About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Intervention with the Mobility Platform
BehavioralThe 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
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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
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.
Secondary outcomes
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).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.