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

Impact of Somatosensory Intensive Intervention on Motor Performance of the Upper Limb and Participation in Children With Unilateral Cerebral Palsy: a Feasibility Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04235088
Enrollment
16
Registered
2020-01-21
Start date
2020-09-05
Completion date
2021-03-12
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Cerebral Palsy

Keywords

somatosensory intensive intervention, somatosensory processing, motor performance, participation, quality of live, occupational performance

Brief 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

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

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.

Sponsors

Universidad San Jorge
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 15 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Canadian Occupational Performance Measure (COPM).baseline, immediately after interventionParticipation measure (family aims). Primary outcomes will be reported in separate manuscripts due to scope/space considerations.
Change in Children´s hand-use Experience Questionnaire (CHEQ).baseline, immediately after interventionActivity Measure (bimanual performance). Primary outcomes will be reported in separate manuscripts due to scope/space considerations.

Secondary

MeasureTime frameDescription
Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT).baseline, immediately after interventionActivity measure (daily activities, mobility, social/cognitive and responsibility).
Change in Jebsen Taylor Hand Function Test.baseline, immediately after interventionActivity Measure (unimanual capacity).
Change in Box and Blocks Test.baseline, immediately after interventionActivity measure (unilateral gross manual dexterity).
Change in Sensory Profile™ 2 family Questionnaire (Winnie Dunn)baseline, immediately after interventionEvaluate a child's sensory processing patterns in the context of home, school, and community-based activities.
Change in Kidscreen Questionnaire.baseline, immediately after interventionParticipation measure (Quality of live).
Change in Somatosensory Battery Assessment.baseline, immediately after interventionBody 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).
Change in Dynamometer (grip strength)baseline, immediately after interventionBody structures and functions measure (grip strength).
Change in Pinch Gauge (pinch strength).baseline, immediately after interventionBody structures and functions measure (pinch strength).

Countries

Spain

Contacts

STUDY_DIRECTORCésar Cuesta García

Occupational Thinks Research Group, Autónoma University (Madrid)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026