跳至主要内容
临床试验/NCT07487857
NCT07487857尚未招募不适用

Intensive Somatosensory Camp for Manual Function and Participation in Children With Unilateral Cerebral Palsy: a Randomnized Controlled Trial

University of Castilla-La Mancha0 个研究点目标入组 26 人开始时间: 2026年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
26
主要终点
Assisting Hand Assessment (AHA)

研究概览

简要总结

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 be randomly assigned to one of two intervention groups. The experimental group will receive an 8-day, 40-hour camp including structured tactile, proprioceptive and vestibular stimulation integrated into meaningful functional tasks for the upper limb. The control group will receive an 8-day, 40-hour camp focused exclusively on intensive motor training without specific somatosensory stimulation.

The primary outcome is the change in spontaneous bimanual performance of the affected hand, measured with the Assisting Hand Assessment (AHA). Secondary outcomes include measures of unilateral upper limb function, somatosensory function, hand grip strength, gross motor function, balance, trunk control, participation in daily activities and objective upper limb activity measured with wrist-worn accelerometers. Outcomes will be assessed at baseline, immediately after the intervention, and at follow-up visits approximately 2 and 3 months after the camp.

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, even when basic motor abilities are present. Intensive upper limb therapies, such as constraint-induced movement therapy and bimanual training, have shown positive effects on hand function, but most programs focus primarily on motor components and do not systematically target somatosensory function.

This randomized, controlled, single-blind clinical trial will compare two parallel intensive day-camp interventions for children with unilateral spastic cerebral palsy. Both groups will receive 40 hours of therapy over 8 consecutive days (5 hours per day) in a group-based camp format. The experimental group will participate in a structured somatosensory-motor program that integrates tactile, proprioceptive and vestibular stimulation within play-based, goal-oriented upper limb activities and functional workshops. Daily sessions include sensory activation (e.g., tactile massage, exploration of different textures), intensive tactile discrimination and haptic tasks (e.g., object recognition without vision, graded textures, vibration), and integration of somatosensory input into functional tasks and postural control activities (e.g., balance exercises on unstable surfaces, tasks with light weights).

The control group will receive an intensive motor-focused camp with the same total dose, schedule and therapist supervision. Activities will target active range of motion, strength, coordination, and functional use of the affected upper limb through standard manual tasks (such as reaching, grasping, building with blocks, threading, and fine motor games) and gross motor upper limb exercises and circuits, without structured somatosensory stimulation.

The primary objective is to determine whether the somatosensory-motor camp produces greater improvements in spontaneous bimanual performance of the affected hand, assessed by the Assisting Hand Assessment (AHA), compared with the motor-only camp. Secondary objectives include examining changes in unilateral upper limb movement quality (e.g., Melbourne Assessment of Unilateral Upper Limb Function), detailed somatosensory function (e.g., standardized assessments of tactile perception, two-point discrimination, proprioception and stereognosis), grip strength, gross motor function and balance, trunk control, participation and goal attainment, as well as objective upper limb activity recorded by wrist accelerometry in and outside the camp setting. Assessments will be conducted at baseline (T0), immediately after the intervention (T1, after 8 days) and at follow-up visits approximately 2 and 3 months after the camp.

The study is designed as a minimal-risk pediatric rehabilitation trial and follows ethical and data protection regulations. Randomization will be centralized, and outcome assessors and data analysts will be blinded to group allocation.

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 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Assisting Hand Assessment (AHA)

时间窗: Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)

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).

次要结局

  • Melbourne Assessment of Unilateral Upper Limb Function Version 2 (MA-2)(Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2))
  • Somatosensory Function (SWM, 2PD, Stereognosis)(Baseline (T0), immediately after intervention (T1, 8 days), follow-up at one month (T2))
  • Hand Grip Strength (Jamar Dynamometer)(Baseline (T0), immediately after intervention (T1, 8 days), follow-up at one month (T2))
  • Upper Limb Activity (Wrist Accelerometry)(Baseline (T0), during daily life in camps days, immediately after intervention (T1, 8 days), follow-up at one month (T2))
  • Participation (COPM, PEM-CY)(Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2))
  • GMFM-66 (Gross Motor Function Measure-66 Item Set)(Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2))
  • Pediatric Balance Scale (PBS)(Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2))
  • Trunk Control Measurement Scale (TCMS-S)(Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2))
  • Children's Hand-use Experience Questionnaire (CHEQ(Baseline (T0), immediately after intervention (T1, 8 days))

研究者

发起方
University of Castilla-La Mancha
申办方类型
Other
责任方
Sponsor

相似试验

Intensive Somatosensory Camp for Manual Function and... | 临床试验