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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

February 3, 2026

Last Update Submit

February 18, 2026

Conditions

Keywords

Activity ParticipationHemiparetic Cerebral PalsyMicrosoft Xbox KinectUpper Extremity FunctionVideo-based Games

Outcome Measures

Primary Outcomes (3)

  • Duruöz Hand Index

    The Duruöz Hand Index is an 18-item questionnaire designed to evaluate hand functional capacity. The index consists of five domains: kitchen activities, dressing, personal hygiene, work-related activities, and other daily activities. The questionnaire was completed by parents or caregivers. Responses are scored on a 6-point Likert scale ranging from 0 ("no difficulty") to 5 ("impossible"), yielding a total score between 0 and 90. Higher scores indicate greater impairment of hand function. The validity and reliability of the index for children aged 7-16 years with spastic hemiparetic cerebral palsy have been demonstrated previously.

    Baseline and immediately after the end of the treatment

  • Assistance to Participation Scale

    The Assistance to Participation Scale was developed by Bourke-Taylor, Law, Howie, and Pallant to assess the level of assistance required by school-aged children (5-18 years) with developmental disabilities to participate in play, leisure, and recreational activities from the caregiver's perspective. The scale consists of eight items, including activities such as watching television, listening to music, playing alone at home, playing outdoors near home, spending time with friends at home or at a friend's house, visiting playgrounds, and participating in recreational clubs. Items are rated on a 5-point Likert scale, with lower scores indicating lower participation levels and higher scores indicating greater participation.

    Baseline and immediately after the end of the treatment

  • Nine-Hole Peg Test

    The Nine-Hole Peg Test was used to assess fine motor skills of the fingers and hand for both upper extremities. Participants were instructed to place nine pegs (3.2 cm in length) into holes on a pegboard as quickly as possible using the dominant hand, followed by removal of the pegs in sequence. The total time required for insertion and removal was recorded in seconds, and the same procedure was repeated for the non-dominant hand. Insertion and removal times for both hands were documented separately. During the task, palmar, lateral, and hook grasp patterns were predominantly observed.

    Baseline and immediately after the end of the treatment

Study Arms (2)

Study

EXPERIMENTAL

Participants in the study group received 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.

Other: neurodevelopmental treatment (NDT)Other: Video-Based Gaming Training Using Microsoft Xbox

Control

ACTIVE COMPARATOR

Participants in the control group received neurodevelopmental treatment (NDT) four times per week, with each session lasting 45 minutes, for a total duration of 12 weeks.

Other: neurodevelopmental treatment (NDT)

Interventions

Neurodevelopmental Treatment Upper extremity rehabilitation based on the principles of neurodevelopmental treatment was designed to improve functional use of the upper extremity during daily activities such as dressing, writing, and feeding through the use of everyday objects.

ControlStudy

Video-Based Gaming Training Using Microsoft Xbox Participants in the study group received video-based gaming training using the Microsoft Xbox gaming console equipped with the Kinect motion-sensing system. Training sessions were conducted twice weekly for 45 minutes over a 12-week period. Each session included volleyball, table tennis, and bowling games, with each game played for 15 minutes. Participants performed the games in a comfortable position, either sitting or standing, depending on individual ability (Figure 2). The Kinect sensor captured full-body movements without the need for wearable markers, and the movements of the participants were mirrored in real time by a virtual avatar on the screen.

Study

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • aged between 7 and 13 years
  • diagnosis of spastic hemiparetic cerebral palsy
  • participants to be classified at levels I, II, or III according to the Gross Motor Function Classification System (GMFCS) and at levels I, II, or III according to the Manual Ability Classification System (MACS).

You may not qualify if:

  • Children who had undergone upper extremity tendon release surgery or received botulinum toxin injections within the previous six months
  • additional neurological disorders other than cerebral palsy
  • permanent orthopedic conditions affecting upper extremity function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale Üniversitesi

Denizli, Pamukkale, 20100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 19, 2026

Study Start

October 1, 2023

Primary Completion

March 1, 2025

Study Completion

May 1, 2025

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations