mobility platform. Researchers will compare outcomes between the two groups.
Participants in the control group will engage in a traditional cause-and-effect therapy, using a video that frequently pauses, requiring them to press an adapted button to continue watching. Participants in the intervention group will use the mobility platform during their sessions. Movement begins when the participant presses the adapted button, and the platform advances, adjusting its direction using sensors to detect obstacles. Once the preset time limit is reached, the platform stops, and the child must press the button again to resume movement. This stop-start process mirrors the cause-and-effect training in the control group.
Detailed description
The experimental timeline includes eight weekly sessions, each lasting 30 minutes. Initially, therapists will receive an explanation on how to use the platform and the accompanying configuration application. They will familiarize themselves with it a couple of weeks before the experiment begins. During the sessions, children in the experimental group will use the platform, while those in the control group will continue receiving their traditional therapy.
Researchers will pre-adjust the children\'s interactions to match the platform variables, allowing for meaningful comparisons. Therapists will assess changes in the children's mood or emotional state during each session. To do this, they will calculate the differences between the SAM (Self-Assessment Manikin) tests conducted at the beginning and end of each session. A positive difference in valence indicates an improvement in the participant\'s happiness or positive emotions during the session. Similarly, positive changes in arousal reflect increased calmness or reduced excitation. A seven-item Likert scale will be used for measurement. For instance, if there is a positive change of seven points in valence during a session, the participant moves from a very sad state to a very happy one.
To minimize bias in conducting the experiment and evaluating SAM tests, therapists will be randomly assigned to either the control or intervention groups for each session, while ensuring an equal number of sessions conducted by each therapist. As a result, each therapist will conduct four sessions with the experimental group and four with the control group, with random session assignments.
The dependent variables include reaction time (RT) and the number of incorrect selections (NIS). The mean and standard deviation of these dependent variables allow for the following statistical analyses: Kruskal-Wallis Test: This will be used to compare the dependent variables across groups. SAM Test: It will score the statistically significant differences between the experimental and control groups, with the level of significance set at 5% (p = 0.05). Pearson Regression Analysis: This will identify trends in the dependent variables over time.
The registration procedure is as follows: Variables are collected, transmitted, and stored in a database on a cellphone for later analysis. To achieve this, the investigators used an Open Source Frontend SDK , which enables the deployment of hybrid mobile applications based on web development tools such as HTML, CSS, and JavaScript. The apps run in a browser shell. Several Capacitor plugins were used to manage the database and Bluetooth connectivity, which are essential for data storage and communication. The application interface includes buttons for therapists to enable/disable Bluetooth connections, start/stop recording, and a panic button to halt the platform and abort the experiment. Additionally, users can select their username and group name. Control group therapy involves the use of educational resources that require children to press a button repeatedly. For this group, the investigators chose fairy tale or cartoon videos from YouTube. The specific videos will be tailored to the user's preferences. These videos pause intermittently and require the child to perform an action to resume playback. A microcontroller is used to record time intervals and host an application that detects the child's keystrokes. This data is transmitted via Bluetooth to the same mobile application used for the mobility platform, ensuring synchronization between the experimental and control groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Experimental Arm | Experimental | Behavioral: Intervention with the Mobility PlatformParticipants included in arms are children with the following inclusion criteria: * Diagnosed with cerebral palsy * Classified as GMFCS level IV or higher, indicating an inability to walk or operate a powered wheelchair. * Under 12 years old. * Must be affiliated to a center whose facilities guarantee a proper navigation experience The participants will be randomly assigned to two equal-sized arms: the control arm, in which participants will continue with the traditional therapy, and the experimental arm, where the children will use the platform. The experimental arm receives an intervention (procedure) that is a focus of the study. It aims to analyze the impact of a single-button-operated mobility platform on reaction times and keypress patterns in children with severe disabilities. |
| The Control Arm | Active comparator | Behavioral: Intervention with Traditional TherapyParticipants included in arms are children with the following inclusion criteria: - Diagnosed with cerebral palsy - Classified as GMFCS level IV or higher, indicating an inability to walk or operate a powered wheelchair. - Under 12 years old. - Must be affiliated to a center whose facilities guarantee a proper navigation experience The participants will be randomly assigned to two equal-sized arms: the control arm, in which participants will continue with the traditional therapy, and the experimental arm, where the children will use the platform. The control arm participants continue with their regular therapy. Regular cause-effect therapies use an animated cartoon video that frequently pauses so that the children have to press an adapted button to continue watching it. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosed with cerebral palsy
- Classified as GMFCS level IV or higher, indicating an inability to walk or operate a powered wheelchair.
- Under 12 years old.
- Must be affiliated to a center whose facilities guarantee a proper navigation experience
Key exclusion criteria (1 listed)
- Inability to act on an actuator (Start button)
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 |
|---|---|---|
| Intervention with the Mobility PlatformThe experimental arm receives the Intervention with Mobility Platform that is a focus of the study. It aims to analyze the impact of a single-button-operated mobility platform on reaction times and keypress patterns in children with severe disabilities. | Behavioural | The Experimental Arm |
| Intervention with Traditional TherapyThe traditional cause-effect therapies use an animated cartoon video that frequently pauses so that the children have to press an adapted button to continue watching it. | Behavioural | The Control Arm |
Primary outcome
Reaction time (RT)
Time frame: From enrollment to the end of treatment at 8 weeks
In the intervention group, RT measures the time elapsed between the platform stopping and the user pressing the button to initiate a new navigation period. In the control group, RT measures the time elapsed between the video pausing and the user pressing the button to continue watching it
Number of incorrect selections (NIS)
Time frame: From enrollment to the end of treatment at 8 weeks
NIS represents the number of additional button presses recorded while the Platform is in motion and serves validation purposes. A high value of this variable, consistently maintained over time, suggests that the user is not performing the cause-effect experiment effectively.
1 secondary outcome
The Self-Assessment Manikin (SAM) test
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- The Self-Assessment Manikin (SAM) is a non-verbal tool used to measure emotional responses across three dimensions: valence (pleasure), arousal, and dominance.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD used in the results publication.
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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.
Alberto Molina Cantero, PhD principal investigator
University of Seville, Seville, Andalucia, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention with the Mobility Platform and Intervention with Traditional Therapy in people with Cerebral Palsy Infantile, run by University of Seville at 1 site in Spain.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Félix Biscarri, PhD (+34 954552836, fbiscarri@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time (RT) (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.