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

NCT06616610 | Recruiting

• 1 other identifier: PEIBA_0669-N-22
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy Infantile

Keywords

Cerebral Palsy; Children; Reaction Time; mobility platform; cognitive development; GMFCS levels IV-V; motor skills

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (1)

• The Self-Assessment Manikin (SAM) test

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

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.

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.

Behavioral: Intervention with Traditional Therapy

Interventions

Intervention with the Mobility Platform BEHAVIORAL

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.

The Experimental Arm

Intervention with Traditional Therapy BEHAVIORAL

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.

The Control Arm

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- Inability to act on an actuator (Start button)

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

University of Seville

Seville, Andalusia, 41010, Spain

RECRUITING

Related Links

• The Self-Assessment Manikin (SAM) is a non-verbal tool used to measure emotional responses across three dimensions: valence (pleasure), arousal, and dominance.

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Methods

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Alberto Molina Cantero, PhD

  University of Seville, Seville, Andalucia, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Félix Biscarri, PhD

CONTACT

+34 954552836; fbiscarri@us.es

Alberto Molina Cantero, PhD

CONTACT

+34 954552787; almolina@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of research group

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 27, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From november 2024
• Access Criteria: Everyone will be able to access all the IPD and all the supporting information. It will be available on It will be available on the Research Data Repository of the University of Seville (IdUS). IdUS is part of the digital infrastructure for open science and offers University of Seville authors a platform to deposit their publications in open access and their research data.

Locations

ES (1)