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Cerebral PalsyGames4CPNCT07158424

Serious Games for Serious Outcomes: Enhancing Cognition, Balance, and Quality of Life in Children With Cerebral Palsy

A study testing Serious games, Intensive rehabilitation and Physical therapy in people with Cerebral Palsy, run by Nataliya Hrabarchuk at 1 site in Ukraine.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Children with cerebral palsy (CP) often face challenges with balance, movement, and skills such as memory, problem-solving, and attention. These difficulties can affect not only daily activities but also their quality of life. Read more about this study

Who is it for?
Ages 6 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Cerebral Palsy
What is being tested?
Serious games, Intensive rehabilitation and Physical therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUkraine
Study dates
11 Nov 2024to 2 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 6 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Diagnosis of cerebral palsy
  • Ability to attend the educational institutions
  • GMFCS I, II, III

Who cannot join

  • GMFCS IV, V
  • Uncooperative behaviour
  • Uncontrolled seizures

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dr Anna D Kushnir, MD contact

+380991813741

anna@ic.reha.lviv.ua

Ukraine1 site, 1 recruiting
  • Elita Rehabilitation Center

    Lviv, Lviv Oblast, 79019

    Recruiting

Other trials in Ukraine

About this study

Official title: Effects of Serious Games on Cognitive Function, Balance, and Quality of Life in Children With Cerebral Palsy: a Randomized Controlled Trial

Children with cerebral palsy (CP) often face challenges with balance, movement, and skills such as memory, problem-solving, and attention. These difficulties can affect not only daily activities but also their quality of life. Rehabilitation usually focuses on physical therapy, but recent research shows that combining movement training with cognitive tasks may be even more effective.

What we are studying. This study is focused at whether serious games from the Vana Vital platform-that was specifically designed for rehabilitation-can improve balance, cognition, and quality of life in children with CP. These games are not ordinary video games: they were created to encourage children to move, focus, and solve problems at the same time (dual-tasking).

Read more

The expected benefits include:

  • Better trunk control and stability.
  • Improved memory, attention, and reasoning.
  • Enhanced participation in daily life and overall well-being.

Takeaway. This study is exploring an innovative approach to rehabilitation: using technology and games not only to strengthen the body but also to train the mind. If successful, this method may provide a fun, effective, and family-friendly addition to traditional therapies for children with CP.

Read the detailed description

Background. Cerebral palsy (CP) is one of the most common causes of movement difficulties in children. It is a lifelong condition that affects posture, coordination, and the ability to control movements. Many children with CP also experience challenges in other areas, such as attention, memory, and problem-solving. These challenges can make everyday tasks, school activities, and social participation more difficult.

Traditional rehabilitation programs focus on improving physical functions, especially motor control and balance. Training only movement may not be enough. Children may benefit from approaches that combine movement and cognitive training-practicing how to move while also thinking, remembering, or making quick decisions.

This idea is called dual-tasking: doing two things at the same time, such as walking while answering a question, or maintaining balance while remembering a sequence. In real life, dual-tasking is what we do constantly-walking while talking to a friend, keeping balance while carrying a schoolbag, or focusing in class while sitting upright. For children with CP, dual-tasking can be particularly difficult, but also particularly beneficial to practice.

Serious games are a new, innovative way to provide this training. Unlike ordinary video games, serious games are designed specifically for therapeutic purposes. They are meant to be engaging and motivating for children, while at the same time targeting key skills in motor and cognitive development.

What Makes This Study Unique. This study is among the first randomized controlled trials to test the Vana Vital platform-a suite of computer-based serious games that combine physical movements with cognitive tasks. Instead of repetitive exercises, children engage in playful adventures that require them to move their bodies while also solving challenges.

Study Design in Practice. The study follows the structure of a prospective, single-blind randomized controlled trial, which means that children are randomly assigned to groups, and the evaluators do not know which group each child belongs to (to reduce bias).

Group allocation:

Experimental Group 1: Standard rehabilitation program + serious games. Control Group 1: Standard rehabilitation program only. Control Group 2: Standard program + 30 extra minutes of physical therapy daily.

This design allows researchers to see whether serious games add benefits beyond standard care.

Expected outcomes for children include:

Stronger trunk control and better stability when sitting, standing, or walking. Improved memory, attention, and problem-solving skills. A more positive experience of rehabilitation, making therapy feel less like work and more like play.

Potential improvements in everyday life, such as sitting upright in school, playing with peers, or participating in family activities.

What Health Care Providers Can Expect For clinicians, this study provides structured evidence on the feasibility and effectiveness of adding game-based dual-task training to rehabilitation.

Conclusion This study represents a step forward in child-centered rehabilitation. Instead of seeing therapy as hard work, children can experience it as an adventure with Woo in fun, interactive worlds. By training both the body and the mind, serious games have the potential to improve balance, cognition, and overall quality of life for children with cerebral palsy.

