Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616610
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Single-Button Mobility Platforms Effect on Reaction Time and Keystroke Accuracy in Children with Cerebral Palsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single-Button Mobility Platforms Effect on Reaction Time and Keystroke Accuracy in Children with Cerebral Palsy a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 children39s interactions to match the platform variables allowing for meaningful comparisons Therapists will assess changes in the childrens 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 participantampamp39s 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 005 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 enabledisable Bluetooth connections startstop 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 users 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 childs 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
Researchers will pre-adjust the children39s interactions to match the platform variables allowing for meaningful comparisons Therapists will assess changes in the childrens 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 participantampamp39s 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 005 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 enabledisable Bluetooth connections startstop 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 users 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 childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None