Effects of Intensive Neurophysiological Rehabilitation System in Children With Cerebral Palsy: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in Gross Motor Function Measure score (GMFM-66)
研究概览
简要总结
Evaluation of effects of Intensive Neurophysiological Rehabilitation System in children with cerebral palsy in a single-blinded randomized controlled trial with two groups.
详细描述
Intensive Neurophysiologic Rehabilitation System (INRS) is an intensive multimodal rehabilitation system, whereby versatile and multi-faceted methods are combined with the aim of improvement of functioning and quality of life of children with CP. Treatment components are addressing different functional goals in the Body Functions domain of the International Classification of Functioning (joint mobility, muscle tone, voluntary movement, pain, intellectual functions) and Activities and Participation domains (fine hand use, walking, moving around, interpersonal interactions and family relationships.
The Intensive correction course includes up to four hours of daily training. The treatment program is tailored individually according to the patient's condition and incorporates some of the following component according to individual indications and contraindications: Physical therapy, Occupational therapy, Full body massage, Spinal manipulative therapy, Joint mobilization techniques, Paraffin and wax applications, Reflexotherapy, Strength training, Computer game therapy, Suit therapy, Vibration therapy, Treadmill training, Group session of "rhythmic gymnastics". The influence of one technique complements and potentiates other rehabilitation components.
The aim of the study is to evaluate effects of Intensive Neurophysiological Rehabilitation System in children with cerebral palsy in a randomized controlled trial.
A single-blinded randomized controlled trial with two groups will be conducted. The experimental group will undergo treatment course according to INRS, control group will continue receive usual home activity and care while staying on the waiting list. To avoid possible information leak about patient group allocation, the study should be performed in two independent centers: Evaluation center and Treatment center. Assessments will be conducted three times: at the baseline, in 3 weeks, and 7 weeks after the baseline.
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 (Care Provider, 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
- •Cerebral Palsy bilateral spastic forms,
- •Age 4-12 years,
- •Gross Motor Function Classification System - Levels I-IV,
- •Manual Ability Classification System - Levels I-IV.
排除标准
- •Uncontrolled epileptic syndrome,
- •Severe intellectual disability,
- •Uncooperative behavior,
- •Surgery during ongoing year.
结局指标
主要结局
Change in Gross Motor Function Measure score (GMFM-66)
时间窗: Baseline, 3-week, and 7-week follow-up
The Gross Motor Function Measure (GMFM) evaluates gross motor function in children with cerebral palsy. The GMFM-66 version contains 66 items that span the spectrum from activities as lying and rolling up to walking, running, and jumping skills.
次要结局
- Change in Daily functioning- Self-Care(Baseline, 3-week, and 7-week follow-up)
- Change in Jebsen-Taylor hand function score(Baseline, 3-week, and 7-week follow-up)
- Change in Manual dexterity(Baseline, 3-week, and 7-week follow-up)
- Change in Daily functioning- Mobility(Baseline, 3-week, and 7-week follow-up)
- Change in ABILHAND-Kids score(Baseline, 3-week, and 7-week follow-up)
- Change in passive range of ankle dorsiflexion(Baseline, 3-week, and 7-week follow-up)
研究者
Oleh Kachmar
Head of Innovative Techologies department
International Clinic of Rehabilitation, Ukraine