Back to resultsImpact of Somatosensory Intensive Intervention on Motor Performance in Children With Unilateral Cerebral Palsy
Primary Purpose
Unilateral Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Somatosensory intensive intervention
Sponsored by
About this trial
This is an interventional treatment trial for Unilateral Cerebral Palsy focused on measuring somatosensory intensive intervention, somatosensory processing, motor performance, participation, quality of live, occupational performance
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
Sites / Locations
- Asociación para la Investigación en la Discapacidad Motriz (AIDIMO)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Somatosensory intensive intervention
Arm Description
Outcomes
Primary Outcome Measures
Change in Canadian Occupational Performance Measure (COPM).
Participation measure (family aims).
Change in Children´s hand-use Experience Questionnaire (CHEQ).
Activity Measure (bimanual performance).
Secondary Outcome Measures
Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT).
Activity measure (daily activities, mobility, social/cognitive and responsibility).
Change in Jebsen Taylor Hand Function Test.
Activity Measure (unimanual capacity).
Change in Box and Blocks Test.
Activity measure (unilateral gross manual dexterity).
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.
Change in Kidscreen Questionnaire.
Participation measure (Quality of live).
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).
Change in Dynamometer (grip strength)
Body structures and functions measure (grip strength).
Change in Pinch Gauge (pinch strength).
Body structures and functions measure (pinch strength).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04235088
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
September 12, 2020 (Actual)
Study Completion Date
March 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad San Jorge
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
- Assessment pre-intervention
- Intervention: three weeks
- Assessment post-intervention
- Follow-up assessment (three months after intervention).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Cerebral Palsy
Keywords
somatosensory intensive intervention, somatosensory processing, motor performance, participation, quality of live, occupational performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Somatosensory intensive intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Somatosensory intensive intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Canadian Occupational Performance Measure (COPM).
Description
Participation measure (family aims).
Time Frame
baseline, immediately after intervention and follow up (3 months after intervention).
Title
Change in Children´s hand-use Experience Questionnaire (CHEQ).
Description
Activity Measure (bimanual performance).
Time Frame
baseline, immediately after intervention and follow up (3 months after intervention).
Secondary Outcome Measure Information:
Title
Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT).
Description
Activity measure (daily activities, mobility, social/cognitive and responsibility).
Time Frame
baseline, immediately after intervention and follow up (3 months after intervention).
Title
Change in Jebsen Taylor Hand Function Test.
Description
Activity Measure (unimanual capacity).
Time Frame
baseline, immediately after intervention and follow up (3 months after intervention).
Title
Change in Box and Blocks Test.
Description
Activity measure (unilateral gross manual dexterity).
Time Frame
baseline, immediately after intervention and follow up (3 months after intervention).
Title
Change in Sensory Profile™ 2 family Questionnaire (Winnie Dunn)
Description
Evaluate a child's sensory processing patterns in the context of home, school, and community-based activities.
Time Frame
baseline, immediately after intervention and follow up (3 months after intervention).
Title
Change in Kidscreen Questionnaire.
Description
Participation measure (Quality of live).
Time Frame
baseline, immediately after intervention and follow up (3 months after intervention).
Title
Change in Somatosensory Battery Assessment.
Description
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).
Time Frame
baseline, immediately after intervention and follow up (3 months after intervention).
Title
Change in Dynamometer (grip strength)
Description
Body structures and functions measure (grip strength).
Time Frame
baseline, immediately after intervention and follow up (3 months after intervention).
Title
Change in Pinch Gauge (pinch strength).
Description
Body structures and functions measure (pinch strength).
Time Frame
baseline, immediately after intervention and follow up (3 months after intervention).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
César Cuesta García
Organizational Affiliation
Occupational Thinks Research Group, Autónoma University (Madrid)
Official's Role
Study Director
Facility Information:
Facility Name
Asociación para la Investigación en la Discapacidad Motriz (AIDIMO)
City
Zaragoza
ZIP/Postal Code
50011
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Somatosensory Intensive Intervention on Motor Performance in Children With Unilateral Cerebral Palsy
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