Intensive Somatosensory Camp for Manual Function and Participation in Children With Unilateral Cerebral Palsy

NCT07487857 | Not Yet Recruiting

• 1 other identifier: CAMPUSENS
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy

Keywords

unilateral cerebral palsy; hemiparesis; upper limb function; somatosensory training; intensive rehabilitation; bimanual performance; pediatric; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (9)

• 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)

Study Arms (2)

Experimental: Somatosensory-Motor Intensive Camp

EXPERIMENTAL

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.

Behavioral: Motor-Only Intensive Camp

Active Comparator: Motor Camp

ACTIVE COMPARATOR

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

Behavioral: Somatosensory-Motor Intensive Camp

Interventions

Somatosensory-Motor Intensive Camp BEHAVIORAL

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 daily activities.

Active Comparator: Motor Camp

Motor-Only Intensive Camp BEHAVIORAL

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.

Experimental: Somatosensory-Motor Intensive Camp

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

MeSH Terms

Conditions

Cerebral Palsy; Paresis

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rocío Palomo Carrión PhD

CONTACT

926051821; rocio.palomo@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share