Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07421193
Brief Summary:
Aim:
The present study aimed to systematically evaluate the effects of video-based gaming on upper extremity motor function and activity participation in children with hemiparetic cerebral palsy (CP). Specifically, it investigated whether Microsoft Xbox Kinect games leveraging motion-detection technology, when added to conventional neurodevelopmental therapy (NGT), would provide additional benefits in motor skill development, independence in activities, social engagement, motivation, and treatment adherence compared to NGT alone.
Materials and Methods:
Twenty-four children aged 7-13 years with hemiparetic CP, classified as Level I-III on the Gross Motor Function Classification System (GMFCS) and Level 1-3 on the Manual Ability Classification System (MACS), were recruited. Participants were randomized into intervention (n=12) and control (n=12) groups. The control group received NGT four times per week (45-minute sessions) over a 12-week period. The intervention group received two NGT sessions and two Xbox Kinect gameplay sessions per week, each lasting 45 minutes, over the same duration.
Outcome measures included the Nine-Hole Peg Test (9HPT) to assess timed hand performance, the Duruöz Hand Index (DHI) to evaluate skill-based hand function, and the Assistance to Participation Scale (APS) to assess participation in daily activities. All assessments were conducted by a blinded expert physiotherapist at baseline and after the intervention period.
Detailed Description:
A total of 27 children meeting the inclusion criteria will be enrolled in the study, and demographic information will be recorded using a standardized data collection form. Participants who do not complete the intervention protocol will be withdrawn from the study. Eligible participants will be randomly assigned to either the study group or the control group using a simple randomization method.
Participants in the control group will receive neurodevelopmental treatment (NDT) four times per week, with each session lasting 45 minutes, for a total duration of 12 weeks. Participants in the study group will receive NDT twice per week (45 minutes per session) in addition to video-based gaming training using Microsoft Xbox twice per week (45 minutes per session) for 12 weeks.
Outcome assessments will be conducted at baseline and at the end of the 12-week intervention period by an experienced physiotherapist who will be blinded to group allocation. Upper extremity performance will be assessed using the Nine-Hole Peg Test (9HPT), hand function will be evaluated using the Duruöz Hand Index (DHI), and participation in daily activities will be assessed using the Assistance to Participation Scale (APS).
Study:
NCT07421193
Study Brief:
Protocol Section:
NCT07421193