Down SyndromeNCT05152251
Activities and Participation of Children With Down Syndrome
An observational study of Down Syndrome and Activity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the activity participation levels of Down syndrome(DS) children and the restrictive or supportive factors affecting their participation levels and to investigate their effects on quality of life. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome, Activity, Participation
- What is being tested?
- Evaluation
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 1 Nov 2022
- Phase
- Observational
- 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 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will include children with DS between the ages of 8-17, who can cooperate, who are not visually and/or hearing impaired, and typically developing children between the ages of 8-17 who are not diagnosed with any disease, and their literate parents.
Who may be able to join
- Children with DS aged 8-17 years, who can cooperate, who have no visual and/or hearing impairment
- Typical developing children aged 8-17 years who are not diagnosed with any disease
- Parents who can read and write
Who cannot join
- Children and their families who did not want to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Sciences University
Ankara
Duygu Türker, PhD, duyguturker@yahoo.com
Duygu TÜRKER
About this study
Official title: Investigation of Activity and Participation Levels in Children With Down Syndrome
The aim of this study is to examine the activity participation levels of Down syndrome(DS) children and the restrictive or supportive factors affecting their participation levels and to investigate their effects on quality of life. 35 children diagnosed with DS by a pediatric neurologist and 35 typically developing children are planned to be included in this study. Sociodemographic data of typically developing and DS children who agreed to participate in the study and their families will be questioned. Activity (Gross Motor Function Measurement-GMFM-88) , participation and the effect of the environment on participation (Participation and Environment Measure for Children and Youth-PEM-CY ), reflection of motor development levels to functions in daily living activities (Pediatric Evaluation of Disability Inventory- PEDI) , quality of life(Pediatric Quality of Life Inventory- PedsQL) and familial impact (Impact on Family Scale-IPFAM) will be evaluated. Evaluation methods to be used in our study will be applied one-on-one with children and face-to-face interviews with their parents. Our study is important in that there is little evidence on participation studies in children and that changing medical paradigms emphasize the quality of life of children. In addition, the PEM-CY the investigators will use in the study will make the study more valuable as it examines the effect of the environment on participation and evaluates participation in different environments.
Read the detailed description
The aim of this study is to examine the activity participation levels of DS children and the restrictive or supportive factors affecting their participation levels and to investigate their effects on quality of life. 35 children diagnosed with DS by a pediatric neurologist and 35 typically developing children are planned to be included in this study. In line with the power analysis, a study should be conducted with a total of 52 individuals, 26 individuals in each group, with 95% confidence (1-α), 95.0% test power (1-β) and d=1.50 (large) effect size . Considering the 25% loss of individuals in the groups during the evaluation period, it was decided that forming each group with at least 35 children would increase the power of the study, and the study will be concluded with at least 70 individuals.Sociodemographic data of typically developing and DS children who agreed to participate in the study and their families will be questioned. Sociodemographic data will include information about age, height, weight, gender, body mass index, education level of the child, place of residence, physical therapy and special education session received by the child, assistive devices used, comorbidities of the child (cardiovascular anomalies, pulmonary problems, oral disorders, gastrointestinal disorders, overweight and obesity, musculoskeletal disorders, epilepsy), age of parents, education level, occupation, marital status, average income . Activity (Gross Motor Function Measurement-GMFM-88) , participation and the effect of the environment on participation (Participation and Environment Measure for Children and Youth -PEM-CY), reflection of motor development levels to functions in daily living activities (Pediatric Evaluation of Disability Inventory- PEDI) , quality of life(Pediatric Quality of Life Inventory- PedsQL) and familial impact (Impact on Family Scale-IPFAM) will be evaluated. Evaluation methods to be used in our study will be applied one-on-one with children and face-to-face interviews with their parents. The data to be obtained from the study will be analyzed using appropriate statistical methods. Statistical analyzes will be made using the Windows compatible Statistical Package for Social Science(SPSS) 20.0 package program. Data indicated by measurement will be expressed as arithmetic mean and standard deviation, data indicated by counting will be expressed as n and percentage (n,%). In the comparison of the groups, the t test will be used when parametric conditions are met, and the Mann Whitney U test will be used in cases where they are not met. The P value will be taken as 0.05. The investigators think that the results of the study can provide a new perspective to clinicians and researchers working in the field of rehabilitation in order to support the participation of DS children and young people in social life and can support social support projects and policies.
