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

Not Applicable

Completed

• Conditions: Unilateral Cerebral Palsy

• Registration Number: NCT04235088
• Lead Sponsor: Universidad San Jorge

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 4 procedures:

1. - Assessment pre-intervention

2. - Intervention: three weeks

3. - Assessment post-intervention

4. - Follow-up assessment (three months after intervention).

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-21
• Study Start: 2020-02-05
• Primary Completion: 2020-09-12
• Study Completion: 2021-03-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Canadian Occupational Performance Measure (COPM).	baseline, immediately after intervention and follow up (3 months after intervention).	Participation measure (family aims).
Change in Children´s hand-use Experience Questionnaire (CHEQ).	baseline, immediately after intervention and follow up (3 months after intervention).	Activity Measure (bimanual performance).

Secondary Outcome Measures

Name	Time	Method
Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT).	baseline, immediately after intervention and follow up (3 months after intervention).	Activity measure (daily activities, mobility, social/cognitive and responsibility).
Change in Box and Blocks Test.	baseline, immediately after intervention and follow up (3 months after intervention).	Activity measure (unilateral gross manual dexterity).
Change in Sensory Profile™ 2 family Questionnaire (Winnie Dunn)	baseline, immediately after intervention and follow up (3 months after intervention).	Evaluate a child's sensory processing patterns in the context of home, school, and community-based activities.
Change in Kidscreen Questionnaire.	baseline, immediately after intervention and follow up (3 months after intervention).	Participation measure (Quality of live).
Change in Dynamometer (grip strength)	baseline, immediately after intervention and follow up (3 months after intervention).	Body structures and functions measure (grip strength).
Change in Jebsen Taylor Hand Function Test.	baseline, immediately after intervention and follow up (3 months after intervention).	Activity Measure (unimanual capacity).
Change in Somatosensory Battery Assessment.	baseline, immediately after intervention and follow up (3 months after intervention).	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).
Change in Pinch Gauge (pinch strength).	baseline, immediately after intervention and follow up (3 months after intervention).	Body structures and functions measure (pinch strength).

Trial Locations

Locations (1)

Asociación para la Investigación en la Discapacidad Motriz (AIDIMO); 🇪🇸 Zaragoza, Spain