Examination of the Effects of Video-Based Games on Balance, Trunk Proprioception, Motivation and Quality of Life in Individuals With Cerebral Palsy

March 3, 2024 updated by: İlkan Cicek, Mustafa Kemal University

In the study we planned, 42 individuals diagnosed with cerebral palsy will be divided into 2 groups according to age groups. Individuals aged 4-11 will be included in the child group, and individuals aged 12-18 will be included in the adolescent group. Individuals with cerebral palsy in the child and adolescent group will also be randomized and divided into treatment and control groups. In addition to the conventional treatment created in accordance with neurodevelopmental treatment approaches, video-based virtual reality games will be played for a total of 10 weeks for treatment groups in both age groups. The patients will be followed up with a video-based game application for an average of 20 minutes, after the physiotherapy and rehabilitation application, which consists of an average of 45 minutes, twice a week. Individuals in the control group in both age groups will be followed for 10 weeks with conventional treatment created in accordance with neurodevelopmental treatment approaches.

The entire sample will be evaluated at the beginning of the study and at the end of the 10th week. Our main aim in the study is to compare the effects of video-based games applied in different age groups on balance, trunk proprioception, motivation and quality of life.

Study Overview

Detailed Description

A total of 42 patients with cerebral palsy who agreed to participate in the study, 22 patients between the ages of 4-11 and 22 patients between the ages of 12-18, will be included. Parents of the patients will be informed about the study.

42 individuals diagnosed with cerebral palsy will be divided into 2 groups according to age groups. Individuals aged 4-11 will be included in the child group, and individuals aged 12-18 will be included in the adolescent group. Individuals with cerebral palsy in the child and adolescent group will also be randomized within themselves and divided into treatment and control groups. In addition to conventional treatment created in accordance with neurodevelopmental treatment approaches, video-based virtual reality games will be played for a total of 10 weeks for treatment groups in both age groups. The patients will be followed up with an average of 20 minutes of video-based games, after the physiotherapy and rehabilitation application, consisting of an average of 45 minutes, twice a week. Individuals in the control group in both age groups will be followed for 10 weeks with conventional treatment created in accordance with neurodevelopmental treatment approaches.

A treatment plan will be created for the entire sample group according to neurodevelopmental treatment approaches. In the content of the treatment plan; In order to regulate muscle tone and increase sensory input, intramuscular stretching and soft tissue mobilization, exercises that improve protective, balance and correction reactions, and support the development of postural control will be included. In addition, studies aimed at ensuring proper posture and increasing body awareness during standing without support, facilitation of trunk extension will be carried out. For the development of postural control in the same position, facilitation of trunk elongation and weight transfer to the affected and less affected side will be emphasized. Exercises will be performed on stepping and descending from the affected and less-affected side. Supported with appropriate hand grips, forward jumping with two feet, one foot, and weight transfer on one foot will be carried out.

In the evaluation of the patient, the pediatric motivation scale, balance, trunk proprioceptive sense and quality of life will be evaluated at the 1st and 10th weeks.

Study Type

Interventional

Enrollment (Actual)

42

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

    • Hatay
      • Antakya, Hatay, Turkey, 31000
        • Hatay Mustafa Kemal Üniversitesi

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

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being diagnosed with spastic type CP with bilateral and unilateral involvement Volunteer to participate in the study Be between the ages of 4-18 Being at 1/2 level according to Gross Motor Function Classification System Cooperate with assessments Cooperating with virtual reality therapy

Exclusion Criteria:

  • Botulinum toxin administration in the last 6 months Having had any surgical operation 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group- 4-11 age
Balance and trunk proprioception games will be selected and played for the children to be included in the treatment. Children will play these games with their own body movements.
Bobath therapy
Placebo Comparator: Control Group-4-11 age
Bobath therapy
Experimental: Study Group- 12-18 age
Balance and trunk proprioception games will be selected and played for the children to be included in the treatment. Children will play these games with their own body movements.
Bobath therapy
Placebo Comparator: Control Group-12-18 age
Bobath therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One Leg Standing Test
Time Frame: beginning and week 10
The one-leg stance test is a test in which the time to stand on balance is measured on the right and left extremities of the patient, and evaluates the static balance. Change will be evaluated.
beginning and week 10
Caliper Clinometer
Time Frame: beginning and week 10
Caliper inclinometer is a phone protractor application used to measure angle changes in the relevant region. In the evaluation of trunk proprioception, the person is in a sitting position with the back unsupported and the feet not touching the ground, while the arms are positioned crossed on the trunk. Change will be evaluated
beginning and week 10
Pediatric Motivation Scale
Time Frame: beginning and week 10
The scale consists of 21 items divided into 6 subsections (effort-importance, interest-pleasure, competence, relationship, autonomy, value-benefit) and enables the evaluation of the child's motivation towards the rehabilitation program from her own perspective.The total score is 119. The higher the score, the higher the motivation. Change will be evaluated.
beginning and week 10
Pediatric quality of life questionere pedsQL for Children
Time Frame: beginning and week 10
The Children's Quality of Life Scale was developed to measure the quality of life of children and adolescents aged 2-18.It is scored between 0-100, with the highest score being 100. Change will be evaluated
beginning and week 10

Collaborators and Investigators

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

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)

May 5, 2022

Primary Completion (Actual)

July 5, 2022

Study Completion (Actual)

July 22, 2022

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Actual)

December 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MustafaKU-PTIlkan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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