The results of this randomized controlled trial will help healthcare providers understand whether game-based dual-tasking should become a regular part of rehabilitation programs-and will give families hope for more enjoyable, effective, and innovative ways to support their children's development.

Conditions
Cerebral Palsy
Being tested
Serious games, Intensive rehabilitation, Physical therapy
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Serious gamesProcedure or surgery

    Participants in the experimental groups engage in daily sessions of serious games from the Vana Vital Platform (Super Surfer, Hungry Woo, Paddle Waddle, Woo's Wonderful World Adventure). Each child will for 30 minutes per day over 10 training days.

  • Intensive rehabilitationProcedure or surgery

    Participants receive their intensive rehabilitation program, which includes:

    30 minutes of physical therapy (PT) 20 minutes of occupational therapy 5 minutes of spinal manipulative therapy 60 minutes of full-body massage with reflexotherapy 15 minutes of joint mobilization 15 minutes of treadmill gait training (with or without suspension) 15 minutes of strength training 30 minutes of group rhythmic gymnastics

  • Physical therapyProcedure or surgery

    Participants receive an additional 30 minutes of physical therapy (PT)

Study groups in NCT07158424
Study groupRoleWhat they receive
Standard rehabilitation program + serious gamesExperimentalParticipants in the experimental groups engage in daily sessions of serious games from the Vana Vital Platform. Each child play for 30 minutes per day over 10 training days. In addition, participants continue their intensive rehabilitation program.
Receives: Procedure: Serious games; Procedure: Intensive rehabilitation
Standard rehabilitation program + 30 extra minutes of physical therapyActive comparatorParticipants receive their intensive rehabilitation program, with an additional 30 minutes of physical therapy
Receives: Procedure: Intensive rehabilitation; Procedure: Physical therapy
Standard rehabilitation program onlyActive comparatorParticipants receive their intensive rehabilitation program.
Receives: Procedure: Intensive rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Score of the Trunk control measurement scale (TCMS)

    The TCMS is a standardized test used to evaluate trunk control in children with cerebral palsy. Trunk control is essential for posture, balance, and movement. A physiotherapist administers the test while the child sits without back or arm support and performs tasks that assess static sitting, selective trunk movements, and dynamic reaching. Each task is scored from 0 (unable) to 2 (able), with a maximum total of 58 points: 20 for static sitting, 28 for selective movement, and 10 for dynamic reaching. Higher scores indicate better trunk control and postural stability. Lower scores reflect greater difficulty with maintaining balance and controlling trunk movements. The test usually takes 15-20 minutes to complete and has been validated for children with CP. Changes in TCMS scores are considered clinically meaningful, as they reflect improvements in motor function, daily activities, and participation.

    Measured: Baseline and 2 weeks

Secondary outcomes (4)
  1. Characteristics of the Static Balance Test

    The Static Balance Test is a computerized assessment delivered through the Vana Vital platform to measure a child's ability to maintain a steady posture while standing still. During the test, the child stands on a Nintendo Wii balance board, and subtle movements of the body are recorded by sensors. The system quantifies postural sway in multiple directions (forward-backward, left-right) and provides objective data on trunk and overall balance control. The test is performed under standardized conditions, lasting 30 seconds overall per trial, with the child instructed to stand as still as possible. Results are expressed as stability scores. Lower sway values reflect better postural stability, while higher sway values indicate reduced balance control. The test is non-invasive, quick to administer, and was specifically designed for children with cerebral palsy. Improvements over time are interpreted as gains in trunk stability and postural control.

    Measured: Baseline and 2 weeks

  2. Score of the cognitive tests from Sway Medical platform

    The SWAY Medical platform provides sensor-based cognitive assessments designed for use on a tablet or smartphone. In this study, children complete short interactive tasks that measure key aspects of cognitive function, including executive functions, attention, and working memory. The tests are administered through a touch screen, requiring children to respond quickly and accurately to visual or auditory prompts. Each task lasts up to 5 mins, has 3 attempts, and provides objective, quantitative scores. The assessments are non-invasive, and validated for use in pediatric and rehabilitation settings. Results allow clinicians to monitor changes in cognition alongside motor outcomes, helping to evaluate the added value of dual-task serious game interventions in children with cerebral palsy.

