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Intensive Video-Based Game Therapy Applications in Cerebral Palsy

M

Medipol University

Status

Enrolling

Conditions

Cerebral Palsy (CP)

Treatments

Other: Video Game Based Therapy
Other: Bimanual Intensive Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06821815
E-10840098-202.3.02-7476

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 estimated patients

Sex

All

Ages

6 to 14 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Video Game Based Therapy Group
Experimental group
Description:
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.
Treatment:
Other: Video Game Based Therapy
Bimanual Intensive Therapy Group
Active Comparator group
Description:
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.
Treatment:
Other: Bimanual Intensive Therapy

Trial contacts and locations

2

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Central trial contact

Ahmet Emir, PhD

Data sourced from clinicaltrials.gov

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