Down Syndrome, Trisomy 21NCT03687619
Cognitive Orientation to Daily Occupational Performance and Conductive Education Approaches on Down Syndrome
A study testing CO-OP and Conductive Education in people with Down Syndrome, Trisomy 21, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
This study will be conducted to investigate and compare the effects of Cognitive Orientation to Daily Occupational Performance (CO-OP) and Conductive Education (CE) on fine motor skills, activity, and participation limitations in children with DS. Children with DS aged 7-18 years will be included. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Down Syndrome, Trisomy 21
- What is being tested?
- CO-OP and Conductive Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCyprus
- Study dates
- 5 Mar 2019to 1 Aug 2020
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged between 7 and 18 years
- Children who can understand cognitive skills given and can verbally communicate
- Children who can specify at least 3 activities
- Children who have adequate motivation
Who cannot join
- Caregivers or parents who have inadequate cognitive levels for the study progression
- Children who participate in any physiotherapy/ergo-therapy schedules for at least 3 months
- Children who have Cognitive Orientation to daily Occupational Performance and Conductive Education program.
- Children who have other neurological problems (except Down Syndrome)
- Children who have undergone orthopedic surgery related to upper limbs
- Children who have other health and behavioral problems which can affect the participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Cognitive Orientation to Daily Occupational Performance and Conductive Education Approaches on Fine Motor Skills, Activity and Participation Limitations in Children With Down Syndrome: Randomized Controlled Trial
This study will be conducted to investigate and compare the effects of Cognitive Orientation to Daily Occupational Performance (CO-OP) and Conductive Education (CE) on fine motor skills, activity, and participation limitations in children with DS. Children with DS aged 7-18 years will be included. Both CO-OP and CE interventions will last 12 weeks and be conducted for 2 sessions per week in the cross-over randomized study. Following 12-week wash-out period, interventions will be changed for each group.
Read the detailed description
Down syndrome (DS) is a chromosomal anomaly characterized by the presence of an extra copy of genetic material on the 21st chromosome. Sensory, motor, cognitive and perceptual impairments can be seen in children with DS. These impairments probably affect the development and learning of their various fundamental and complex actions. Those children experience decreased motor proficiency, reduced social participation and lower life quality.
Fine motor skills are important for children's everyday functioning such as dressing, feeding, bathing, holding objects, cutting etc. In addition, fine motor skills are related to cognitive, social and academic abilities in children.
This study will be conducted to investigate and compare the effects of Cognitive Orientation to Daily Occupational Performance (CO-OP) and Conductive Education (CE) on fine motor skills, activity, and participation limitations in children with DS. Children with DS aged 7-18 years will be included.
Random allocation software will be used to assign CO-OP or CE to participants. Both CO-OP and CE interventions will last 12 weeks and be conducted for 2 sessions per week. Both intervention will be applied as groups including 3-4 children. Following 12-week wash-out period, interventions will be changed for each group. Two meetings before and during the study will be done in order to inform parents about the interventions and their effects. Another investigator who is blind about the groups will conduct the assessments before and after both first and second treatment durations so 4 assessments will be done in total. At the end of whole treatment schedule, a satisfaction form will be asked from the parents for feedback about both interventions.
- Conditions
- Down Syndrome, Trisomy 21
- Being tested
- CO-OP, Conductive Education
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO-OPOther
Interventions (from top to down) related to the development of fine-motor skills
Conductive EducationOther
Interventions (from down to top) related to the development of fine-motor skills
| Study group | Role | What they receive |
|---|---|---|
| CO-OP | Experimental | Cognitive Orientation to daily Occupational Performance (CO-OP) is a top-down approach. This programme will be conducted as a small group. Each group will averagely have 5 children. The primary investigator will conduct the programmes. It will be one hour session, twice a week, 12 weeks. Receives: Other: CO-OP |
| Conductive Education | Experimental | Conductive Education is a down-top approach. This programme will be conducted as a small group. Each group will averagely have 5 children. The primary investigator will conduct the programmes. It will be one hour session, twice a week, 12 weeks. Receives: Other: Conductive Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance quality rating scale
The PQRS rates performance quality on a 10-point scale, with a score of 1 indicating ''can't do the skill at all'' and 10 indicating ''does the skill very well''. An independent observer rates performances from video recorded trials of each skill at all assessment points.
