Evaluation of "Intensive Neurophysiological Rehabilitation System" (INRS) With "Biomechanical Correction of the Spine According to Kozyavkin" (BCSK) in Children With Spastic Bilateral Cerebral Palsy: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Gross Motor Function Measure 66 (GMFM 66) is used to measure change over time
研究概览
简要总结
A randomized control trial investigating "Biomechanical Correction of the Spine according to Kozyavkin" (BCSK) which is a part of the treatment concept "Intensive Neurophysiological Rehabilitation System" (INRS). BCSK is used with the aims to reduce muscle tone and improve gross and fine motor function in children with Spastic Bilateral Cerebral Palsy.
详细描述
The study is a collaboration between the International Clinic of Rehabilitation (ICR) in Ukraine and the Karolinska Institute (KI) in Sweden. The intervention and the assessments are performed at ICR. The primary outcome measure, evaluation of gross motor function with the test GMFM 66 is filmed and the recordings are transferred to KI together with all assessment data. KI are responsible for study research design and collects, analyzes and processes all data. It is a double blinded study. Only two persons will know to which group the subject belongs, the person performing the randomization process in Sweden and the doctor performing the spinal corrections.
There are two aims of the study;
- To evaluate the effect of "Biomechanical Correction of the Spine" (BCSK) in children with Spastic Bilateral Cerebral Palsy.
- To evaluate the effect of "Intensive Neurophysiological Rehabilitation System" (INRS) in children with Spastic Bilateral Cerebral Palsy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Other forms of Cerebral Palsy
- •Severe epileptic syndrome
- •Severe mental retardation
- •Orthopedic surgery within the last year
研究组 & 干预措施
INRS with BCSK
"Intensive Neurophysiological Rehabilitation System (INRS)" including the "Biomechanical correction of the spine according to Kozyavkin (BCSK)".
The daily treatment for about 2 hours are in general equal for all children except for the type of spinal manipulation. Duration of all treatment will be noted in a Treatment Diary.
干预措施: BCSK (Procedure)
Total population
All participants (i.e., both arms described above INRS with BCSK or traditional spinal manipulation)
干预措施: BCSK (Procedure)
Total population
All participants (i.e., both arms described above INRS with BCSK or traditional spinal manipulation)
干预措施: Traditional spinal manipulation (Procedure)
Total population
All participants (i.e., both arms described above INRS with BCSK or traditional spinal manipulation)
干预措施: INRS (Procedure)
INRS with BCSK
"Intensive Neurophysiological Rehabilitation System (INRS)" including the "Biomechanical correction of the spine according to Kozyavkin (BCSK)".
The daily treatment for about 2 hours are in general equal for all children except for the type of spinal manipulation. Duration of all treatment will be noted in a Treatment Diary.
干预措施: INRS (Procedure)
INRS with traditional spinal manipulation
"Intensive Neurophysiological Rehabilitation System (INRS)" including spinal manipulation by the traditional technique.
The daily treatment for about 2 hours are in general equal for all children except for the type of spinal manipulation. Duration of all treatment will be noted in a Treatment Diary.
干预措施: Traditional spinal manipulation (Procedure)
INRS with traditional spinal manipulation
"Intensive Neurophysiological Rehabilitation System (INRS)" including spinal manipulation by the traditional technique.
The daily treatment for about 2 hours are in general equal for all children except for the type of spinal manipulation. Duration of all treatment will be noted in a Treatment Diary.
干预措施: INRS (Procedure)
结局指标
主要结局
Gross Motor Function Measure 66 (GMFM 66) is used to measure change over time
时间窗: Baseline, 2 weeks, 6 months
The Gross Motor Function Measure (GMFM) evaluates gross motor function in children with cerebral palsy. This version, GMFM 66, contains 66 items that span the spectrum from activities in lying and rolling up to walking, running and jumping skills.
次要结局
- Muscle tone testing using Modified Ashworth Scale is used to measure change over time(Baseline, 2 weeks, 6 months)
研究者
Hans Forssberg
Professor
Karolinska Institutet