    Measured: Baseline and 2 weeks

  3. Score of the RAVEN's coloured progressive matrices (RCMP)

    The RCPM is a non-verbal cognitive assessment used in children to measure general intelligence, focusing on reasoning and abstract thinking. It consists of a series of visual patterns with one piece missing; the child is asked to choose the correct missing piece from several options. The coloured version is specifically designed for younger children and those with developmental or physical challenges, as the coloured backgrounds help sustain attention and motivation. The test requires no reading, writing, or spoken language, making it suitable for children with CP and varying communication abilities. Administration typically takes 15-20 minutes. Scores are reported as the total number of correct responses (0-36), with higher scores reflecting stronger general intelligence. Results are often compared to age-based normative data to determine developmental level. The RCPM is quick, reliable, and sensitive to cognitive changes in clinical and rehabilitation research.

    Measured: Baseline and 2 weeks

  4. Score of the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)

    The PQ-LES-Q is a brief, standardized questionnaire used to assess short-term changes in quality of life in children and adolescents. It evaluates domains such as physical health, mood, school performance, social relationships, and overall life satisfaction. Each item is scored on a Likert-type scale (1 = Strongly Disagree to 5 = Strongly Agree), with higher total scores reflecting greater quality of life and satisfaction. The measure is child-friendly, quick to administer (approximately 5-10 minutes), and sensitive to short-term improvements during rehabilitation programs. It complements objective motor and cognitive outcomes by capturing how children feel and function in everyday life, thereby providing a holistic picture of the impact of serious game-based interventions.

    Measured: Baseline and 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2025
  2. Study start11 Nov 2024
  3. Primary completion2 Jan 2026 (estimated)
  4. Study completion2 Jan 2026 (estimated)

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07158424
Sponsor's protocol ID
ElitaRehab
Acronym
Games4CP
Status last verified
Aug 2025
First submitted
28 Aug 2025
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This study involves children with cerebral palsy, who are considered a vulnerable population. Informed consent procedures clearly state that individual-level data will not be shared and that all personal information will remain coded and confidential. Therefore, no individual participant data (IPD) will be made publicly available. Only aggregated, de-identified results will be reported in scientific publications and presentations.

Publications

  • Endicott J, Nee J, Yang R, Wohlberg C. Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q): reliability and validity. J Am Acad Child Adolesc Psychiatry. 2006 Apr;45(4):401-7. doi: 10.1097/01.chi.0000198590.38325.81.

    PubMed 16601644
  • Pueyo R, Junque C, Vendrell P, Narberhaus A, Segarra D. Raven's Coloured Progressive Matrices as a measure of cognitive functioning in Cerebral Palsy. J Intellect Disabil Res. 2008 May;52(Pt 5):437-45. doi: 10.1111/j.1365-2788.2008.01045.x. Epub 2008 Feb 28.

    PubMed 18312310
  • Heyrman L, Molenaers G, Desloovere K, Verheyden G, De Cat J, Monbaliu E, Feys H. A clinical tool to measure trunk control in children with cerebral palsy: the Trunk Control Measurement Scale. Res Dev Disabil. 2011 Nov-Dec;32(6):2624-35. doi: 10.1016/j.ridd.2011.06.012. Epub 2011 Jul 14.

    PubMed 21757321
  • Kushnir A, Kachmar O. Intensive Neurophysiological Rehabilitation System for children with cerebral palsy: a quasi-randomized controlled trial. BMC Neurol. 2023 Apr 20;23(1):157. doi: 10.1186/s12883-023-03216-4.

    PubMed 37081406
  • Kachmar O, Kushnir A, Fedchyshyn B, Cristiano J, O'Flaherty J, Helland K, Johnson G, Puig D. Personalized balance games for children with cerebral palsy: A pilot study. J Pediatr Rehabil Med. 2021;14(2):237-245. doi: 10.3233/PRM-190666.

    PubMed 33720857
  • Szturm T, Parmar ST, Mehta K, Shetty DR, Kanitkar A, Eskicioglu R, Gaonkar N. Game-Based Dual-Task Exercise Program for Children with Cerebral Palsy: Blending Balance, Visuomotor and Cognitive Training: Feasibility Randomized Control Trial. Sensors (Basel). 2022 Jan 19;22(3):761. doi: 10.3390/s22030761.

    PubMed 35161508
  • Stadskleiv K. Cognitive functioning in children with cerebral palsy. Dev Med Child Neurol. 2020 Mar;62(3):283-289. doi: 10.1111/dmcn.14463. Epub 2020 Jan 9.

    PubMed 32010976

Questions about this trial

What is this clinical trial studying?

A study testing Serious games, Intensive rehabilitation and Physical therapy in people with Cerebral Palsy, run by Nataliya Hrabarchuk at 1 site in Ukraine.

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: looking for participants now, as of the sponsor's last update on 5 Sep 2025. 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 Ukraine. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr Anna D Kushnir, MD (+380991813741, anna@ic.reha.lviv.ua), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score of the Trunk control measurement scale (TCMS) (time frame: Baseline and 2 weeks). 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 NCT07158424, which also lists 7 linked publications.

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 5 Sep 2025.

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