- Conditions
- Down Syndrome, Activity, Participation, Quality of Life
- Being tested
- Evaluation
- Medical subject headings
- Down Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
Individuals' activity participation levels and the restrictive or supportive factors affecting their participation levels and their effects on quality of life will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Down Syndrome Receives: Other: Evaluation | |
| Control Group | Typically Developing Children Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measurement-88(GMFM-88)
The measurement assesses gross motor functions in children aged 5 months to 16 years.Although GMFM-88 was developed for children with Cerebral palsy (CP), it has also been validated for other populations such as children with DS and acquired brain injury.GMFM-88 consists of 88 items in total, including supine-prone position and rolling (A=17), sitting (B=20), crawling-kneeling (C=14), standing (D=13), walking-running-jumping (E=24) subsections. Gross motor functions in these items are evaluated according to the degree of achievement. Scoring is done according to the Likert scale: 0 means that the activity has never been started, and 3 means that 90% - 100% of the activity can be done.
Measured: The measurements will start with the first child with DS (estimated in November 2021) and will end with the evaluation of the 35th child(estimated in May 2022).
Participation and Environment Measure for Children and Youth(PEM-CY)
The PEM-CY is a parent report questionnaire used to assess participation and environmental factors in children and adolescents aged 5-17 years at home, at school, and in community settings. Items for each environment generally represent the types of activities performed in that setting; The engagement sections include 10 activities in the home environment, 5 activities in the school environment, and 10 activities in the community setting.For each type of activity, the parent is asked to rate how often (for the last 4 months) the child participates (eight options: daily to never), how much the child is typically involved during participation on a 5-point Likert scale, and whether the parent would like to see the child participate in this type of activity change.After answering the participation section, parents are asked to rate environmental features to identify supports and barriers.
Measured: The measurements will start with the first child (estimated in November 2021) and will end with the evaluation of the 70th child(estimated in May 2022).
Pediatric Evaluation of Disability Inventory(PEDI)
PEDI comprehensively assesses functional ability and performance in children with disabilities. The functional skills section, which measures the functional abilities of the child, consists of a total of 197 items including the Self-Care (73), Mobility (59) and Social Function (65) subscales. Rating 0; cannot and 1; is done as can be done. At the end of each sub-scale, the scores of that scale are summed up and the Functional Skills Total Score is obtained by adding the scores of the sub-scales.
Measured: The measurements will start with the first child with DS (estimated in November 2021) and will end with the evaluation of the 35th child(estimated in May 2022).
Secondary outcomes (2)
Pediatric Quality of Life Inventory(PedsQL)
It is a general quality of life scale that evaluates the physical and psychosocial lives of children between the ages of 2-18 independently of the disease. The scale, prepared for the 8-12 and 13-18 age groups, has a parent and child form. Scoring of the 23-item scale, which is suitable for use in both healthy and diseased children and adolescents, is done in 3 areas (total score, physical health, emotional social school functionality). The higher the total score, the better the health-related quality of life is perceived.
Measured: The measurements will start with the first child (estimated in November 2021) and will end with the evaluation of the 70th child(estimated in May 2022).
Impact on Family Scale(IPFAM)
It was developed to easily measure the impact on the families of children with chronic disabilities. It evaluates the level of influence of the family under 4 main headings: financial burden, familial and social impact, personal difficulty, coping, and the total impact score can be calculated by the sum of these parameters. The scale has a 4-point Likert type evaluation. A minimum of 24 and a maximum of 96 points can be obtained from the scale.
