Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy. Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hemiplegia and Hemiparesis
- Sponsor
- Universidad San Jorge
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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 ...).
Outcomes
Primary Outcomes
Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks
Time Frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
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.
Time Frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
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 Outcomes
- Secondary Outcome_4. Change from baseline Neurological Hand Deformity Classification. This tool classify the deformity levels of wrist and fingers.(Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).)
- Secondary Outcome_5. Change from baseline Grip and Pinch Strength measure. Measurement of pinch, wrist and foream strength.(Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).)
- Secondary Outcome_Change from baseline Box and Blocks Test measure. Measurement of unilateral gross manual dexterity.(Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).)
- 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.(Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).)
- Secondary Outcome_3. Change from baseline House Thumb in Palm Deformity Classification. Classify the deformity level of thumb.(Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).)