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CompletedNCT04235088Updated Apr 16, 2026

Impact of Somatosensory Intensive Intervention on Motor Performance in Children With Unilateral Cerebral Palsy

An interventional study of Somatosensory intensive intervention in Unilateral Cerebral Palsy, sponsored by Universidad San Jorge. Completed at 1 site in Spain. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Universidad San Jorge · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
6 Years to 15 Years
Sex
All
01

Study summary

This study aims to investigate the effectiveness of an intensive somatosensory intervention in the upper limb of children with hemiparesis regarding structure, function, activity and participation

Hypothesis:

Intensive somatosensory activity based intervention is effective in upper limb and hand ability in children with hemiparesis, specially regarding activity and participation

Read the detailed description

Feasibility and longitudinal study with blinding of the evaluator and the person analyzing the data. The study have 3 procedures:

  1. - Assessment pre-intervention
  2. - Intervention: three weeks
  3. - Assessment post-intervention
02

Conditions studied

  • Unilateral Cerebral Palsy

Keywords

  • somatosensory intensive intervention
  • somatosensory processing
  • motor performance
  • participation
  • quality of live
  • occupational performance
03

Who can participate

Ages eligible
6 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of unilateral cerebral palsy
  • Manual Ability Classification System (MACS): levels I, II y III.
  • Gender: male and female
  • Age: 6 to 15 years old

Exclusion criteria

Exclusion Criteria:

  • Existence of a moderate or severe cognitive impairment, which could interfere with the comprehension of the tester cues
  • Botulinum toxic infiltration 4 months before the date of the pre-intervention assessment or during intervention or during the 3 months after the final intervention
  • To have suffered any injury such as fractures and/or contusions in the upper limb in the last 12 months
  • Orthopedic intervention in the 6 months preceding the study or during the study
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Somatosensory intensive intervention

    Other: Somatosensory intensive intervention

Interventions

  • OtherSomatosensory intensive intervention

    The intensive somato-sensory intervention will take place during 3 weeks, 5 days per week, for 2 hours per day (30 hours of practice). During the week-ends, some somato-sensory written activities will be explained and handed to each family (6 hours of practice) Therapy sessions will be carried out in groups and each child will have his or her own therapist in charge of his or her treatment along the whole intervention. A daily check-list, design for that purpose, will be used by the therapist in order to register the gradually increased complexity of the activities and individual progression. The principal investigator will supervise all the interventions in order to assure their uniformity, adjusting the somato-sensory training protocol to the individual needs of each subject.

05

What researchers measure

Primary outcomes

  1. Change in Canadian Occupational Performance Measure (COPM).

    Participation measure (family aims). Primary outcomes will be reported in separate manuscripts due to scope/space considerations.

    Time frame: baseline, immediately after intervention

  2. Change in Children´s hand-use Experience Questionnaire (CHEQ).

    Activity Measure (bimanual performance). Primary outcomes will be reported in separate manuscripts due to scope/space considerations.

    Time frame: baseline, immediately after intervention

Secondary outcomes

  1. Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT).

    Activity measure (daily activities, mobility, social/cognitive and responsibility).

    Time frame: baseline, immediately after intervention

  2. Change in Jebsen Taylor Hand Function Test.

    Activity Measure (unimanual capacity).

    Time frame: baseline, immediately after intervention

  3. Change in Box and Blocks Test.

    Activity measure (unilateral gross manual dexterity).

    Time frame: baseline, immediately after intervention

  4. Change in Sensory Profile™ 2 family Questionnaire (Winnie Dunn)

    Evaluate a child's sensory processing patterns in the context of home, school, and community-based activities.

    Time frame: baseline, immediately after intervention

  5. Change in Kidscreen Questionnaire.

    Participation measure (Quality of live).

    Time frame: baseline, immediately after intervention

  6. Change in Somatosensory Battery Assessment.

    Body structures and functions measure. Includes: registration (Semmes Weinstein monofilaments); Two points discrimination (Aesthesiometer); Single Point Location; double simultaneous, forms stereognosis (Manual Form Perception Test\_ SIPT), stereognosis of familiar objects, graphesthesia (SIPT), clinical observation of texture perception, clinical observation of proprioception, pain (algometer) and functional sensitivity (Box and Blocks without vision).

    Time frame: baseline, immediately after intervention

  7. Change in Dynamometer (grip strength)

    Body structures and functions measure (grip strength).

    Time frame: baseline, immediately after intervention

  8. Change in Pinch Gauge (pinch strength).

    Body structures and functions measure (pinch strength).

    Time frame: baseline, immediately after intervention

06

Study locations

1 site
  • Asociación para la Investigación en la Discapacidad Motriz (AIDIMO)
    Zaragoza, Zaragoza 50011, Spain
07

References and documents

Publications

  • Jovellar-Isiegas P, Roche-Seruendo LE, Jaen-Carrillo D, Gomez-Barrera M, Cuesta-Garcia C. An exploratory pre-post study of an intensive somatosensory activity-based intervention on participation-related goals, motor performance and somatosensory function in children with unilateral cerebral palsy. Front Pediatr. 2026 Jun 25;14:1862592. doi: 10.3389/fped.2026.1862592. eCollection 2026. PubMed 42427947 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04235088
Lead sponsor
Universidad San Jorge
Responsible party
Sponsor
First posted
Jan 21, 2020
Start date
Sep 5, 2020
Primary completion
Mar 12, 2021
Completion
Mar 12, 2021
Last update
Apr 16, 2026

Study contacts

César Cuesta García
study director · Occupational Thinks Research Group, Autónoma University (Madrid)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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