Comparing the Effects of Modified Constraint-Induced Movement Therapy and Bimanual Training in Children With Hemiplegic Cerebral Palsy Mainstreamed in Regular School: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change from baseline in manual ability on ABILHAND-Kids at 16 weeks
研究概览
简要总结
This study aimed to compare the effects of Modified Constraint-Induced Movement Therapy (mCIMT) and Bimanual Training (BIT) based on the International Classification of Functioning, Disability, and Health, Children &Youth (ICF-CY) conceptual framework. Our assumptions were that (1) mCIMT is more effective on outcomes representing all subdomains of ICF and (2) the possible improvements in the body structure and function, activity, and participation subdomains of ICF are intimately related to each other.
详细描述
Thirty-two children with spastic hemiplegic cerebral palsy (mean age 10.43 years [SD 2.9 years]; 15 females, 17 males) whose functional profiles associated with Manual Ability Classification System, Gross Motor Function Classification System, and Communication Function Classification System changed between level I-III were randomly distributed to one of the mCIMT or BIT groups with equivalent dosing frequency and intensity (10 weeks/3 days per week/2.5 hours per day). Outcome measures categorized according to the domains of International Classification of Functioning, Disability, and Health, Children &Youth (ICF-CY) framework were used to document body functions, activity, and participation outcomes. Assessments were carried out before (T1) and after treatment (T2), and at 16 weeks post-intervention (T3) by a physical therapist blinded to group allocation. Before the study entry, informed consent was obtained from the parents. General and specific contents related to each intervention were delivered as individual sessions at the school (one session per week) or group sessions with two participants at rehabilitation centers (two sessions per week).
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, Outcomes Assessor)
盲法说明
Outcomes assessor was masked to group allocation/ participants were blinded to the presence of two different intervention approaches
入排标准
- 年龄范围
- 7 Years 至 14 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of spastic hemiplegic cerebral palsy
- •Must be able to attend primary or secondary school
排除标准
- •Family-dependent problems interfering with participation in study sessions
- •The presence of behavioral problems interfering with the assessment periods or intervention sessions
结局指标
主要结局
Change from baseline in manual ability on ABILHAND-Kids at 16 weeks
时间窗: Baseline and week 16
ABILHAND-Kids is developed for children with cerebral palsy and measures a child's ability to manage 21 daily activities that require the use of the upper limbs. It measures the children's typical performance in daily life. ABILHAND-Kids is useful in reporting the functional performance of children with one affected side in the perspective of manual ability and has excellent test-retest reliability for Turkish children with cerebral palsy (ICC=0. 0.98)
Change from baseline in unimanual capacity on Upper Extremity Skills Test (QUEST) at 16 weeks
时间窗: Baseline and week 16
The Upper Extremity Skills Test (QUEST) is a criterion-referenced measurement tool, developed to evaluate upper extremity quality of movement in children with cerebral palsy.The Upper Extremity Skills Test has been validated for children with cerebral palsy aged 18 months to 12 years. Intra-rater reliability of the QUEST has been indicated to strong (ICC=0.96) in children with cerebral palsy aged eight and over.
次要结局
未报告次要终点
研究者
Hasan Bingöl
Academician (Lecturer
Muş Alparlan University
