Adolescent BehaviorNCT05776576
Physical Activity and Recreation School Program for Special Needs Individuals and Their Parents
An observational study of Adolescent Behavior and Children, Only, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial summary
The general purpose of this project; "Physical Activity and Recreation School" for the evaluation of physical activity behaviors of individuals with physical disabilities between the ages of 6-18, to increase the level of knowledge and awareness of these individuals and their parents, and to enable individuals with… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Children, Only, Child Behavior Problem
- What is being tested?
- Evaluation, Education and Experimentation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 12 Jan 2023to 15 Apr 2023
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Individuals with special needs between the ages of 6-18 with physical disabilities and their families
Who may be able to join
- For Individuals with special needs;
- Between the ages of 6-18
- Being diagnosed with Cerebral Palsy, Neuromuscular Muscle Disease, Spina Bifida or having a chronic neurological or orthopedic problem that causes physical disability
- Being in a wheelchair/ able to walk with an assistive device or independently
- Have a cognitive level to understand and communicate questions
- Being residing in the province of Istanbul For parents of individuals with special needs;
Show all 11Show fewer
- Being the mother or father of a special needs child or adolescent
- Volunteering for a special needs child to participate in the study
- Being able to participate in the activities to be held within the scope of the project on a full-time basis
- Have a cognitive level to understand and communicate questions
- Using a smart phone.
Who cannot join
- For Individuals with special needs;
- Having a cognitive problem that will prevent the application of the evaluation parameters
- Failure to approve the assessment by the custodial parent
- Having had lower extremity surgery in the last 6 months
- Doing regular physical activity in the last 6 months
- Being a professional athlete For parents of individuals with special needs;
- Being illiterate.
- Not living with a special needs child.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Avcılar Belediyesi Gülten Nakipoğlu Engelli Yaşam Merkezi
Istanbul
Istanbul University-Cerrahpaşa Faculty of Health Sciences
Istanbul
About this study
Official title: Physical Activity and Recreation School Program for Special Needs Individuals With Physical Disabilities and Their Parents
The general purpose of this project; "Physical Activity and Recreation School" for the evaluation of physical activity behaviors of individuals with physical disabilities between the ages of 6-18, to increase the level of knowledge and awareness of these individuals and their parents, and to enable individuals with special needs to experience sports activities in the company of health and sports professionals who are experts in their fields. is to arrange. This project consists of three main topics as evaluation, training and experimentation.
During the evaluation phase, interactive roundtable activity, valid and reliable scales and physical assessments, and barriers and motivators for physical activity participation of individuals with special needs will be evaluated. A comprehensive interactive training seminar on physical activity will be held for individuals with special needs and parents during the training phase.
In the experimentation phase, children and adolescents with special needs will participate in training programs that include exercise and sportive activities suitable for the determined physical activity barriers and motivators, and will have the opportunity to experience exercises and sportive activities that they have not experienced before. The results of this project will provide gains in the analysis and application of physical inactivity, which is seen as an important public health problem in our country, for individuals with special needs, and will also guide many relevant institutions, health professionals and educators.
- Conditions
- Adolescent Behavior, Children, Only, Child Behavior Problem
- Being tested
- Evaluation, Education, Experimentation
- Keywords
- Physical Inactivity, Physical Disability, Adolescent Behavior, Children, Only, Child Behavior Problem
- Medical subject headings
- Adolescent Behavior, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationBehavioural
Within the scope of the evaluation, first of all, physical activity levels of children and adolescents with physical disabilities, barriers that prevent them from participating in physical activity, and motivators that can increase their participation will be determined, accompanied by an interactive roundtable meeting. Afterwards, posture analyzes of children and adolescents with special needs with physical disabilities will be performed by physiotherapists.
EducationBehavioural
In the education part, interactive informative seminars titled "Physical Activity in Individuals with Special Needs" will be given and after the objective posture assessments, postural disorders of children and adolescents with special needs will be determined and accordingly, posture and ergonomics training will be given to the participants individually.
ExperimentationOther
In the experimentation part, group exercises, dance therapy programs and technology-supported exercise educations with various technological equipment will be implemented in the company of physiotherapists, taking into account the posture assessments.
| Study group | Role | What they receive |
|---|---|---|
| Special needs children and adolescents with physical disabilities and their parents | Project consists of three main stages as evaluation, education and experimentation. For evaluation, firstly physical activity levels of individuals with special needs, barriers in physical activity, and motivators will be determined with an interactive roundtable meeting with children, adolescents and their parents. Afterwards, posture analyzes of individuals with special needs will be performed by physiotherapists. For education, interactive informative seminars titled "Physical Activity in Individuals with Special Needs" will be given and after that posture and ergonomics education will be given to the participants individually. For experimentation, group exercises, dance therapy and technology-supported exercise educations will be implemented by physiotherapists, taking into account the previous evaluations. Receives: Behavioral: Evaluation; Behavioral: Education; Other: Experimentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observational Posture Analysis
Observational posture assessment will be made from the front, back and both sides of children and adolescents with physical disabilities while sitting or standing.
Measured: Baseline
Physical Activity Participation Motivation Scale
The lowest score that can be obtained from the scale is 16, and the highest score is 80. The high scores of the participants on the scale mean that their motivation to participate in physical activity is positive.
Measured: Baseline
Motivation Scale for Participation in Sports for Persons with Disabilities
The scale consists of 22 items and three sub-dimensions (intrinsic motivation, extrinsic motivation and amotivation). The scale, which was developed to reveal the sources of the motivations of the participants that cause them to do sports, is in the form of a 5-point Likert type. The answer options for the items in the 5-point Likert scale are "1=Strongly Disagree", "2=Partially Disagree", "3=Moderately Agree", "4=Agree", "5=Strongly Agree". Since the scores in the scale are between 1 and 5, the higher the propositions in the items, the higher the motivation level of students to participate in sports; The closer it is to 1, the lower it is considered.
Measured: Baseline
Life Satisfaction Scale in Children
This scale consists of 5 questions in a 5-point Likert type (I strongly disagree 1, I strongly disagree 2, I am undecided 3, I somewhat agree 4, I completely agree 5) and it has a single factor structure.
Measured: Baseline
Satisfaction Level
During and after the education, the level of satisfaction obtained by the parents thanks to the educational seminar will be evaluated with a 3-5 question questionnaire prepared by the project team. In addition, the satisfaction level of the participants will be evaluated with a numerical rating scale after each education and experimentation through Google Forms. This scale consists of numbers ranging from "0" to "10" points. Individuals will be asked to rate their satisfaction level with the best satisfaction level as "10" points and the worst satisfaction level with "0" points.
Measured: Change from Baseline Satisfaction Level at 3 months
Level of Knowledge
During and after the education, the level of knowledge gained by the parents through the educational seminar will be evaluated with a 3-5 question questionnaire prepared by the project team. In addition, the knowledge level of the participants will be evaluated with a numerical rating scale after each education and experimentation through Google Forms. This scale consists of numbers ranging from "0" to "10" points. Individuals will be asked to rate their level of knowledge with the best knowledge level as "10" points and the worst knowledge level with "0" points.
Measured: Change from Baseline Level of Knowledge at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start12 Jan 2023
- Primary completion30 Mar 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies 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
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Nilay Arman, Istanbul University - Cerrahpasa
- Investigators
- Nilay Arman, Assoc. Prof., Principal investigator, Istanbul University-Cerrahpaşa, Department of Physiotherapy and Rehabilitationİpek Yeldan, Prof., Study chair, Istanbul University-Cerrahpaşa, Department of Physiotherapy and RehabilitationAsena Yekdaneh, Pt., MSc., Study chair, Istanbul University-Cerrahpasa Institute of Postgraduate EducationElçin Akyürek, Pt., MSc., Study chair, Istanbul University-Cerrahpasa Institute of Postgraduate Educationİrem Kurt, Pt., MSc., Study chair, Istanbul University-Cerrahpasa Institute of Postgraduate EducationTuğçe Poyraz, Pt., MSc., Study chair, Istanbul University-Cerrahpasa Institute of Postgraduate Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776576
- Sponsor's protocol ID
- NAAArman
- Status last verified
- Apr 2023
- First submitted
- 25 Feb 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Recreation School Program for Special Needs Individuals With Physical Disabilities and Their Parents
- ClinicalTrials.gov ID
- NCT05776576
- Acronym / sponsor ID
- NAAArman
- Conditions
- Adolescent Behavior, Children, Only, Child Behavior Problem
- Keywords
- Physical Inactivity, Physical Disability, Adolescent Behavior, Children, Only, Child Behavior Problem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 20 Mar 2023 (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 general purpose of this project; "Physical Activity and Recreation School" for the evaluation of physical activity behaviors of individuals with physical disabilities between the ages of 6-18, to increase the level of knowledge and awareness of these individuals and their parents, and to enable individuals with special needs to experience sports activities in the company of health and sports professionals who are experts in their fields. is to arrange. This project consists of three main topics as evaluation, training and experimentation.
During the evaluation phase, interactive roundtable activity, valid and reliable scales and physical assessments, and barriers and motivators for physical activity participation of individuals with special needs will be evaluated. A comprehensive interactive training seminar on physical activity will be held for individuals with special needs and parents during the training phase.
