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临床试验/NCT06073743
NCT06073743已完成不适用

The Effect of Video Based Games Exercise Training on Selective Motor Control, Fear of Falling and Functional Capacity in Individuals With Spastic Cerebral Palsy

Abant Izzet Baysal University2 个研究点 分布在 2 个国家目标入组 26 人开始时间: 2023年12月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Six Minute Walk Test (6MWT)

研究概览

简要总结

Cerebral palsy (CP) is a non-progressive neurological disorder characterized by a persistent decline in sensory, cognitive or especially gross and fine motor functions during infancy or early childhood. In children with spastic CP, spasticity, muscle weakness, delay in motor development, inadequacy of gross and fine motor skills, selective motor control and functional capacity may be affected. Selective motor control (SMC) is the ability to isolate a muscle or muscle group to perform a specific movement. In children with CP, spasticity directly causes impairment of SMC, as movement patterns governed by flexor or extensor synergies are affected, which inhibits functional movements. Motor dysfunction in CP causes activity limitations and can negatively affect functional capacity. In addition, falls may increase in individuals with CP due to poor balance control, resulting in pain, injury and disability, and may cause individuals to lose confidence in their ability to perform routine activities. Increased fear of falling in individuals with CP may also lead to restriction of activities.It was discussed that the interactive computer game has possible evidence of efficacy allowing to improve gross motor function in individuals with CP. It also appears to have the potential to produce gross motor improvements in terms of strength, balance, coordination and gait for individuals with CP.As a result of our literature review, studies investigating the effect of virtual reality games on gait, balance and coordination in children with CP were observed. However, the effect of virtual reality games on selective motor control has not been sufficiently investigated. The aim of our study, which is planned to eliminate this deficiency in the literature, is to investigate the effect of video game-based exercise training, which provides higher motivation than conventional physical therapy methods, on selective motor control, fear of falling and functional capacity in individuals with CP.

详细描述

The effect of Virtual Reality Kinect video games, which provide higher motivation than conventional physical therapy methods, on selective motor control, fear of falling and functional capacity will be examined.

The study will include children with spastic CP between the ages of 6-18 years who are attending a Special Education and Rehabilitation Center and who agree to participate in the study. According to the power analysis based on the reference article, it is planned to include 26 people in the study, 13 in the convention physiotherapy group and 13 in the video game-based exercise group.

The families of the children included in the study will be asked to sign an Informed Consent Form and the children will be asked to sign a Child Consent Form for Research Purposes. Demographic data such as gender, age, type of extremity involvement, age at diagnosis will be recorded before the training. The cognitive level of the individuals will be evaluated with the Mini Mental State test, gross motor levels will be classified according to the Gross Motor Function Classification System and hand skills will be classified according to the Hand Skills Classification System. Selective motor control of the upper extremity will be evaluated with the Selective Control of Upper Extremity Evaluation Scale (SCUES) and selective motor control of the lower extremity will be evaluated with the Selective Control of Lower Extremity Evaluation Scale (SCALE). Individuals' balance skills in daily living activities will be evaluated with the Pediatric Balance Scale, fear of falling will be evaluated with the Pediatric Fear of Falling Scale, and functional capacity will be evaluated with the 6-minute walk test.

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
None

入排标准

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

入选标准

  • 未提供

排除标准

  • Any botulinum toxin application and surgical intervention to the lower and upper extremities in the last 6 months
  • Serious vision and hearing problems
  • Children who have difficulty understanding and following the rules of the game,
  • Receiving surgery or botox application to the lower or upper extremity
  • Individuals with joint contracture
  • Those with pacemakers because they emit radio waves

结局指标

主要结局

Six Minute Walk Test (6MWT)

时间窗: 10 weeks

The 6MWT is a simple, submaximal, clinical exercise test that measures the distance walked in 6 minutes under controlled conditions. The 6MWT has been used in children with cerebral palsy (CP) in recent years. In these populations, the 6MWT is considered a measure of overall 'functional status' as 6MWT performance involves the integrated response of multiple body systems.

Selective Voluntary Motor Control of the Upper Extremities (SCUES)

时间窗: 10 weeks

SCUES is a test that evaluates selective motor control of the upper extremity with a score between 0-3. SCUES assesses the shoulder, elbow, forearm, wrist and fingers bilaterally. Motion at each of the five joint levels is graded on a four-point scale: Normal Selective Motor Control (3 points) M3, Mildly Diminished Selective Motor Control (2 points) M2, Moderately, Diminished Selective Motor Control (1 point) M1, No Selective Motor Control (0 points) M0. Higher scores mean a better outcomes.

Pediatric Fear of Falling Questionnaire

时间窗: 10 weeks

It is a scale that assesses the fear of falling in activities of daily living in the pediatric population. There are 6 main topics. There are a total of 34 items in which children's fear of falling is questioned during different activities. Participants receive a score between 0 and 68, with higher scores indicating higher fear of falling.

Selective Control Assessment of the Lower Extremity (SCALE)

时间窗: 10 weeks

It is a test that evaluates the selective motor control of the lower extremity with a score between 0 and 2. It evaluates the hip, knee, ankle and toe joints bilaterally.Scoring is graded at each joint as 'Normal' (2 points), 'Impaired' (1 point), or 'Unable' (0 points).Higher scores mean a better outcomes.

次要结局

  • Pediatric Balance Scale (PBS)(10 weeks)
  • Gross Motor Classification System (GMFCS)(Baseline)
  • Modified Mini Mental Test (MMMT)(Baseline)
  • Manual Ability Classification System (MACS)(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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