Intensive Video-Based Game Therapy Applications in Cerebral Palsy

NCT06821815 | Completed

• 1 other identifier: E-10840098-202.3.02-7476
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cerebral Palsy (CP)

Keywords

video game based therapy; cerebral palsy; bimanual therapy

Outcome Measures

Primary Outcomes (2)

• Gross Motor Function changes over the Study - Gross Motor Performance Measure - 88 (GMFM-88)

  GMFM-88 is a assessment tool to evaluate gross motor functions in children with cerebral palsy. It evaluates motor functions in 5 dimensions and with 88 items total

  Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up

• Performance of Activities of Daily Living - Canadian Occupational Performance Measure (COPM)

  The Canadian Occupational Performance Measure (COPM) is a client-centered assessment tool that evaluates self-perceived performance and satisfaction in daily activities across three areas: self-care, productivity, and leisure. Clients identify up to five important but challenging activities and rate their performance and satisfaction on a 10-point scale (1 = extremely poor/not satisfied, 10 = excellent/completely satisfied). The total performance and satisfaction scores are averaged separately, with higher scores indicating better function and greater satisfaction. A change of 2 or more points is considered clinically significant.

  Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up

Secondary Outcomes (2)

• Changes on Motor Function for Upper Extremities - Selective Control of the Upper Extremity Scale (SCUES)

  Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up

• Changes on Motor Function for Upper Extremities - Box and Block Test

  Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up

Other Outcomes (1)

• Change of Postural Control

  Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up

Study Arms (2)

Video Game Based Therapy Group

EXPERIMENTAL

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.

Other: Video Game Based Therapy

Bimanual Intensive Therapy Group

ACTIVE COMPARATOR

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.

Other: Bimanual Intensive Therapy

Interventions

Video Game Based Therapy 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

Also known as: Virtual Reality, Active Video Game, Exergame

Video Game Based Therapy Group

Bimanual Intensive Therapy OTHER

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

Bimanual Intensive Therapy Group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (2)

Cerebral Palsy Türkiye Foundation

Istanbul, Ataşehir, Turkey (Türkiye)

Location

Istanbul Medipol University

Istanbul, Beykoz, 34815, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 25527487 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ahmet Emir, Emir

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Assessor of the study protocol wont be able to have knowledge about assigned group of participants. Participants wont be aware about groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: February 10, 2025
• Primary Completion: October 10, 2025
• Study Completion: January 10, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

TU (2)