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临床试验/NCT05667792
NCT05667792已完成不适用

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

Mustafa Kemal University2 个研究点 分布在 2 个国家目标入组 42 人开始时间: 2022年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
One Leg Standing Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Control Group-12-18 age

Placebo Comparator

干预措施: Pediatric Rehabilitation (Other)

Study Group- 4-11 age

Experimental

干预措施: Microsoft Kinect 360 (Device)

Study Group- 4-11 age

Experimental

干预措施: Pediatric Rehabilitation (Other)

Control Group-4-11 age

Placebo Comparator

干预措施: Pediatric Rehabilitation (Other)

Study Group- 12-18 age

Experimental

干预措施: Microsoft Kinect 360 (Device)

Study Group- 12-18 age

Experimental

干预措施: Pediatric Rehabilitation (Other)

结局指标

主要结局

One Leg Standing Test

时间窗: 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.

Caliper Clinometer

时间窗: 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

Pediatric quality of life questionere pedsQL for Children

时间窗: 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

Pediatric Motivation Scale

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İlkan Cicek

Postgraduate

Mustafa Kemal University

研究点 (2)

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