ClinicalTrials.gg
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

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 54 studies in Cerebral Palsy with a site in Spain — 15 open to participants now, 18 under way, 1 of them phase 3. Cerebral Palsy · Spain.

Enrollment
34th of 44
16 · median 32
Started
2020
with 4 others
No phase
37 of 54
12 open now
Registered
15th of 54
by date
Lead sponsor
2 of 54
Universidad San Jorge

Among the 54 studies in Cerebral Palsy with a site in Spain, this one is the 34th largest by enrollment of the 44 interventional ones that give a count, is one of 5 that started in 2020, is one of 37 with no phase, and was the 15th registered.

Cerebral Palsy

1,937 studies on the registry are indexed under Cerebral Palsy; 457 are open to participants now.

Browse Cerebral Palsy studies →

Open to participants now

15 of the 54 studies in Cerebral Palsy with a site in Spain are open now. Recruiting first, the newest first:

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All 15 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 269 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 234 (87%) stop at 75 or younger; 254 take children under 18; 51 take healthy volunteers.

This study: 6 Years to 15 Years · all sexes · no healthy volunteers.

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02

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
03

Conditions studied

  • Unilateral Cerebral Palsy

Browse trials for

Keywords

  • somatosensory intensive intervention
  • somatosensory processing
  • motor performance
  • participation
  • quality of live
  • occupational performance
04

Who can participate

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

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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
05

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.

06

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

07

Study locations

1 site
  • Asociación para la Investigación en la Discapacidad Motriz (AIDIMO)
    Zaragoza, Zaragoza 50011, Spain
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2020 to primary completion in Mar 2021, 6 months.

Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 6 months is below that.

Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2020
First posted
Jan 21, 2020
StartActual
Sep 5, 2020
Primary completionActual
Mar 12, 2021
CompletionActual
Mar 12, 2021
Last update
Apr 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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