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Intensive Video-Based Game Therapy Applications in Cerebral Palsy

NCT ID: NCT06821815

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2026-01-10

Brief Summary

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This study investigates the effectiveness of intensive video game-based rehabilitation and intensive bimanual activity-based therapy for improving motor skills and daily living activities in individuals with spastic cerebral palsy (CP). Given the importance of high-frequency, short-duration interventions in CP rehabilitation, the research compares these two approaches while ensuring participants receive no additional therapy during the study.

Twenty children (ages 4-18) with GMFCS levels 1-2 and MACS levels 1-3 will be randomly assigned to one of the two groups. The video game-based group will complete 28 structured sessions over two weeks, including 20 individual sessions and 8 group sessions. The control group will follow an identical schedule using bimanual goal-oriented activities. Assessments will be conducted before, after, and three months post-intervention using validated motor and functional performance measures.

By standardizing task contents between groups, the study aims to provide objective results and contribute to CP rehabilitation by identifying an effective, time-efficient, and cost-effective therapy option using exergames and serious games.

Detailed Description

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Cerebral Palsy (CP) is the most common physical disability observed in childhood. Due to the motor function losses observed in individuals with CP, their participation in activities is restricted. Rehabilitation approaches applied to develop motor skills and functional independence in individuals with CP are currently implemented with a target-oriented approach based on motor learning. In this context, video game-based rehabilitation programs are also frequently applied today. The principles of implementation, therapy durations, and session frequencies of motor learning-based rehabilitation approaches in CP rehabilitation vary in the literature. Most application methods are applied over a long period. However, nowadays, it is important to apply these therapy practices for a shorter duration but with high session frequency and intensity to achieve motor skill and functional independence goals in a shorter time.In light of this information, the study aims to investigate the effectiveness of an intensive video game-based rehabilitation program and an intensive bimanual activity-based therapy program for motor skills and daily living activities in individuals with CP. Applying video game-based rehabilitation programs in an intensive format to achieve the targeted functional improvements in upper extremity functions and motor skills in a short time and comparing the effectiveness of this approach with another intensive therapy program, while ensuring that the groups do not receive any other rehabilitation approach during the application period, makes our study unique. The study will include 20 children diagnosed with spastic cerebral palsy, aged 4-18, with Gross Motor Function Classification System (GMFCS) levels 1-2, Manual Ability Classification System (MACS) levels 1-3, who can follow given visual and verbal commands, Communication Function Classification System (CFCS) levels 1-2, Visual Function Classification System (VFCS) levels 1-2, who continue the program within the specified times, and who agree not to receive any therapy other than the one assigned randomly to their group during the study and sign the consent form. In the study, before, after, and 3 months after the 2-week rehabilitation program, assessments will be made using a demographic form, Gross Motor Function Measure-88 (GMFM-88), Canadian Occupational Performance Measure (COPM), Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT), Box \& Block Test, Upper Extremity Selective Motor Control Scale (SCUES), and Becure Balance System. The study group will receive a total of 28 sessions of intensive and structured video game-based rehabilitation, consisting of 20 individual sessions (5 days a week, 2 sessions per day, each session lasting 30-45 minutes) and 8 group training sessions over 2 weeks. The control group will also follow the same plan for 2 weeks, receiving a total of 28 sessions of intensive bimanual goal-oriented activity-based intervention. Care will be taken to ensure that the task contents applied between the two programs are similar to obtain objective results. The therapeutic approach determined and applied during this project, designed with exergames and serious games, is expected to guide professionals working in the field of CP. In this way, it will be possible to find solutions to patients' problems with the most effective and fastest treatment option and at a lower cost.

Conditions

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Cerebral Palsy (CP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Assessor of the study protocol wont be able to have knowledge about assigned group of participants.

Participants wont be aware about groups.

Study Groups

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Video Game Based Therapy Group

In this group an Intensive video game based therapy program will be applied to participants. Therapy program aimed for the motor function of upper extremities and postural control. Therapy program includes 10 individual 4 group sessions per week, 28 sessions in total with each session lasts 40 minutes. Total duration of this intervention is 2 weeks.

Group Type EXPERIMENTAL

Video Game Based Therapy

Intervention Type OTHER

Video game based therapy interventions includes active video games for rehabilitation. Leap Motion Controller based rehabilitative games, Xbox Kinect Games and Kinect Based Custom Rehabilitative Games will be applied to the participants

Bimanual Intensive Therapy Group

In this group an Bimanual Intensive therapy program will be applied to participants. Therapy program aimed for the motor function of upper extremities and postural control. Therapy program includes 10 individual 4 group sessions per week, 28 sessions in total with each session lasts 40 minutes. Total duration of this intervention is 2 weeks.

Group Type ACTIVE_COMPARATOR

Bimanual Intensive Therapy

Intervention Type OTHER

This intervention includes goal directed activity based exercises for upper extremity functions. This intervention also includes exercises for postural control

Interventions

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Video Game Based Therapy

Video game based therapy interventions includes active video games for rehabilitation. Leap Motion Controller based rehabilitative games, Xbox Kinect Games and Kinect Based Custom Rehabilitative Games will be applied to the participants

Intervention Type OTHER

Bimanual Intensive Therapy

This intervention includes goal directed activity based exercises for upper extremity functions. This intervention also includes exercises for postural control

Intervention Type OTHER

Other Intervention Names

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Virtual Reality Active Video Game Exergame

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Spastic Cerebral Palsy
* Gross Motor Function Classification level I-II
* Manual Ability Classification level I-III
* Communication Function Classification System I-II
* No botox injections 6 months prior to the intervention

Exclusion Criteria

* Visual problems which may effect the interventions
* Secondary conditions such as intellectual disability, epilepsy
* Having surgical procedure related to musculoskeletal system 1 year prior to he study
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Emir

DR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmet Emir, Emir

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

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Cerebral Palsy Türkiye Foundation

Istanbul, Ataşehir, Turkey (Türkiye)

Site Status RECRUITING

Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ahmet Emir, PhD

Role: CONTACT

[email protected]
+90 216 681 1500 ext. 1895

Facility Contacts

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Duygu Uslu

Role: primary

+90 536 386 86 74

Ahmet Emir, PhD

Role: primary

[email protected]
+90 216 681 1500 ext. 1895

References

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Bleyenheuft Y, Arnould C, Brandao MB, Bleyenheuft C, Gordon AM. Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) in Children With Unilateral Spastic Cerebral Palsy: A Randomized Trial. Neurorehabil Neural Repair. 2015 Aug;29(7):645-57. doi: 10.1177/1545968314562109. Epub 2014 Dec 19.

Reference Type BACKGROUND
PMID: 25527487 (View on PubMed)

Other Identifiers

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E-10840098-202.3.02-7476

Identifier Type: -

Identifier Source: org_study_id