Cerebral PalsyNCT02545179
Web-based Daily Care Training of Children With Cerebral Palsy
A study testing web-based daily care training in people with Cerebral Palsy, run by University of Social Welfare and Rehabilitation Science.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- web-based daily care training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- taking care of two or more children with disability
- participated in previous training programs
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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)
- Conditions
- Cerebral Palsy
- Being tested
- web-based daily care training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based daily care trainingOther
12 week interactive web based caring training education
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | web-based daily care training 12 week interactive web based caring training education Receives: Other: web-based daily care training |
| control | No intervention | Previous therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life of caregivers
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Social Welfare and Rehabilitation Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Nobakht, University of Social Welfare and Rehabilitation Science
- Investigators
- Zahra Nobakht, PhD student, Principal investigator, Occupational therapy department, University of Social Welfare and Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545179
- Sponsor's protocol ID
- IR.USWR.REC.1394.111
- Status last verified
- Sep 2015
- First submitted
- 7 Sep 2015
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethics Committee of the University of Social Welfare and Rehabilitation Science
- ClinicalTrials.gov ID
- NCT02545179
- Acronym / sponsor ID
- IR.USWR.REC.1394.111
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Social Welfare and Rehabilitation ScienceUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: web-based daily care trainingweb-based daily care training 12 week interactive web based caring training education |
| control | No intervention | –Previous therapy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- taking care of two or more children with disability
- participated in previous training programs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web-based daily care training12 week interactive web based caring training education | Other | intervention |
Primary outcome
quality of life of caregivers
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahra Nobakht, PhD student principal investigator
Occupational therapy department, University of Social Welfare and Rehabilitation Sciences
Questions about this trial
What is this clinical trial studying?
A study testing web-based daily care training in people with Cerebral Palsy, run by University of Social Welfare and Rehabilitation Science.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zahra Nobakht, PhD student (00982122180037, nobakht.zahra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life of caregivers (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2015.