Cerebral PalsyNCT07421193
Effect of Video-Based Games on Upper Extremity Function in Children With Hemiparetic Cerebral Palsy
A study testing neurodevelopmental treatment (NDT) and Video-Based Gaming Training Using Microsoft Xbox in people with Cerebral Palsy and Video Game, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Cerebral Palsy, Video Game
- What is being tested?
- neurodevelopmental treatment (NDT) and Video-Based Gaming Training Using Microsoft Xbox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale Üniversitesi
Denizli, Pamukkale, 20100
About this study
Official title: The Effect of Video-Based Games on Upper Extremity Function and Activity Participation in Children With Hemiparetic Cerebral Palsy
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.
Read more
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.
Read the 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).
- Conditions
- Cerebral Palsy, Video Game
- Being tested
- neurodevelopmental treatment (NDT), Video-Based Gaming Training Using Microsoft Xbox
- Keywords
- Activity Participation, Hemiparetic Cerebral Palsy, Microsoft Xbox Kinect, Upper Extremity Function, Video-based Games
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurodevelopmental treatment (NDT)Other
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.
Video-Based Gaming Training Using Microsoft XboxOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: neurodevelopmental treatment (NDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and immediately after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Oct 2023
- Primary completion1 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Tekin, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421193
- Sponsor's protocol ID
- Şengül Dr Tez
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sen Tekin S, Yarar F. The effect of video-based games on upper extremity function and activity participation in children with hemiparetic cerebral palsy. Dev Neurorehabil. 2026 Oct 10:1-8. doi: 10.1080/17518423.2026.2738676. Online ahead of print.
PubMed 42857931
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video-Based Games on Upper Extremity Function and Activity Participation in Children With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07421193
- Acronym / sponsor ID
- Şengül Dr Tez
- Conditions
- Cerebral Palsy, Video Game
- Keywords
- Activity Participation, Hemiparetic Cerebral Palsy, Microsoft Xbox Kinect, Upper Extremity Function, Video-based Games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Other: neurodevelopmental treatment (NDT), Other: Video-Based Gaming Training Using Microsoft XboxParticipants 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. |
| Control | Active comparator | Other: neurodevelopmental treatment (NDT)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. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurodevelopmental treatment (NDT)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. | Other | Control, Study |
| Video-Based Gaming Training Using Microsoft XboxVideo-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. | Other | Study |
Primary outcome
Duruöz Hand Index
Time frame: Baseline and immediately after the end of the treatment
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.
Assistance to Participation Scale
Time frame: Baseline and immediately after the end of the treatment
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.
Nine-Hole Peg Test
Time frame: Baseline and immediately after the end of the treatment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Derived from this study: PubMed 42857931Sen Tekin S, Yarar F. The effect of video-based games on upper extremity function and activity participation in children with hemiparetic cerebral palsy. Dev Neurorehabil. 2026 Oct 10:1-8. doi: 10.1080/17518423.2026.2738676. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurodevelopmental treatment (NDT) and Video-Based Gaming Training Using Microsoft Xbox in people with Cerebral Palsy and Video Game, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duruöz Hand Index (time frame: Baseline and immediately after the end of the treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07421193, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.