In the experimentation phase, children and adolescents with special needs will participate in training programs that include exercise and sportive activities suitable for the determined physical activity barriers and motivators, and will have the opportunity to experience exercises and sportive activities that they have not experienced before. The results of this project will provide gains in the analysis and application of physical inactivity, which is seen as an important public health problem in our country, for individuals with special needs, and will also guide many relevant institutions, health professionals and educators.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Special needs children and adolescents with physical disabilities and their parents | – | Behavioral: Evaluation, Behavioral: Education, Other: ExperimentationProject consists of three main stages as evaluation, education and experimentation. For evaluation, firstly physical activity levels of individuals with special needs, barriers in physical activity, and motivators will be determined with an interactive roundtable meeting with children, adolescents and their parents. Afterwards, posture analyzes of individuals with special needs will be performed by physiotherapists. For education, interactive informative seminars titled "Physical Activity in Individuals with Special Needs" will be given and after that posture and ergonomics education will be given to the participants individually. For experimentation, group exercises, dance therapy and technology-supported exercise educations will be implemented by physiotherapists, taking into account the previous evaluations. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Individuals with special needs between the ages of 6-18 with physical disabilities and their families
Key inclusion criteria (11 listed)
- For Individuals with special needs;
- Between the ages of 6-18
- Being diagnosed with Cerebral Palsy, Neuromuscular Muscle Disease, Spina Bifida or having a chronic neurological or orthopedic problem that causes physical disability
- Being in a wheelchair/ able to walk with an assistive device or independently
- Have a cognitive level to understand and communicate questions
Key exclusion criteria (8 listed)
- For Individuals with special needs;
- Having a cognitive problem that will prevent the application of the evaluation parameters
- Failure to approve the assessment by the custodial parent
- Having had lower extremity surgery in the last 6 months
- Doing regular physical activity in the last 6 months
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 |
|---|---|---|
| EvaluationWithin the scope of the evaluation, first of all, physical activity levels of children and adolescents with physical disabilities, barriers that prevent them from participating in physical activity, and motivators that can increase their participation will be determined, accompanied by an interactive roundtable meeting. Afterwards, posture analyzes of children and adolescents with special needs with physical disabilities will be performed by physiotherapists. | Behavioural | Special needs children and adolescents with physical disabilities and their parents |
| EducationIn the education part, interactive informative seminars titled "Physical Activity in Individuals with Special Needs" will be given and after the objective posture assessments, postural disorders of children and adolescents with special needs will be determined and accordingly, posture and ergonomics training will be given to the participants individually. | Behavioural | Special needs children and adolescents with physical disabilities and their parents |
| ExperimentationIn the experimentation part, group exercises, dance therapy programs and technology-supported exercise educations with various technological equipment will be implemented in the company of physiotherapists, taking into account the posture assessments. | Other | Special needs children and adolescents with physical disabilities and their parents |
Primary outcome
Observational Posture Analysis
Time frame: Baseline
Observational posture assessment will be made from the front, back and both sides of children and adolescents with physical disabilities while sitting or standing.
Physical Activity Participation Motivation Scale
Time frame: Baseline
The lowest score that can be obtained from the scale is 16, and the highest score is 80. The high scores of the participants on the scale mean that their motivation to participate in physical activity is positive.
Motivation Scale for Participation in Sports for Persons with Disabilities
Time frame: Baseline
The scale consists of 22 items and three sub-dimensions (intrinsic motivation, extrinsic motivation and amotivation). The scale, which was developed to reveal the sources of the motivations of the participants that cause them to do sports, is in the form of a 5-point Likert type. The answer options for the items in the 5-point Likert scale are "1=Strongly Disagree", "2=Partially Disagree", "3=Moderately Agree", "4=Agree", "5=Strongly Agree". Since the scores in the scale are between 1 and 5, the higher the propositions in the items, the higher the motivation level of students to participate in sports; The closer it is to 1, the lower it is considered.
Life Satisfaction Scale in Children
Time frame: Baseline
This scale consists of 5 questions in a 5-point Likert type (I strongly disagree 1, I strongly disagree 2, I am undecided 3, I somewhat agree 4, I completely agree 5) and it has a single factor structure.
Satisfaction Level
Time frame: Change from Baseline Satisfaction Level at 3 months
During and after the education, the level of satisfaction obtained by the parents thanks to the educational seminar will be evaluated with a 3-5 question questionnaire prepared by the project team. In addition, the satisfaction level of the participants will be evaluated with a numerical rating scale after each education and experimentation through Google Forms. This scale consists of numbers ranging from "0" to "10" points. Individuals will be asked to rate their satisfaction level with the best satisfaction level as "10" points and the worst satisfaction level with "0" points.
Level of Knowledge
Time frame: Change from Baseline Level of Knowledge at 3 months
During and after the education, the level of knowledge gained by the parents through the educational seminar will be evaluated with a 3-5 question questionnaire prepared by the project team. In addition, the knowledge level of the participants will be evaluated with a numerical rating scale after each education and experimentation through Google Forms. This scale consists of numbers ranging from "0" to "10" points. Individuals will be asked to rate their level of knowledge with the best knowledge level as "10" points and the worst knowledge level with "0" points.
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 28 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Nilay Arman, Assoc. Prof. principal investigator
Istanbul University-Cerrahpaşa, Department of Physiotherapy and Rehabilitation
İpek Yeldan, Prof. study chair
Istanbul University-Cerrahpaşa, Department of Physiotherapy and Rehabilitation
Asena Yekdaneh, Pt., MSc. study chair
Istanbul University-Cerrahpasa Institute of Postgraduate Education
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Behavior and Children, Only, run by Istanbul University - Cerrahpasa at 2 sites 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 11 inclusion and 8 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Observational Posture Analysis (time frame: Baseline). The study lists 6 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 28 Apr 2023.