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

Unilateral Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235088
• Other study ID #: UCP Somatosensory intervention
• Status: Completed
• Phase: N/A
• Start date: February 5, 2020
• Est. completion date: March 12, 2021

Study information

• Verified date: May 2021
• Source: Universidad San Jorge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 12, 2021
• Est. primary completion date: September 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Unilateral Cerebral Palsy

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.

Locations

Country	Name	City	State
Spain	Asociación para la Investigación en la Discapacidad Motriz (AIDIMO)	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad San Jorge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Canadian Occupational Performance Measure (COPM).	Participation measure (family aims).	baseline, immediately after intervention and follow up (3 months after intervention).
Primary	Change in Children´s hand-use Experience Questionnaire (CHEQ).	Activity Measure (bimanual performance).	baseline, immediately after intervention and follow up (3 months after intervention).
Secondary	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 and follow up (3 months after intervention).
Secondary	Change in Jebsen Taylor Hand Function Test.	Activity Measure (unimanual capacity).	baseline, immediately after intervention and follow up (3 months after intervention).
Secondary	Change in Box and Blocks Test.	Activity measure (unilateral gross manual dexterity).	baseline, immediately after intervention and follow up (3 months after intervention).
Secondary	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 and follow up (3 months after intervention).
Secondary	Change in Kidscreen Questionnaire.	Participation measure (Quality of live).	baseline, immediately after intervention and follow up (3 months after intervention).
Secondary	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 and follow up (3 months after intervention).
Secondary	Change in Dynamometer (grip strength)	Body structures and functions measure (grip strength).	baseline, immediately after intervention and follow up (3 months after intervention).
Secondary	Change in Pinch Gauge (pinch strength).	Body structures and functions measure (pinch strength).	baseline, immediately after intervention and follow up (3 months after intervention).