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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05667792
Other study ID # MustafaKU-PTIlkan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 5, 2022
Est. completion date July 22, 2022

Study information

Verified date March 2024
Source Mustafa Kemal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date July 22, 2022
Est. primary completion date July 5, 2022
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Microsoft Kinect 360
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.
Other:
Pediatric Rehabilitation
Bobath therapy

Locations

Country Name City State
Turkey Hatay Mustafa Kemal Üniversitesi Antakya Hatay

Sponsors (1)

Lead Sponsor Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary One Leg Standing Test 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
Primary Caliper Clinometer 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
Primary Pediatric Motivation Scale 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
Primary Pediatric quality of life questionere pedsQL for Children 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
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