Impact of an Education Program for Parents of Children With Cerebral Palsy

NCT02490462 | Unknown

• 1 other identifier: FUBahia060278
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The Physical Therapy for children with Cerebral Palsy is of great complexity, in addition to improving the neuromotor components at the level of structure and body function, must empower them to carry out their activities and daily tasks and enable their social participation. In this way, the goals of Physical Therapy are related to promote the independence and functionality of the individual in situations of daily life. The participation of caregivers in the rehabilitation process can contribute to potentiate the gains obtained by physical therapy as well as to which they are incorporated into the day to day management of children with cerebral palsy. Objective: To assess whether Physical Therapy associated with the education of caregivers is effective in improving the functioning and quality of life of children with cerebral palsy. Hypothesis: The combination of Physical therapy with the education of caregivers improves in 15% the parameters analyzed against only 10% in those who are only Physical Therapy. Methods: 60 children with cerebral palsy after acceptance and signature in the term of informed consent will be randomly divided into 2 groups (G1: Physiotherapy and education of caregivers and G2: only Physical Therapy) to do 3 sessions of Physical Therapy and 1 weekly session of group education with duration of 45 min during 12 consecutive weeks. The evaluation will be carried out by means of the System of Classification of Motor Function Gross (GMFCS), the evaluation of Motor Function through the scale GMFM-88 (Gross Motor Function Measure - 88 ) and the Activity and Participation will be evaluated by the Inventory of Evaluation of Pediatric Disability (PEDI). The analysis of the results will be carried out using the Statistical Package for the Social Sciences (SPSS) using descriptive statistics for social and demographic characteristics and inferential for normality of data (test Kolmogorov-Smirnov ), mean comparison test to check for differences between the groups and measures of association through the coefficient of correlation. The level of significance of 5% will be established

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Physical Therapy; Family-centered Care

Outcome Measures

Primary Outcomes (1)

• Improvement in Functionality

  Assess whether the associated physical therapy education of caregivers is effective in improving the functionality of children with cerebral palsy after a 12-week period.

  12 weeks

Secondary Outcomes (4)

• Gross Motor Function

  12 weeks

• Improvement in Functionality

  12 weeks

• Motor performance and functional

  12 weeks

• Frequency of exercises

  12 weeks

Study Arms (2)

Education + Conventional PhysicalTherapy

EXPERIMENTAL

Parents of children with cerebral palsy receive instructions for active inclusion of children in everyday activities. The education program for parents will take place once a week for twelve weeks. Children with Cerebral Palsy make conventional physical therapy twice a week for a period of twelve weeks.

Other: Education + Conventional PhysicalTherapy

Conventional Physical Therapy

ACTIVE COMPARATOR

Children with Cerebral Palsy make conventional physical therapy twice a week for a period of twelve weeks.

Other: Conventional Physical Therapy

Interventions

Education + Conventional PhysicalTherapy OTHER

The education program for parents will be held one day a week for 1 hour, with total duration of 12 weeks. During the parents or legal guardian meetings will be oriented to stimulate the drive to your child or ward during everyday activities such as bathing, dressing, eating, transferring, going to the bathroom. Parents will receive a diary to record the activities in the home environment. The orientation day for parents will take place in different days of the day the child will receive physical therapy, so that the physiotherapist responsible for the training of parents is shrouded in relation to the randomization of the subjects. This program will be associated with conventional physical therapy program that provides for movements based on neurodevelopmental concept.

Education + Conventional PhysicalTherapy

Conventional Physical Therapy OTHER

The full program will be for 24 weeks, the first step will consist of 12 weeks of training with a frequency of twice a week should total at least 18 Conventional physical therapy interventions and 09 meetings of guidelines for parents. After this step be performed to start new reviews second step further 12 weeks with the same characteristics as the first 12 weeks. The conventional physiotherapy program will consist of functional muscle training focused on the task. Tasks will be individualized based on the results of the evaluations of Gross Motor Function and Inventory Pediatric Evaluation of Disability. The sessions will last 45 minutes carried out 2 times a week, training will have a total duration of 12 weeks.

Conventional Physical Therapy

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Cerebral Palsy diagnosis for children,
• Children will be included presenting grade II, III on Classification System of Gross Motor Function (GMFCS) aged 6 months to 12 years old.
• Parent or caregiver who devote yourself full-time to the child,
• Acceptance of parents for children to participate in the protocol by signing the free and informed consent form.

You may not qualify if:

• Peripheral nervous system disease or brain stem
• Children with other chronic diseases receiving palliative care,
• Children who present bone deformity and scoliosis structured Cobb \> 30 and lower limb deformity.

Sponsors & Collaborators

• Federal University of Bahia: lead

Study Sites (1)

Mansueto Gomes Neto

Salvador, Estado de Bahia, 41950350, Brazil

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Manseuto Gomes Neto

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mansueto Gomes Neto

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: July 3, 2015
• Study Start: May 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

BR (1)