Measured: The measurements will start with the first child with DS (estimated in November 2021) and will end with the evaluation of the 35th child(estimated in May 2022).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Feb 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Turker, Hacettepe University
- Investigators
- Duygu Türker, PhD,PT, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152251
- Sponsor's protocol ID
- 2021-365
- Status last verified
- May 2022
- First submitted
- 29 Nov 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Activity and Participation Levels in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05152251
- Acronym / sponsor ID
- 2021-365
- Conditions
- Down Syndrome, Activity, Participation, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 9 Dec 2021 (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.
The aim of this study is to examine the activity participation levels of Down syndrome(DS) children and the restrictive or supportive factors affecting their participation levels and to investigate their effects on quality of life. 35 children diagnosed with DS by a pediatric neurologist and 35 typically developing children are planned to be included in this study. Sociodemographic data of typically developing and DS children who agreed to participate in the study and their families will be questioned. Activity (Gross Motor Function Measurement-GMFM-88) , participation and the effect of the environment on participation (Participation and Environment Measure for Children and Youth-PEM-CY ), reflection of motor development levels to functions in daily living activities (Pediatric Evaluation of Disability Inventory- PEDI) , quality of life(Pediatric Quality of Life Inventory- PedsQL) and familial impact (Impact on Family Scale-IPFAM) will be evaluated. Evaluation methods to be used in our study will be applied one-on-one with children and face-to-face interviews with their parents. Our study is important in that there is little evidence on participation studies in children and that changing medical paradigms emphasize the quality of life of children. In addition, the PEM-CY the investigators will use in the study will make the study more valuable as it examines the effect of the environment on participation and evaluates participation in different environments.
Detailed description
The aim of this study is to examine the activity participation levels of DS children and the restrictive or supportive factors affecting their participation levels and to investigate their effects on quality of life. 35 children diagnosed with DS by a pediatric neurologist and 35 typically developing children are planned to be included in this study. In line with the power analysis, a study should be conducted with a total of 52 individuals, 26 individuals in each group, with 95% confidence (1-α), 95.0% test power (1-β) and d=1.50 (large) effect size . Considering the 25% loss of individuals in the groups during the evaluation period, it was decided that forming each group with at least 35 children would increase the power of the study, and the study will be concluded with at least 70 individuals.Sociodemographic data of typically developing and DS children who agreed to participate in the study and their families will be questioned. Sociodemographic data will include information about age, height, weight, gender, body mass index, education level of the child, place of residence, physical therapy and special education session received by the child, assistive devices used, comorbidities of the child (cardiovascular anomalies, pulmonary problems, oral disorders, gastrointestinal disorders, overweight and obesity, musculoskeletal disorders, epilepsy), age of parents, education level, occupation, marital status, average income . Activity (Gross Motor Function Measurement-GMFM-88) , participation and the effect of the environment on participation (Participation and Environment Measure for Children and Youth -PEM-CY), reflection of motor development levels to functions in daily living activities (Pediatric Evaluation of Disability Inventory- PEDI) , quality of life(Pediatric Quality of Life Inventory- PedsQL) and familial impact (Impact on Family Scale-IPFAM) will be evaluated. Evaluation methods to be used in our study will be applied one-on-one with children and face-to-face interviews with their parents. The data to be obtained from the study will be analyzed using appropriate statistical methods. Statistical analyzes will be made using the Windows compatible Statistical Package for Social Science(SPSS) 20.0 package program. Data indicated by measurement will be expressed as arithmetic mean and standard deviation, data indicated by counting will be expressed as n and percentage (n,%). In the comparison of the groups, the t test will be used when parametric conditions are met, and the Mann Whitney U test will be used in cases where they are not met. The P value will be taken as 0.05. The investigators think that the results of the study can provide a new perspective to clinicians and researchers working in the field of rehabilitation in order to support the participation of DS children and young people in social life and can support social support projects and policies.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: EvaluationDown Syndrome |
| Control Group | – | Other: EvaluationTypically Developing Children |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will include children with DS between the ages of 8-17, who can cooperate, who are not visually and/or hearing impaired, and typically developing children between the ages of 8-17 who are not diagnosed with any disease, and their literate parents.
