Ireland
--:--IST
Recruiting Not applicable

Single-Button Mobility Platform's Effect on Reaction Time and Keystroke Accuracy in Children with Cerebral Palsy

NCT06616610 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2024-01-01
Last updated
2024-10-15

Condition(s) studied

Cerebral Palsy Infantile

Investigational drug(s) / intervention(s)

Intervention with the Mobility PlatformIntervention with Traditional Therapy

Intervention with the Mobility Platform: 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 Therapy: 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 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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
12 Years
Healthy volunteers
No
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 outcome measure(s)

  • Reaction time (RT) — 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) — 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.

Trial sites (1)

FacilityCityRegionStatus
University of Seville Seville Andalusia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06616610 on ClinicalTrials.gov ↗ ← All trials in Spain