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临床试验 NCT07487857 (CAMPUSENS) 针对脑瘫目前尚未招募。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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Intensive Somatosensory Camp for Manual Function and Participation in Children With Unilateral Cerebral Palsy (CAMPUSENS) 26
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临床试验NCT07487857 (CAMPUSENS)是一项针对脑瘫的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年6月20日开始，预计招募26名患者。该研究由University of Castilla-La Mancha主导，计划于2026年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月23日。
简要概括
This study will evaluate whether an intensive day camp that combines somatosensory and motor training for the affected upper limb improves hand function and participation in children with unilateral cerebral palsy more than an intensive motor-only camp of equal duration and intensity. Children aged 5 to 15 years with unilateral spastic cerebral palsy and Manual Ability Classification System (MACS) levels I-III will b...显示更多
详细描述
Unilateral cerebral palsy is a common cause of motor disability in childhood and is frequently associated with somatosensory impairments of the affected upper limb, such as reduced tactile discrimination, impaired proprioception and difficulties with object recognition by touch. These sensory deficits contribute to learned non-use of the affected hand and limited spontaneous bimanual performance in daily activities, ...显示更多
官方标题
Intensive Somatosensory Camp for Manual Function and Participation in Children With Unilateral Cerebral Palsy: a Randomnized Controlled Trial
疾病
脑瘫其他研究标识符
- CAMPUSENS
NCT编号
实际开始日期
2026-06-20
最近更新发布
2026-03-23
预计完成日期
2026-12-31
计划入组人数
26
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
unilateral cerebral palsy
hemiparesis
upper limb function
somatosensory training
intensive rehabilitation
bimanual performance
pediatric
rehabilitation
hemiparesis
upper limb function
somatosensory training
intensive rehabilitation
bimanual performance
pediatric
rehabilitation
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
双盲
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Experimental: Somatosensory-Motor Intensive Camp 8-day intensive day camp (40 hours total, 5 hours/day) for children with unilateral cerebral palsy. Combines structured somatosensory training (tactile discrimination, texture exploration, vibration stimulation, proprioception, vestibular input) integrated within functional upper limb motor tasks, play-based workshops, and balance activities targeting bimanual hand function and participation. | Motor-Only Intensive Camp Structured 8-day intensive rehabilitation camp (40 hours total, 5 hours/day) focused exclusively on upper limb motor training for children with unilateral cerebral palsy. Includes active range of motion exercises, grip strength training, fine motor coordination tasks (grasping, threading, block manipulation), reaching/coordination circuits without structured somatosensory stimulation. |
阳性对照Active Comparator: Motor Camp 8-day intensive day camp (40 hours total, 5 hours/day) focused exclusively on upper limb motor training for children with unilateral cerebral palsy. Includes active range of motion exercises, strength training, coordination circuits, grasping/manipulation tasks, and fine motor activities without structured somatosensory stimulation | Somatosensory-Motor Intensive Camp Structured 8-day intensive rehabilitation camp (40 hours total, 5 hours/day) for children with unilateral cerebral palsy. Integrates somatosensory stimulation (tactile massage, texture discrimination, vibration therapy, proprioceptive exercises, vestibular/balance activities) within functional upper limb motor tasks, play-based workshops, and bimanual activities targeting spontaneous hand use and participation in dai...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Assisting Hand Assessment (AHA) | Change in spontaneous bimanual hand use of the affected upper limb in children with unilateral cerebral palsy, measured by the Assisting Hand Assessment (AHA). The AHA is a video-based, criterion-referenced measure of how effectively a child with a unilateral hand impairment spontaneously uses their affected hand during bimanual play activities. Scores range from 0-100 (higher scores indicate better bimanual performance). | Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Melbourne Assessment of Unilateral Upper Limb Function Version 2 (MA-2) | Quality of unilateral upper limb movement (range of motion, accuracy, dexterity, fluency) in children with unilateral cerebral palsy, measured by video analysis using MA-2 standardized criteria. | Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2) |
Somatosensory Function (SWM, 2PD, Stereognosis) | Tactile discrimination and somatosensory function of the affected hand measured by Semmes-Weinstein Monofilaments (SWM) for touch threshold, two-point discrimination (static/dynamic), localization, double simultaneous stimulation, and stereognosis (object recognition by touch). | Baseline (T0), immediately after intervention (T1, 8 days), follow-up at one month (T2) |
Hand Grip Strength (Jamar Dynamometer) | Maximum cylindrical grip strength (kg) of affected and non-affected hands, measured in standardized sitting position with 3 trials per hand using Jamar hydraulic dynamometer. | Baseline (T0), immediately after intervention (T1, 8 days), follow-up at one month (T2) |
Upper Limb Activity (Wrist Accelerometry) | Objective measurement of spontaneous upper limb movement quantity and intensity using wrist-worn accelerometers on both wrists during AHA assessment and daily life outside camp. | Baseline (T0), during daily life in camps days, immediately after intervention (T1, 8 days), follow-up at one month (T2) |
Participation (COPM, PEM-CY) | Family-identified functional priorities and participation in daily activities measured by Canadian Occupational Performance Measure (COPM) performance/satisfaction scores and Participation Environmental Measure-Children and Youth (PEM-CY) frequency/involvement dimensions in school, home and community. | Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2) |
GMFM-66 (Gross Motor Function Measure-66 Item Set) | It is a validated observational instrument that assesses changes in gross motor function in children with cerebral palsy from 5 months to 16 years of age. It consists of 66 items grouped into five dimensions (supine/rolled over, sitting, crawling/kneeling, standing/walking). Scoring is expressed as a percentage (0-100). The Item Set groups the items according to age and the corresponding GMFCS level, thus shortening the assessment and eliminating the need to examine all 66 items of the original GMFM-66. The score is then calculated using the GMAE software. | Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2) |
Pediatric Balance Scale (PBS) | This is a modified version of the Berg Balance Scale for school-aged children (4-15 years) with mild-to-moderate motor disabilities. It assesses 14 functional static/dynamic balance tasks (sitting, standing, reaching, turning). Each item is scored from 0-4 (maximum total 56). It will be used up to age 8 in this study. | Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2) |
Trunk Control Measurement Scale (TCMS-S) | It is used to measure trunk control during functional activities in a seated position. It provides a structured and quantitative assessment of how a person controls their trunk both statically and in motion, including balance, selective trunk movements, and dynamic reach beyond the base of support. It is validated for individuals with neuromotor impairment aged 5 to 19 years. | Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2) |
Children's Hand-use Experience Questionnaire (CHEQ | This is an online questionnaire completed by parents and/or the child that assesses the perception of hand use during different bimanual activities. It has two versions: the mini-CHEQ for children aged 3-8 years and the CHEQ for children aged 6-18 years. The questionnaire is completed by parents for children under 13 years of age. For children over 13 years of age, both parents and children complete it. It takes 20-30 minutes to complete. | Baseline (T0), immediately after intervention (T1, 8 days) |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
5 Years
适龄性别
全部
- diagnosis of spastic CP
- aged between 5 and 15 years of age
- able to follow simple verbal instructions and complete all the necessary tests according to their ages
- MACS level I-III
- uncontrolled epilepsy episodes in the 6 months prior to the start of the study
- botulinum toxin in the last 6 months
- orthopedic or neurological surgery in the 12 months prior to the start of the study or scheduled during the intervention development period
- visual or cognitive disabilities that interfere with treatment
- unable to actively participate in the activities
University of Castilla-La Mancha研究中心联系人
联系人: Rocío Palomo Carrión PhD, 926051821, [email protected]
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