NCT07158424

Brief 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. 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). 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2026

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

August 28, 2025

Last Update Submit

August 28, 2025

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (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.

    Baseline and 2 weeks

Secondary Outcomes (4)

  • Characteristics of the Static Balance Test

    Baseline and 2 weeks

  • Score of the cognitive tests from Sway Medical platform

    Baseline and 2 weeks

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

    Baseline and 2 weeks

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

    Baseline and 2 weeks

Study Arms (3)

Standard rehabilitation program + serious games

EXPERIMENTAL

Participants 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.

Procedure: Serious gamesProcedure: Intensive rehabilitation

Standard rehabilitation program + 30 extra minutes of physical therapy

ACTIVE COMPARATOR

Participants receive their intensive rehabilitation program, with an additional 30 minutes of physical therapy

Procedure: Intensive rehabilitationProcedure: Physical therapy

Standard rehabilitation program only

ACTIVE COMPARATOR

Participants receive their intensive rehabilitation program.

Procedure: Intensive rehabilitation

Interventions

Serious gamesPROCEDURE

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.

Standard rehabilitation program + serious games
Intensive rehabilitationPROCEDURE

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

Standard rehabilitation program + 30 extra minutes of physical therapyStandard rehabilitation program + serious gamesStandard rehabilitation program only
Physical therapyPROCEDURE

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

Standard rehabilitation program + 30 extra minutes of physical therapy

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • GMFCS IV, V
  • Uncooperative behaviour
  • Uncontrolled seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elita Rehabilitation Center

Lviv, Lviv Oblast, 79019, Ukraine

RECRUITING

Related Publications (7)

  • 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.

    PMID: 16601644BACKGROUND

  • 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.

    PMID: 18312310BACKGROUND

  • 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.

    PMID: 21757321BACKGROUND

  • 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.

    PMID: 37081406BACKGROUND

  • 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.

    PMID: 33720857BACKGROUND

  • 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.

    PMID: 35161508BACKGROUND

  • 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.

    PMID: 32010976BACKGROUND

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Central Study Contacts

Dr Anna D Kushnir, MD

CONTACT

+380991813741anna@ic.reha.lviv.ua

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 5, 2025

Study Start

November 11, 2024

Primary Completion

January 2, 2026

Study Completion

January 2, 2026

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

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.

Locations

UA(1)