Cerebral PalsyNCT02915926
Occupational Performance Coaching in Mothers of Children With Cerebral Palsy
A study testing occupational performance coaching and standard OT in people with Cerebral Palsy, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
Trial summary
A single-blind Randomized Controlled Trial will be used to test the efficacy of the OPC on self-efficacy and occupational performance with mothers of children with cerebral palsy. Canadian Occupational Performance Measurement and Sherer general self-efficacy scale will be employed to data collection. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- occupational performance coaching and standard OT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 26 Jul 2016to 19 Jan 2017
- 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- mothers: being literate 25 to 25 caring nobody disabled other than her child children: 5 to 12 cerebral palsy
Who cannot join
- children: others problems that affect on communication
Trial locations and contacts
1 site in 1 country.
About this study
A single-blind Randomized Controlled Trial will be used to test the efficacy of the OPC on self-efficacy and occupational performance with mothers of children with cerebral palsy. Canadian Occupational Performance Measurement and Sherer general self-efficacy scale will be employed to data collection. The sample size was determined for each group of 15 people. The participants conveniently and according to inclusion and exclusion criteria will be randomized into the groups. Participants in the intervention group will be participated in 10 sessions of OPC. At the end the questionnaires will be completed by both groups.
- Conditions
- Cerebral Palsy
- Being tested
- occupational performance coaching, standard OT
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occupational performance coachingBehavioural
standard OTBehavioural
| Study group | Role | What they receive |
|---|---|---|
| OT | Active comparator | standard OT Receives: Behavioral: standard OT |
| OT+OPC | Experimental | occupational performance coaching Receives: Behavioral: occupational performance coaching; Behavioral: standard OT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure
It is a questionnaire.
Measured: 10 weeks
Secondary outcomes (1)
Sherer general self-efficacy
It is a questionnaire.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start26 Jul 2016
- Primary completion19 Jan 2017
- Study completion19 Jan 2017
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Welfare and Rehabilitation Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mina ahmadi kahjoogh, University of Social Welfare and Rehabilitation Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915926
- Sponsor's protocol ID
- IR.USWR.REC.1395.148
- Status last verified
- May 2017
- First submitted
- 21 Sep 2016
- Last updated
- 5 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Performance Coaching in Mothers of Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02915926
- Acronym / sponsor ID
- IR.USWR.REC.1395.148
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Social Welfare and Rehabilitation ScienceUniversity, hospital or other
- Study start
- 26 Jul 2016 (actual)
- Primary completion
- 19 Jan 2017 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 27 Sep 2016 (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.
A single-blind Randomized Controlled Trial will be used to test the efficacy of the OPC on self-efficacy and occupational performance with mothers of children with cerebral palsy. Canadian Occupational Performance Measurement and Sherer general self-efficacy scale will be employed to data collection. The sample size was determined for each group of 15 people. The participants conveniently and according to inclusion and exclusion criteria will be randomized into the groups. Participants in the intervention group will be participated in 10 sessions of OPC. At the end the questionnaires will be completed by both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OT | Active comparator | Behavioral: standard OTstandard OT |
| OT+OPC | Experimental | Behavioral: occupational performance coaching, Behavioral: standard OToccupational performance coaching |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- mothers: being literate 25 to 25 caring nobody disabled other than her child children: 5 to 12 cerebral palsy
Key exclusion criteria (1 listed)
- children: others problems that affect on communication
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 |
|---|---|---|
| occupational performance coaching | Behavioural | OT+OPC |
| standard OT | Behavioural | OT, OT+OPC |
Primary outcome
Canadian Occupational Performance Measure
Time frame: 10 weeks
It is a questionnaire.
1 secondary outcome
Sherer general self-efficacy
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occupational performance coaching and standard OT in people with Cerebral Palsy, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (time frame: 10 weeks). 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 5 May 2017.