Measured: 12 weeks
Secondary outcomes (7)
Nine Hole Peg Test
The Nine-Hole Peg Test is a timed dexterity test that evaluates the ability to pick up nine 1¼-inch-long plastic pegs from a shallow dish, place them one at a time into a pegboard, and remove them one at a time back into the dish. The total time to complete the task for each hand will be recorded in seconds.
Measured: 12 weeks
Bruininks-Oseretsky Motor Proficiency Test - Brief Form
It will be used to determine the motor skills of the children. Bilateral coordination, balance, strength and speed-agility will be measured to specify gross motor skills, while fine motor precision, fine motor integration, manual dexterity, and upper limb coordination will be measured for fine motor skills.
Measured: 12 weeks
Canadian Occupational Performance Measure
The COPM is an outcome measure that, through a semi-structured interview, is designed to (a) identify and prioritize occupational performance issues or goals, and (b) measure clients' self perceived changes in occupational performance and satisfaction with their performance over time, of identified goals.
Measured: 12 weeks
Dynamic Performance Analysis
DPA is a dynamic, iterative process, carried out as the client performs the occupation. The purpose of DPA is to identify where performance breaks down and test out solutions.This analysis will be used within the concept of CO-OP.
Measured: 12 weeks
Child Health Questionnaire- Parent Form
The CHQ PF-50 is a 50 item, parent-completed questionnaire designed to measure the physical and psychosocial well-being of children with and without chronic conditions. Reliability and validity of Turkish version have been shown. The CHQ PF-50 measures components of physical and psychosocial functioning in 12 categories (subscales). The subscales used for our analyses included: physical functioning, role/social limitations (note: we call this subscale "School \& Friends" since it measures the degree to which schoolwork or activities with friends are limited due to problems with physical health), bodily pain/ discomfort, mental health, and self-esteem.
Measured: 12 weeks
Goal Attainment Scaling
The goal attainment scale is characterised by five levels of achievement. The expected outcome is the middle or 'zero' score. This expected outcome is determined first and then two better and two worse outcomes are documented. It enables individualised goals to be set and allows measurement of clinically important change which may not be detected by standardised assessments
Measured: 12 weeks
Parent Satisfaction Form
It is a semi-structured questionnaire which will indicate the satisfaction level of parents from both approaches.
Measured: 12 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 2018
- Study start5 Mar 2019
- Primary completion22 Dec 2019
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down Syndrome, Trisomy 21Studies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Özbeşer, Eastern Mediterranean University
- Investigators
- Emine H. Tüzün, Prof. Dr., Principal investigator, InstructorHülya Özbeşer, MSc. PT, Principal investigator, InstructorLevent Eker, M. D., Principal investigator, Instructor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687619
- Sponsor's protocol ID
- ETK00-218-0213
- Status last verified
- Aug 2020
- First submitted
- 26 Sep 2018
- Last updated
- 6 Aug 2020
- 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 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cognitive Orientation to Daily Occupational Performance and Conductive Education Approaches on Fine Motor Skills, Activity and Participation Limitations in Children With Down Syndrome: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03687619
- Acronym / sponsor ID
- ETK00-218-0213
- Conditions
- Down Syndrome, Trisomy 21
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 22 Dec 2019 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 27 Sep 2018 (actual)
- 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.
This study will be conducted to investigate and compare the effects of Cognitive Orientation to Daily Occupational Performance (CO-OP) and Conductive Education (CE) on fine motor skills, activity, and participation limitations in children with DS. Children with DS aged 7-18 years will be included. Both CO-OP and CE interventions will last 12 weeks and be conducted for 2 sessions per week in the cross-over randomized study. Following 12-week wash-out period, interventions will be changed for each group.
Detailed description
Down syndrome (DS) is a chromosomal anomaly characterized by the presence of an extra copy of genetic material on the 21st chromosome. Sensory, motor, cognitive and perceptual impairments can be seen in children with DS. These impairments probably affect the development and learning of their various fundamental and complex actions. Those children experience decreased motor proficiency, reduced social participation and lower life quality.
Fine motor skills are important for children's everyday functioning such as dressing, feeding, bathing, holding objects, cutting etc. In addition, fine motor skills are related to cognitive, social and academic abilities in children.
This study will be conducted to investigate and compare the effects of Cognitive Orientation to Daily Occupational Performance (CO-OP) and Conductive Education (CE) on fine motor skills, activity, and participation limitations in children with DS. Children with DS aged 7-18 years will be included.
Random allocation software will be used to assign CO-OP or CE to participants. Both CO-OP and CE interventions will last 12 weeks and be conducted for 2 sessions per week. Both intervention will be applied as groups including 3-4 children. Following 12-week wash-out period, interventions will be changed for each group. Two meetings before and during the study will be done in order to inform parents about the interventions and their effects. Another investigator who is blind about the groups will conduct the assessments before and after both first and second treatment durations so 4 assessments will be done in total. At the end of whole treatment schedule, a satisfaction form will be asked from the parents for feedback about both interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO-OP | Experimental | Other: CO-OPCognitive Orientation to daily Occupational Performance (CO-OP) is a top-down approach. This programme will be conducted as a small group. Each group will averagely have 5 children. The primary investigator will conduct the programmes. It will be one hour session, twice a week, 12 weeks. |
| Conductive Education | Experimental | Other: Conductive EducationConductive Education is a down-top approach. This programme will be conducted as a small group. Each group will averagely have 5 children. The primary investigator will conduct the programmes. It will be one hour session, twice a week, 12 weeks. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children aged between 7 and 18 years
- Children who can understand cognitive skills given and can verbally communicate
- Children who can specify at least 3 activities
- Children who have adequate motivation
Key exclusion criteria (6 listed)
- Caregivers or parents who have inadequate cognitive levels for the study progression
- Children who participate in any physiotherapy/ergo-therapy schedules for at least 3 months
- Children who have Cognitive Orientation to daily Occupational Performance and Conductive Education program.
- Children who have other neurological problems (except Down Syndrome)
- Children who have undergone orthopedic surgery related to upper limbs
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 |
|---|---|---|
| CO-OPInterventions (from top to down) related to the development of fine-motor skills | Other | CO-OP |
| Conductive EducationInterventions (from down to top) related to the development of fine-motor skills | Other | Conductive Education |
Primary outcome
performance quality rating scale
Time frame: 12 weeks
The PQRS rates performance quality on a 10-point scale, with a score of 1 indicating ''can't do the skill at all'' and 10 indicating ''does the skill very well''. An independent observer rates performances from video recorded trials of each skill at all assessment points.
7 secondary outcomes
Nine Hole Peg Test
Time frame: 12 weeks
Bruininks-Oseretsky Motor Proficiency Test - Brief Form
Time frame: 12 weeks
Canadian Occupational Performance Measure
Time frame: 12 weeks
Dynamic Performance Analysis
Time frame: 12 weeks
Child Health Questionnaire- Parent Form
Time frame: 12 weeks
Goal Attainment Scaling
Time frame: 12 weeks
Parent Satisfaction Form
Time frame: 12 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 6 Aug 2020.
Related trials for Down Syndrome, Trisomy 21
Active, not recruitingPhase 3
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma
Not yet recruiting
Executive Function Play Opportunities for Children With Down Syndrome
Down Syndrome, Trisomy 21
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
Down Syndrome, Turner Syndrome
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
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.
Emine H. Tüzün, Prof. Dr. principal investigator
Instructor
Hülya Özbeşer, MSc. PT principal investigator
Instructor
Levent Eker, M. D. principal investigator
Instructor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO-OP and Conductive Education in people with Down Syndrome, Trisomy 21, run by Eastern Mediterranean University at 1 site in Cyprus.
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 4 inclusion and 6 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 6 Aug 2020. 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 Cyprus. 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?
performance quality rating scale (time frame: 12 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 6 Aug 2020.