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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-15
SponsorUniversity of Castilla-La Mancha

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: Experimental: Somatosensory-Motor Intensive CampExperimental treatment 1 intervention
Group B: Active Comparator: Motor CampActive comparator 1 intervention

Trial outcomes

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).

Time frame
Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)

Secondary outcomes

1

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.

Time frame
Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)
2

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).

Time frame
Baseline (T0), immediately after intervention (T1, 8 days), follow-up at one month (T2)
3

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.

Time frame
Baseline (T0), immediately after intervention (T1, 8 days), follow-up at one month (T2)
4

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.

Time frame
Baseline (T0), during daily life in camps days, immediately after intervention (T1, 8 days), follow-up at one month (T2)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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