Video-game Based Therapy in Cerebral Palsy

April 17, 2024 updated by: Demet GÖZAÇAN KARABULUT, Gaziantep Islam Science and Technology University

Effects of Video-game Based Therapy on Upper Extremity Selective Motor Control and Proprioception in Cerebral Palsy

The video-based therapy applications; will be applied in a non-three-dimensional (with desktop screen) way. In this application, there are different types of exercise programs that will work the upper extremity movements. The video-based therapy applications will be applied to individuals with Cerebral Palsy (CP) who will be included in the study with the Xbox Kinect 3600 (Microsoft, Washington, USA) device.

This study was planned to examine the effect of video-based therapy on upper extremity selective motor control and proprioception in individuals with Cerebral Palsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Spastic CP will be participate the study between the ages of 4 and 18 years. Children's classified with GMFCS and MACS. The eligible participants will be allocated two groups, including video-game based therapy group and conventional physiotherapy control group. All the assessments will be performed before and after the therapy in the 8-week therapy groups.The control group individuals will be given a conventional physiotherapy two days per week for a total of 8 weeks (conventional physiotherapy session will last 45 minutes). The video-game based therapy group will receive a conventional physiotherapy and video-game based therapy, two days a week for a total of 8 weeks (15 minutes conventional physiotherapy session+30 minutes video-game based therapy). All sessions will be performed in the clinic with the specialist physiotherapist.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • None Selected
      • Gaziantep, None Selected, Turkey, 27010
        • Demet Gözaçan Karabulut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of Cerebral Palsy voluntary participation,
  • Age between 4-18 years
  • GMFCS Level I-II-III
  • MACS Level I-II-III

Exclusion Criteria:

  • Not voluntary to participate in the research,
  • Botox in the last 6 months,
  • Upper limb or spine surgeries in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video-game based therapy group
The video-game based therapy group will receive a conventional physiotherapy and video-game based therapy, two days a week for a total of 8 weeks (15 minutes conventional physiotherapy session+30 minutes video-game based therapy).
Other: Video-game based therapy
Video-game based therapy will be designed for the individual basis for the upper extremity.
Other: Conventional physiotherapy
Conventional physiotherapy within a specific program
Active Comparator: Conventional physiotherapy group
The conventional physiotherapy group individuals will be given a conventional physiotherapy two days per week for a total of 8 weeks (conventional physiotherapy session will last 45 minutes).
Other: Conventional physiotherapy
Conventional physiotherapy within a specific program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function Classification System (GMFCS)
Time Frame: At Baseline
Assessing functional level and motor function. Gross motor functions of children with CP are classified in five levels with GMFCS. This is a classification system based on the child's self-initiated movements with emphasis on sitting, displacement and mobility.
At Baseline
Manuel ability classification system (MACS)
Time Frame: At Baseline
This is a classification system based on the grasping and releasing objects in daily life, and how they use their hands while holding objects. It is classify the hand skills of children with CP between the ages of 4-18.Children with CP are classified in five levels with MACS. The higher level indicates worse hand function
At Baseline
Change from Baseline Selective Control of the Upper Extremity Scale (SCUES) at 8 weeks
Time Frame: Change from Baseline at 8 weeks
It is a practical and useful assessment tool developed to evaluate upper extremity selective motor control. The administration of the SCUES required patients to perform specific isolated movement patterns at various levels including: shoulder (abduction/adduction); elbow (flexion/extension); forearm (supination/pronation); wrist (flexion/extension); and fingers/thumb (grasp/release). The total score of the SCUES ranges between 0 and 15 and higher scores indicate better selective motor control.
Change from Baseline at 8 weeks
Change from Baseline Clinometer at 8 weeks
Time Frame: Change from Baseline at 8 weeks
Caliper clinometer (App Development) is a phone application used to measure angle changes in the relevant region. In the evaluation of shoulder and elbow proprioception change will be evaluated.
Change from Baseline at 8 weeks
Change from Baseline Entertainment Scale at 8 weeks
Time Frame: Change from Baseline at 8 weeks
The entertainment level of sessions and therapy training for individuals will be evaluated with a 0-10 point numerical rating scale (entertainment scale). There are numbers from 0 to 10 on the horizontal line of 10 cm. 0 "Not fun" on the line in the scale; 10 represents "a lot of fun". Entertainment rating will be recorded numerically from 0 to 10.
Change from Baseline at 8 weeks
Change from Baseline ABILHAND-Kids at 8 weeks
Time Frame: Change from Baseline at 8 weeks
Abilhand Kids evaluates manual ability in children with upper extremity disorders. It consists of 21 items and confirmed in CP. The lowest score that can be obtained from the scale is 0 and the highest score is 42. It can be stated that higher scores correspond to more difficulty in activities.
Change from Baseline at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziantep Islam Science and Technology University

Investigators

  • Study Director: Demet GÖZAÇAN KARABULUT, Gaziantep Islam Science and Technology University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2023

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 15, 2023

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIBTU-FTR-DGK-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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