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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05776576
Other study ID # NAAArman
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 12, 2023
Est. completion date April 15, 2023

Study information

Verified date April 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date April 15, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: 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; - 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. Exclusion Criteria: 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.

Study Design


Intervention

Behavioral:
Evaluation
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.
Education
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.
Other:
Experimentation
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.

Locations

Country Name City State
Turkey Avcilar Belediyesi Gülten Nakipoglu Engelli Yasam Merkezi Istanbul
Turkey Istanbul University-Cerrahpasa Faculty of Health Sciences Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC) The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Change from Baseline Satisfaction Level at 3 months
Primary 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. Change from Baseline Level of Knowledge at 3 months
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