Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment App… (NCT03282422) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy
Spain33 participantsStarted 2017-09-11
Plain-language 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.
Who can participate
Age range5 Years – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ...).
✕
What they're measuring
1
Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks
Timeframe: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
2
Primary Outcome_2. Change from baseline Children's Hand-use Experience Questionnaire measure. Measurement of bimanual performance in activities of daily living.
Timeframe: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).