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

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

Study Overview

• Status: Completed
• Conditions: Unilateral Cerebral Palsy
• Intervention / Treatment: Other: Somatosensory intensive intervention

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

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Somatosensory intensive intervention

Other: Somatosensory 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT).	Activity measure (daily activities, mobility, social/cognitive and responsibility).	baseline, immediately after intervention
Change in Jebsen Taylor Hand Function Test.	Activity Measure (unimanual capacity).	baseline, immediately after intervention
Change in Box and Blocks Test.	Activity measure (unilateral gross manual dexterity).	baseline, immediately after intervention
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.	baseline, immediately after intervention
Change in Kidscreen Questionnaire.	Participation measure (Quality of live).	baseline, immediately after intervention
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).	baseline, immediately after intervention
Change in Dynamometer (grip strength)	Body structures and functions measure (grip strength).	baseline, immediately after intervention
Change in Pinch Gauge (pinch strength).	Body structures and functions measure (pinch strength).	baseline, immediately after intervention

Collaborators and Investigators

• Sponsor: Universidad San Jorge
• Investigators: Study Director: César Cuesta García, Occupational Thinks Research Group, Autónoma University (Madrid)

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2020
• Primary Completion (Actual): March 12, 2021
• Study Completion (Actual): March 12, 2021

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: quality of live; participation; somatosensory intensive intervention; somatosensory processing; motor performance; occupational performance
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: UCP Somatosensory intervention

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No