Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks
研究概览
简要总结
The main objective:
To determine the effectiveness of a treatment that combines the application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy versus a home-based program of specific tasks in improving structure and function, activity and participation.
Hypothesis:
The application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy results in a greater improvement in structure and function, activity and participation compared to the implementation of a home-based specific task program.
详细描述
Randomized clinical trial with blinding of the evaluator and the person analyzing the data.
A home-based protocol of specific tasks will be performed in both groups and one of the groups will also receive a treatment with upper limb splinting. The assessment will be made by a single evaluator with 10 years of experience in the treatment of children with motor disabilities.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of unilateral cerebral palsy (hemiplegia-hemiparesis).
- •Ages between 5 and 12 years.
- •Levels I-III of the Manual Ability Classification System (MACS)
- •Levels I-III of the Gross Motor Function Classification System (GMFCS)
- •Able to understand and respond to verbal instructions.
排除标准
- •Cognitive impairment identified by the school report.
- •Hand orthopedic surgery in the last 6 months.
- •Neuropharmacological intervention in the last 6 months.
- •Allergy to upper limb orthosis material.
- •Affectation of the manual function not due to the neurological condition (trauma, burn ...).
- •Current treatments not compatible with the study.
- •Other significant neurological affections (crisis, severe visual impairment ...).
研究组 & 干预措施
Intervention group
Upper-limb splint and home-based protocol in specific tasks
干预措施: Home-based protocol in specific tasks (Device)
Intervention group
Upper-limb splint and home-based protocol in specific tasks
干预措施: Upper-limb splint (Device)
Control group
Home-based protocol in specific tasks
干预措施: Home-based protocol in specific tasks (Device)
结局指标
主要结局
Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks
时间窗: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Activity measurement: Assisting Hand Assessment. Measurement of bimanual performance in pre-established tasks. It quantifies the effectiveness with which the child uses his affected hand in bimanual activities.
Primary Outcome_2. Change from baseline Children's Hand-use Experience Questionnaire measure. Measurement of bimanual performance in activities of daily living.
时间窗: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Participation and activity measurement: Children's Hand-use Experience Questionnaire. The objective of the questionnaire is to measure bimanual performance in activities of daily living.
次要结局
- Secondary Outcome_4. Change from baseline Neurological Hand Deformity Classification. This tool classify the deformity levels of wrist and fingers.(Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).)
- Secondary Outcome_5. Change from baseline Grip and Pinch Strength measure. Measurement of pinch, wrist and foream strength.(Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).)
- Secondary Outcome_Change from baseline Box and Blocks Test measure. Measurement of unilateral gross manual dexterity.(Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).)
- Secondary Outcome_2. Change from baseline Jebsen Hand Function Test measure. Measurement of a broad range of uni-manual hand functions required for activities of daily living.(Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).)
- Secondary Outcome_3. Change from baseline House Thumb in Palm Deformity Classification. Classify the deformity level of thumb.(Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).)