Key inclusion criteria (3 listed)
- Children with DS aged 8-17 years, who can cooperate, who have no visual and/or hearing impairment
- Typical developing children aged 8-17 years who are not diagnosed with any disease
- Parents who can read and write
Key exclusion criteria (1 listed)
- Children and their families who did not want to participate in the study
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 |
|---|---|---|
| EvaluationIndividuals' activity participation levels and the restrictive or supportive factors affecting their participation levels and their effects on quality of life will be evaluated. | Other | Control Group, Study Group |
Primary outcome
Gross Motor Function Measurement-88(GMFM-88)
Time frame: The measurements will start with the first child with DS (estimated in November 2021) and will end with the evaluation of the 35th child(estimated in May 2022).
The measurement assesses gross motor functions in children aged 5 months to 16 years.Although GMFM-88 was developed for children with Cerebral palsy (CP), it has also been validated for other populations such as children with DS and acquired brain injury.GMFM-88 consists of 88 items in total, including supine-prone position and rolling (A=17), sitting (B=20), crawling-kneeling (C=14), standing (D=13), walking-running-jumping (E=24) subsections. Gross motor functions in these items are evaluated according to the degree of achievement. Scoring is done according to the Likert scale: 0 means that the activity has never been started, and 3 means that 90% - 100% of the activity can be done.
Participation and Environment Measure for Children and Youth(PEM-CY)
Time frame: The measurements will start with the first child (estimated in November 2021) and will end with the evaluation of the 70th child(estimated in May 2022).
The PEM-CY is a parent report questionnaire used to assess participation and environmental factors in children and adolescents aged 5-17 years at home, at school, and in community settings. Items for each environment generally represent the types of activities performed in that setting; The engagement sections include 10 activities in the home environment, 5 activities in the school environment, and 10 activities in the community setting.For each type of activity, the parent is asked to rate how often (for the last 4 months) the child participates (eight options: daily to never), how much the child is typically involved during participation on a 5-point Likert scale, and whether the parent would like to see the child participate in this type of activity change.After answering the participation section, parents are asked to rate environmental features to identify supports and barriers.
Pediatric Evaluation of Disability Inventory(PEDI)
Time frame: The measurements will start with the first child with DS (estimated in November 2021) and will end with the evaluation of the 35th child(estimated in May 2022).
PEDI comprehensively assesses functional ability and performance in children with disabilities. The functional skills section, which measures the functional abilities of the child, consists of a total of 197 items including the Self-Care (73), Mobility (59) and Social Function (65) subscales. Rating 0; cannot and 1; is done as can be done. At the end of each sub-scale, the scores of that scale are summed up and the Functional Skills Total Score is obtained by adding the scores of the sub-scales.
2 secondary outcomes
Pediatric Quality of Life Inventory(PedsQL)
Time frame: The measurements will start with the first child (estimated in November 2021) and will end with the evaluation of the 70th child(estimated in May 2022).
Impact on Family Scale(IPFAM)
Time frame: The measurements will start with the first child with DS (estimated in November 2021) and will end with the evaluation of the 35th child(estimated in May 2022).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
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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.
Duygu Türker, PhD,PT principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome and Activity, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 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: status not confirmed, as of the sponsor's last update on 26 May 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duygu Türker, PhD, PT (5304602723, duyguturker@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measurement-88(GMFM-88) (time frame: The measurements will start with the first child with DS (estimated in November 2021) and will end with the evaluation of the 35th child(estimated in May 2022).). The study lists 3 primary outcomes in all. 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 26 May 2022.