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

NCT03282422 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-07-17

No results posted yet for this study

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.

Conditions

  • Hemiplegia and Hemiparesis
  • Cerebral Palsy Infantile

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • AIDIMO Asociación para la investigación en la discapacidad motriz

    collaborator UNKNOWN

  • Universidad San Jorge

    lead OTHER

Principal Investigators

  • María Ortiz Lucas, PhD · Universidad San Jorge

  • Vanesa Abuín Porras, PhD · Universidad Europea de Madrid

  • Patricia Roldán Pérez, MSc · Universidad San Jorge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-11
Primary Completion
2019-02-28
Completion
2019-03-19

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03282422 on ClinicalTrials.gov