Serebral Palsili Adölesanlarda Gövde Odaklı Rehabilitasyonun Spinal Mobilite, Gövde Kontrolü Ve El Fonksiyonları Üzerine Etkilerinin İncelenmesi
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Evaluation of Trunk Control
研究概览
简要总结
Main Purpose: This study aims to investigate the effects of trunk-focused rehabilitation on trunk control, spinal mobility, and manual skills in adolescents with cerebral palsy (CP).
Secondary Purpose: To investigate its effects on functional health.
详细描述
Muscle weakness in the trunk; reducing the support of children with CP, may cause increased distal tone and decreased function in their daily practices. When the effectiveness of interventions that can improve postural control is evaluated, trunk-focused training is one of the 5 interventions supported by a moderate level of evidence. In an intervention study where trunk training was structured individually, there may be an improvement in erector spinae muscle group scores when evaluated with sEMG. A study of 28 cases, including all subtypes of CP, aimed to evaluate the inter-rater reliability of Spinal Mouse (SM) and the effect on the spinal column with 4 hours a day, 1 week of intensive clinical rehabilitation application. In this population, SM was evaluated with therapeutic interventions, it has been reported that it may show significant posture differences, especially in total spinal inclination and spine length. In children aged 5-12 years with Gross Motor Function Classification System (GMFCS) Level 1, 2 CP, there are significant improvements in the Trunk Control Measurement Scale (TCMS) score after only Trunk Focused Rehabilitation (TFR). It is emphasized that with TFR, which is described as a unique approach, postural control of the whole body can be improved by the use of intermediate postures and postural activities involving the trunk and better participation of the affected muscles. Only after TFR intervention, the findings of improvement in the assessments on a 3D force platform were highlighted in postural sway, early sternal and sacral decelerations. It is carried out with active participation, individualized, intensive, and time-limited, considering possible content limitations and the needs and preferences of the adolescent and the family. It is stated that trunk-targeted interventions can be given together with conventional physical therapy programs to support functional improvements.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Levels 1 and 2 according to Gross Motor Function Classification System (GMFCS)
- •Viking Speech Scale Turkish version/(VSS-T) 1-2 level, understood to speak and able to take commands
- •Adolescents with CP between the ages of 12-18
- •Those whose guardian / legal representative and themselves have received an Informed Voluntary Consent Form
- •No hip dislocation
- •Scoliosis below 25 degrees according to the radiographic evaluation made in the last 6 months
排除标准
- •Having had any surgery related to the intrathecal baclofen pump
- •Having botulinum toxin injection treatment or orthopedic surgery within the last 6 months
- •Having severe vision, hearing, and cognitive deficiencies
- •Acute medical illness
研究组 & 干预措施
Trunk Focused Rehabilitation (TFR) plus Conventional Rehabilitation (CR) Group
- Abdominal stabilization progression for TFR is applied to all cases with simultaneous breathing exercises for 8 weeks (24 sessions in total) (8). Exercises are performed 3 days a week, 45 minutes a day, starting from warm-up and recumbent position respectively, and the intensity is adjusted individually by observing tone and motivation.
The experimental group's routine physiotherapists also gave them a conventional rehabilitation program (the same protocol as in the active comparison arm) for 40 minutes per day, 2 days per week.
干预措施: Trunk Focused Rehabilitation (TFR) (Other)
Trunk Focused Rehabilitation (TFR) plus Conventional Rehabilitation (CR) Group
- Abdominal stabilization progression for TFR is applied to all cases with simultaneous breathing exercises for 8 weeks (24 sessions in total) (8). Exercises are performed 3 days a week, 45 minutes a day, starting from warm-up and recumbent position respectively, and the intensity is adjusted individually by observing tone and motivation.
The experimental group's routine physiotherapists also gave them a conventional rehabilitation program (the same protocol as in the active comparison arm) for 40 minutes per day, 2 days per week.
干预措施: Conventional Rehabilitation (CR) (Other)
Conventional Rehabilitation (CR) Group
The control group is the group that receives conventional treatment 2 days a week, 40 minutes per session.
Conventional Rehabilitation Program Content: All sessions include the following rehabilitation program, supervised by a physiotherapist and individualized according to tolerance. Number of exercise repetitions: 10-20. The intensity is adjusted by observing motivation.
干预措施: Conventional Rehabilitation (CR) (Other)
结局指标
主要结局
Evaluation of Trunk Control
时间窗: at baseline and week 9
Trunk Impairment Scale: It consists of coordination, dynamic and static sections. In the static section, the responses in actively and passively crossing the legs with the feet in a supported position are recorded. In the dynamic section, unilateral hip movements and lateral flexion of the trunk are evaluated. In the coordination section, the upper and lower body are asked to move. Coordination consists of dynamic and static sections. The maximum scores that can be obtained from the tests are 7 for the static section, 10 for the dynamic section, and 6 for the coordination section. The score range is 0-23. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.
Evaluation of Spinal Mobility
时间窗: at baseline and week 12
Spinal Mobility and Alignment Assessment (Sagittal Plane): Spinal Mouse (SM) measurements are taken at the same time of day, in an environment where the patient is resting, distrubating their weight equally between their two feet as much as possible, and standing symmetrically, while the patient is standing upright in an anatomical position, by moving downwards at a constant speed over the SM spinal criterion points (from C7 spinous process to S3) by the physiotherapist. The spine is measured 3 times in the sagittal plane. The average value of the measurements is used for analysis.
Evaluation of Hand Functions
时间窗: at baseline and week 9
Jebsen Taylor Hand Function Test (JTHFT): Writing, card turning, picking up small objects, large and heavy objects skills and durations are assessed in both hands. 7 items are repeated for both hands. The completion time of each task is recorded separately. The score for the subtest is equal to the time in seconds required to complete the task, the maximum score for the subtest is 120. The total score is equal to the sum of points for all subtests and is calculated separately for each hand. The lower the score, the better the child's hand function.
次要结局
- 1 Minute Walking Test (1-MWT):(at baseline and week 9)
- Pediatric Data Collection Tool (PODCI)(at baseline and week 9)