Clinical trial NCT04235088: Impact of Somatosensory Intensive Intervention on Motor Performance in Children With Unilateral Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Cerebral Palsy
Keywords: somatosensory intensive intervention
somatosensory processing
motor performance
participation
quality of live
occupational performance
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Canadian Occupational Performance Measure (COPM).
timeFrame: baseline, immediately after intervention and follow up (3 months after intervention).
measure: Change in Children´s hand-use Experience Questionnaire (CHEQ).
timeFrame: baseline, immediately after intervention and follow up (3 months after intervention).
Secondary outcomes:
measure: Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT).
timeFrame: baseline, immediately after intervention and follow up (3 months after intervention).
measure: Change in Jebsen Taylor Hand Function Test.
timeFrame: baseline, immediately after intervention and follow up (3 months after intervention).
measure: Change in Box and Blocks Test.
timeFrame: baseline, immediately after intervention and follow up (3 months after intervention).
measure: Change in Sensory Profile™ 2 family Questionnaire (Winnie Dunn)
timeFrame: baseline, immediately after intervention and follow up (3 months after intervention).
measure: Change in Kidscreen Questionnaire.
timeFrame: baseline, immediately after intervention and follow up (3 months after intervention).
measure: Change in Somatosensory Battery Assessment.
timeFrame: baseline, immediately after intervention and follow up (3 months after intervention).
measure: Change in Dynamometer (grip strength)
timeFrame: baseline, immediately after intervention and follow up (3 months after intervention).
measure: Change in Pinch Gauge (pinch strength).
timeFrame: baseline, immediately after intervention and follow up (3 months after intervention).
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Asociación para la Investigación en la Discapacidad Motriz (AIDIMO)
Study officials:
affiliation: Occupational Thinks Research Group, Autónoma University (Madrid)
name: César Cuesta García
role: STUDY_DIRECTOR
References: