Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07487857
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT07487857
Study Brief:
Protocol Section:
NCT07487857