- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02545179
Web-based Daily Care Training of Children With Cerebral Palsy
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
Conditions
Intervention / Treatment
Detailed Description
step1: web development and design
- development of educational content (4 weeks)
- Create a paper version of the site (2 weeks)
- Create a web-based version of the site (4 weeks)
- pilot study (6 weeks) step 2: RCT (12 weeks)
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: Zahra Nobakht, PhD student, Occupational therapy department, University of Social Welfare and Rehabilitation Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IR.USWR.REC.1394.111
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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