Back to resultsEffectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy
Primary Purpose
Hemiplegia and Hemiparesis, Cerebral Palsy Infantile
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Home-based protocol in specific tasks
Upper-limb splint
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegia and Hemiparesis focused on measuring Cerebral palsy, Hemiplegia, Upper-limb splint, Home-based, Social Participation
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of unilateral cerebral palsy (hemiplegia-hemiparesis).
- Ages between 5 and 12 years.
- Levels I-III of the Manual Ability Classification System (MACS)
- Levels I-III of the Gross Motor Function Classification System (GMFCS)
- Able to understand and respond to verbal instructions.
Exclusion Criteria:
- Cognitive impairment identified by the school report.
- Hand orthopedic surgery in the last 6 months.
- Neuropharmacological intervention in the last 6 months.
- Allergy to upper limb orthosis material.
- Affectation of the manual function not due to the neurological condition (trauma, burn ...).
- Current treatments not compatible with the study.
- Other significant neurological affections (crisis, severe visual impairment ...).
Sites / Locations
- AIDIMO Asociación para la investigación en la discapacidad motriz
- Universidad San Jorge
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Upper-limb splint and home-based protocol in specific tasks
Home-based protocol in specific tasks
Outcomes
Primary Outcome Measures
Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks
Activity measurement: Assisting Hand Assessment. Measurement of bimanual performance in pre-established tasks. It quantifies the effectiveness with which the child uses his affected hand in bimanual activities.
Primary Outcome_2. Change from baseline Children's Hand-use Experience Questionnaire measure. Measurement of bimanual performance in activities of daily living.
Participation and activity measurement: Children's Hand-use Experience Questionnaire. The objective of the questionnaire is to measure bimanual performance in activities of daily living.
Secondary Outcome Measures
Secondary Outcome_Change from baseline Box and Blocks Test measure. Measurement of unilateral gross manual dexterity.
Activity measurement: Box and Blocks Test assesses unilateral gross manual dexterity.
Secondary Outcome_2. Change from baseline Jebsen Hand Function Test measure. Measurement of a broad range of uni-manual hand functions required for activities of daily living.
Participation measurement: Jebsen Hand Function Test. The objective of this test is to assess a broad range of uni-manual hand functions required for activities of daily living.7 activities performed with the affected hand and healthy hand separately.
Secondary Outcome_3. Change from baseline House Thumb in Palm Deformity Classification. Classify the deformity level of thumb.
Structure and function measurement: House Thumb in Palm Deformity Classification. This tool classify the deformity levels taking into account the structure of the thumb.
Secondary Outcome_4. Change from baseline Neurological Hand Deformity Classification. This tool classify the deformity levels of wrist and fingers.
Structure and function measurement: Neurological Hand Deformity Classification. This tools classify the deformity levels taking into account the wrist, fingers.
Secondary Outcome_5. Change from baseline Grip and Pinch Strength measure. Measurement of pinch, wrist and foream strength.
Structure and function measurement: Grip and Pinch Strength. One will be used to Assess the grip of the thumb (Pinch Gauge Dynamometer) and another to assess the strength of the wrist and forearm (Hand and Wrist Dynamometer).
Full Information
NCT ID
NCT03282422
First Posted
September 6, 2017
Last Updated
July 16, 2019
Sponsor
Universidad San Jorge
Collaborators
AIDIMO Asociación para la investigación en la discapacidad motriz
1. Study Identification
Unique Protocol Identification Number
NCT03282422
Brief Title
Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy
Official Title
Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy. Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
March 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad San Jorge
Collaborators
AIDIMO Asociación para la investigación en la discapacidad motriz
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
The main objective:
To determine the effectiveness of a treatment that combines the application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy versus a home-based program of specific tasks in improving structure and function, activity and participation.
Hypothesis:
The application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy results in a greater improvement in structure and function, activity and participation compared to the implementation of a home-based specific task program.
Detailed Description
Randomized clinical trial with blinding of the evaluator and the person analyzing the data.
A home-based protocol of specific tasks will be performed in both groups and one of the groups will also receive a treatment with upper limb splinting. The assessment will be made by a single evaluator with 10 years of experience in the treatment of children with motor disabilities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia and Hemiparesis, Cerebral Palsy Infantile
Keywords
Cerebral palsy, Hemiplegia, Upper-limb splint, Home-based, Social Participation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Upper-limb splint and home-based protocol in specific tasks
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Home-based protocol in specific tasks
Intervention Type
Device
Intervention Name(s)
Home-based protocol in specific tasks
Intervention Description
The home-based protocol in specific tasks will be an individualized protocol designed for the child according to the results of the baseline assessment and will require active participation. It is a program that is integrated into the daily routines of the child. A study investigator will tell the family the procedure to follow.
Intervention Type
Device
Intervention Name(s)
Upper-limb splint
Intervention Description
In the case that treatment with splint is also received, a researcher of this study will take measurements of the hand and will provide the appropriate splint. The intensity of the application will be 5 days a week from monday to friday, for 6 hours a day, for a period of 6 weeks.
Primary Outcome Measure Information:
Title
Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks
Description
Activity measurement: Assisting Hand Assessment. Measurement of bimanual performance in pre-established tasks. It quantifies the effectiveness with which the child uses his affected hand in bimanual activities.
Time Frame
Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Title
Primary Outcome_2. Change from baseline Children's Hand-use Experience Questionnaire measure. Measurement of bimanual performance in activities of daily living.
Description
Participation and activity measurement: Children's Hand-use Experience Questionnaire. The objective of the questionnaire is to measure bimanual performance in activities of daily living.
Time Frame
Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome Measure Information:
Title
Secondary Outcome_Change from baseline Box and Blocks Test measure. Measurement of unilateral gross manual dexterity.
Description
Activity measurement: Box and Blocks Test assesses unilateral gross manual dexterity.
Time Frame
Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Title
Secondary Outcome_2. Change from baseline Jebsen Hand Function Test measure. Measurement of a broad range of uni-manual hand functions required for activities of daily living.
Description
Participation measurement: Jebsen Hand Function Test. The objective of this test is to assess a broad range of uni-manual hand functions required for activities of daily living.7 activities performed with the affected hand and healthy hand separately.
Time Frame
Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Title
Secondary Outcome_3. Change from baseline House Thumb in Palm Deformity Classification. Classify the deformity level of thumb.
Description
Structure and function measurement: House Thumb in Palm Deformity Classification. This tool classify the deformity levels taking into account the structure of the thumb.
Time Frame
Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Title
Secondary Outcome_4. Change from baseline Neurological Hand Deformity Classification. This tool classify the deformity levels of wrist and fingers.
Description
Structure and function measurement: Neurological Hand Deformity Classification. This tools classify the deformity levels taking into account the wrist, fingers.
Time Frame
Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Title
Secondary Outcome_5. Change from baseline Grip and Pinch Strength measure. Measurement of pinch, wrist and foream strength.
Description
Structure and function measurement: Grip and Pinch Strength. One will be used to Assess the grip of the thumb (Pinch Gauge Dynamometer) and another to assess the strength of the wrist and forearm (Hand and Wrist Dynamometer).
Time Frame
Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of unilateral cerebral palsy (hemiplegia-hemiparesis).
Ages between 5 and 12 years.
Levels I-III of the Manual Ability Classification System (MACS)
Levels I-III of the Gross Motor Function Classification System (GMFCS)
Able to understand and respond to verbal instructions.
Exclusion Criteria:
Cognitive impairment identified by the school report.
Hand orthopedic surgery in the last 6 months.
Neuropharmacological intervention in the last 6 months.
Allergy to upper limb orthosis material.
Affectation of the manual function not due to the neurological condition (trauma, burn ...).
Current treatments not compatible with the study.
Other significant neurological affections (crisis, severe visual impairment ...).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María Ortiz Lucas, PhD
Organizational Affiliation
Universidad San Jorge
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vanesa Abuín Porras, PhD
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Patricia Roldán Pérez, MSc
Organizational Affiliation
Universidad San Jorge
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIDIMO Asociación para la investigación en la discapacidad motriz
City
Zaragoza
ZIP/Postal Code
50011
Country
Spain
Facility Name
Universidad San Jorge
City
Zaragoza
ZIP/Postal Code
50830
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy
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