Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy

Universidad San Jorge

Status: Completed

Conditions: Cerebral Palsy Infantile; Hemiplegia and Hemiparesis

Treatments: Device: Upper-limb splint; Device: Home-based protocol in specific tasks

Study type: Interventional

Funder types: Other

Identifiers

NCT03282422

FF_TE_01_Versión 3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of unilateral cerebral palsy (hemiplegia-hemiparesis).
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

1. Cognitive impairment identified by the school report.
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 ...).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups

Intervention group

Experimental group

Description:

Upper-limb splint and home-based protocol in specific tasks

Treatment:

Device: Upper-limb splint

Device: Home-based protocol in specific tasks

Control group

Active Comparator group

Description:

Home-based protocol in specific tasks

Treatment:

Device: Home-based protocol in specific tasks