Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy
NCT ID: NCT03282422
Last Updated: 2019-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2017-09-11
2019-03-19
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention group
Upper-limb splint and home-based protocol in specific tasks
Home-based protocol in specific tasks
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.
Upper-limb splint
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.
Control group
Home-based protocol in specific tasks
Home-based protocol in specific tasks
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.
Interventions
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Home-based protocol in specific tasks
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.
Upper-limb splint
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.
Eligibility Criteria
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Inclusion Criteria
2. Ages between 5 and 12 years.
3. Levels I-III of the Manual Ability Classification System (MACS)
4. Levels I-III of the Gross Motor Function Classification System (GMFCS)
5. Able to understand and respond to verbal instructions.
Exclusion Criteria
2. Hand orthopedic surgery in the last 6 months.
3. Neuropharmacological intervention in the last 6 months.
4. Allergy to upper limb orthosis material.
5. Affectation of the manual function not due to the neurological condition (trauma, burn ...).
6. Current treatments not compatible with the study.
7. Other significant neurological affections (crisis, severe visual impairment ...).
5 Years
12 Years
ALL
No
Sponsors
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AIDIMO Asociación para la investigación en la discapacidad motriz
UNKNOWN
Universidad San Jorge
OTHER
Responsible Party
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Principal Investigators
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María Ortiz Lucas, PhD
Role: STUDY_DIRECTOR
Universidad San Jorge
Vanesa Abuín Porras, PhD
Role: STUDY_DIRECTOR
Universidad Europea de Madrid
Patricia Roldán Pérez, MSc
Role: PRINCIPAL_INVESTIGATOR
Universidad San Jorge
Locations
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AIDIMO Asociación para la investigación en la discapacidad motriz
Zaragoza, , Spain
Universidad San Jorge
Zaragoza, , Spain
Countries
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References
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Other Identifiers
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FF_TE_01_Versión 3
Identifier Type: -
Identifier Source: org_study_id
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