Clinical trial NCT06616610: Single-Button Mobility Platform's Effect on Reaction Time and Keystroke Accuracy in Children with Cerebral Palsy
Official title: Single-Button Mobility Platform's Effect on Reaction Time and Keystroke Accuracy in Children with Cerebral Palsy: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy Infantile
Keywords: Cerebral Palsy
Children
Reaction Time
mobility platform
cognitive development
GMFCS levels IV-V
motor skills
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 4
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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\&#39;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\&amp;amp;#39;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.

Eligibility criteria: 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

Exclusion Criteria:

- Inability to act on an actuator (Start button)

Primary outcomes:
measure: Reaction time (RT)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Number of incorrect selections (NIS)
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: The Self-Assessment Manikin (SAM) test
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Seville
country: Spain
facility: University of Seville
state: Andalucia
Study officials:
affiliation: University of Seville, Seville, Andalucia, Spain
name: Alberto Molina Cantero, PhD
role: PRINCIPAL_INVESTIGATOR
References: