Web-based Daily Care Training of Children With Cerebral Palsy

September 9, 2015 updated by: Zahra Nobakht, University of Social Welfare and Rehabilitation Science

Ethics Committee of the University of Social Welfare and Rehabilitation Science

Purpose:Effect of web-based daily care training on the quality of life of caregivers of children with cerebral palsy.

study design: Single-blind clinical trial. study population: Caregivers of children with cerebral palsy. Inclusion criteria: caregiver -Mother of a child with cerebral palsy who spent most time on child care- Children with cerebral palsy aged 4 to 12 years old living in Alborz province that clinical diagnosis of cerebral palsy registered in their clinical records. Moderate and severe cerebral palsy (gross motor function levels 3 to 5). caregiver have facilities and basic knowledge of using Internet (Declared access to the Internet at least one hour a week). exclusion criteria: taking care of two or more children with disability. participated in previous face to face training programs.

Sample size: 100. Intervention: Web-based daily care training. intervention time: 12-week. Outcome of the study: the quality of life of caregivers

Study Overview

Status

Unknown

Conditions

Detailed Description

step1: web development and design

  1. development of educational content (4 weeks)
  2. Create a paper version of the site (2 weeks)
  3. Create a web-based version of the site (4 weeks)
  4. pilot study (6 weeks) step 2: RCT (12 weeks)

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • caregiver_ Mother of a child with cerebral palsy who spent most time on child care Children with cerebral palsy aged 4 to 12 years old living in Alborz province that clinical diagnosis of cerebral palsy registered in their clinical records
  • Moderate and severe cerebral palsy (gross motor function levels 3 to 5)
  • caregiver have facilities and basic knowledge of using Internet (Declared access to the Internet at least one hour a week)

Exclusion Criteria:

  • taking care of two or more children with disability
  • participated in previous training programs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
web-based daily care training 12 week interactive web based caring training education
12 week interactive web based caring training education
No Intervention: control
Previous therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
quality of life of caregivers
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Zahra Nobakht, PhD student, Occupational therapy department, University of Social Welfare and Rehabilitation Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 7, 2015

First Submitted That Met QC Criteria

September 7, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Estimate)

September 10, 2015

Last Update Submitted That Met QC Criteria

September 9, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • IR.USWR.REC.1394.111

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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