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

NCT04235088 | Completed

• 1 other identifier: UCP Somatosensory intervention
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Unilateral Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Canadian Occupational Performance Measure (COPM).

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

  baseline, immediately after intervention

• 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.

  baseline, immediately after intervention

Secondary Outcomes (8)

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

  baseline, immediately after intervention

• Change in Jebsen Taylor Hand Function Test.

  baseline, immediately after intervention

• Change in Box and Blocks Test.

  baseline, immediately after intervention

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

  baseline, immediately after intervention

• Change in Kidscreen Questionnaire.

  baseline, immediately after intervention

Study Arms (1)

Somatosensory intensive intervention

EXPERIMENTAL

Other: Somatosensory intensive intervention

Interventions

Somatosensory intensive intervention OTHER

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.

Somatosensory intensive intervention

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad San Jorge: lead

Study Sites (1)

Asociación para la Investigación en la Discapacidad Motriz (AIDIMO)

Zaragoza, Zaragoza, 50011, Spain

Location

Study Officials

• César Cuesta García

  Occupational Thinks Research Group, Autónoma University (Madrid)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 21, 2020
• Study Start: September 5, 2020
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)