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临床试验 NCT07253857 (HABIT-ILE) 针对脑瘫，痉挛性脑瘫目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity in Spastic Cerebral Palsy (HABIT-ILE) 42 随机化 儿科
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临床试验NCT07253857 (HABIT-ILE)是一项针对脑瘫，痉挛性脑瘫的干预性研究试验，目前试验状态为招募中。试验始于2025年12月20日，计划招募42名患者。该研究由Lahore University of Biological and Applied Sciences主导，预计于2026年5月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年1月13日。
简要概括
Cerebral palsy (CP), particularly the spastic diplegic subtype, is characterized by motor impairments such as spasticity and mobility limitations. In addition to motor dysfunction, children with CP often experience cognitive impairments affecting decision-making, problem-solving, working memory, selective attention, and inhibitory control. These non-motor challenges contribute to reduced social interaction and qualit...显示更多
详细描述
Cerebral palsy is a group of permanent movement and posture disorder caused by damage to the developing brain typically before, during or after birth. It is one of the most common neurodevelopmental disorder in childhood. Spasticity accounts for the majority of cases (around 92%), followed by dyskinesia, hypotonia, ataxia, and mixed types. Within spastic CP, three subtypes are recognized: diplegia, quadriplegia, and ...显示更多
官方标题
Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity on Motor Function and Cognition in Children With Spastic Cerebral Palsy
疾病
脑瘫痉挛性脑瘫出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- HABIT-ILE
- UBAS/ERB/FoRS/25/039 Aleena
NCT编号
实际开始日期
2025-12-20
最近更新发布
2026-01-13
预计完成日期
2026-05
计划入组人数
42
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
HABIT-ILE
Intensive motor therapy
Cerebral Palsy
diplegic cerebral palsy with spasticity
Spastic cerebral palsy
Intensive motor therapy
Cerebral Palsy
diplegic cerebral palsy with spasticity
Spastic cerebral palsy
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性GROUP -A HABIT-ILE Therapy Name of intervention : Hand and Arm Bimanual Intensive Therapy Including Lower Extermity Type of intensity; intensive , activity based camp style rehabilitation program The HABIT-ILE therapy sessions will be structured to target both upper and lower limbs divided into three categories. Half of each session will focus on table-based bimanual tasks with postural challenges, performed while sitting on fitness balls or s...显示更多 | GROUP -A , Hand and Arm Bimanual Intensive Therapy Including Lower Extremity Hand Arm Bimanual Intensive Therapy Including Lower Extremity being a task based intensive therapy activities will be structured according to the participants ability to preform it. The intervention incorporates structured bimanual activities that progressively increase in motor complexity, along with functional tasks that necessitate coordinated use of both hands, systematically integrating postural and lower-extrem...显示更多 |
实验性GROUP- B Conventional Physical Therapy The intervention will be delivered five times per week, with each movement repeated three to five times. Sessions will begin at low to moderate intensity and will gradually progress based on patient response. Exercises will include weight-bearing activities such as sit-to-stand transitions to strengthen quadriceps and gluteal muscles, step initiation drills to activate tibialis anterior and gastrocnemius for proper f...显示更多 | GROUP-B , Conventional Physical Therapy Conventional therapy will include stretches of lower extremity following bobath approach and cognitive exercises. |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Gross Motor Function Measure 88 (GMFM-88) | It is a standardized assessment tool designed to evaluate motor function in children with cerebral palsy (CP). It consists of 88 items that measure gross motor abilities across five domains: lying \& rolling, sitting, crawling \& kneeling, standing, and walking, running \& jumping. Each domain is scored on a 4-point ordinal scale where 0 indicates the child does not initiate the movement, 1 reflects initiation with less than 10% completion, 2 represents partial completion between 10% and less than 100%, and 3 denotes full completion of the movement as intended. Higher scores means that the child can move more independently while lower scores show difficulties in movement and point to areas where therapy is needed. | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
Behavior Rating Inventory Of Executive Function-2 (BRIEF-2) Parent form | It assesses executive function in children, including those with cerebral palsy (CP), measuring impulse control, emotional regulation, and working memory | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
ABILOCO-KIDS-CP | This assessment tool designed to evaluate locomotion ability in children with cerebral palsy | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
ABILHAND-KIDS-CP | it is an assessment tool designed to evaluate manual ability in children with cerebral palsy. It focuses on bimanual activities, measuring the child's ability to perform daily tasks requiring upper limb coordination. | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
Box and Block Test (BBT) | It is assessment tool for evaluating manual dexterity in individuals with cerebral palsy. It measures gross motor coordination of the upper limbs by assessing the ability to grasp, transport, and release small blocks within a timed period. | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
6 Minute Walk Test | It evaluates how far a person can walk in six minutes | Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9 |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
6 Years
适龄性别
全部
- Diagnosed with diplegic cerebral palsy
- CP children with manual ability level 1-3 on manual ability classification system
- Participants with gross motor function classification system level ranging from 1-3 will be included in the study.
- With an ability to grasp light objects and lift the more affected arm 15 cm above a table surface.
- Base line cognition level should be 20 or above assessed through mini mental state exam for children (MMC).
- Uncontrolled seizures
- Recent or planned botulinum toxin injections within 6 months
- Any recent orthopedic interventions that may affect motor function
- Visual impairments impeding with treatment protocol
Lahore University of Biological and Applied Sciences研究中心联系人
联系人: Aleena Ishfaq, DPT, +92 3324210141, [email protected]
联系人: Aruba Saeed, NMPT, PhD*, +92 3344399403, [email protected]
1 位于 1 个国家/地区的研究中心
Punjab Province
Pakistan Society for Rehabilitation of Differently Abled (PSRD), Lahore, Punjab Province, 54660, Pakistan
招募中