- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05998083
The Effectiveness of Purposeful Exercises in Children Diagnosed With Special Learning Disabilities
Investigation of the Effect of Purposeful Balance and Coordination Exercises on Attention and Quality of Life in Children Diagnosed With Special Learning Disabilities.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey
- Özel Eğitim Merkezi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being diagnosed with Special Learning Disabilities
- To be between the ages of 7-15
- To attend the special education and rehabilitation center and individual support training program regularly.
- Not having exercise intolerance or any disease that prevents exercise
- The child's willingness to participate in the study and the consent of the parent to participate in the study
Exclusion Criteria:
- Having physical or psychological disorders in addition to the diagnosis of Special Learning Disabilities (ADHD, etc.)
- Being diagnosed with Special Learning Disabilities and not complying with the age range
- Not attending the individual training program regularly
- Parents not giving consent for the child to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: control group
continued their normal education and physiotherapy
|
The control group continued only the individual support education program.
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Experimental: experimental group
they continued their normal training and physiotherapy, in addition, purposeful balance and coordination exercises were given for 40 minutes a day, 2 days a week for 8 weeks.
|
In addition to the individual support training program, the exercise group was given a balance and coordination exercise protocol including 40 minutes, 2 days a week. These exercises are: It consisted of warm-up (10 minutes), purposeful balance and coordination exercises (20 minutes), and cool-down (10 minutes) exercises. Balance and coordination exercises with purpose were created with a series of exercises based on copying the shape of the blocks on the cards placed at the beginning of a track consisting of stations at the end of the track. The stations were composed of "hopscotch station", "tandem walking station in one line", "bounce station", "bucketing ping pong balls station" and "eight running stations". |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Quality of Life Scale for Children (QoL-C)
Time Frame: 10 weeks
|
Quality of Life Scale for Children, parent form for children or adolescents 2-4, 5-7, 8-12, 13-18 years old, and self for children or adolescents 5-7, 8-12, 13-18 years old It consists of a total of 7 forms, including a notification form.
This scale questions the last month of children and adolescents.
It was developed as a Likert-type scale with 3 options for children aged 5-7 and 5 options for children and adolescents aged 8-18.
Items are scored between 0-100.
The answer to the question is scored 100 if it is marked as never, 75 if it is marked as rarely, 50 if it is marked as sometimes, 25 if it is marked as often, and 0 if it is marked as almost always.
The total score is obtained by summing the scores and dividing by the number of items filled.
The score obtained is directly proportional to the quality of life.
|
10 weeks
|
Leisure Activity Questionnaire for Children (CPAQ)
Time Frame: 10 weeks
|
The form was filled by the children and their exercise levels were determined by calculations.
MET values were classified as low, medium, high and moderately high.
Low-intensity activities of 3 METs or less per hour are moderate and high-intensity activities of 3 METs and above.
It is considered as moderate (3-5.9
MET), high intensity (6 MET and above), and medium-high intensity (3 MET and above).
|
10 weeks
|
bourdon attention test
Time Frame: 10 weeks
|
Bourdon Test (also dubbed a/b/q Test, ABQ) is an approach to measure focus and attentiveness that requires its taker to spot and cross out the query chars a, b and q in a potpourri of letters. The test consists of two forms. The first is to find and mark certain letters among mixed book letters; the second one is in the form of finding and marking certain figures among the figures given as mixed. There are a total of 660 letters in the letter form of the test. In the letter form, certain letters are required to be found among the letters. There is no template created, and the practitioner can choose the letters or shapes he wants and ask the children to mark them, so that the practitioner can create his own template. |
10 weeks
|
bruninks oserertsky engine proficiency test-2(BOT-2)
Time Frame: 10 weeks
|
BOT-2 measures fine and gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation.
The test is tailored to school-aged children and young adults among the ages of 4-21 years, who have varying motor control abilities ranging from normal to mild or moderate.In both the BOT-2 short form (SF) this scale is used to transform the standard score to final categories (1 - well below average; 2 - below average; 3 - average; 4 - above average; 5 - well above average).The four motor-area composite standard scores, discussed below, range from 27 on Manual Coordination to 61 on Fine Manual Control.
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10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Elif PUNAR, Uskudar University
- Study Chair: Turgay ALTUNALAN, Karadeniz Technical University
Publications and helpful links
General Publications
- Maiano C, Hue O, Morin AJS, Lepage G, Tracey D, Moullec G. Exercise interventions to improve balance for young people with intellectual disabilities: a systematic review and meta-analysis. Dev Med Child Neurol. 2019 Apr;61(4):406-418. doi: 10.1111/dmcn.14023. Epub 2018 Sep 19.
- Blanchet M, Assaiante C. Specific Learning Disorder in Children and Adolescents, a Scoping Review on Motor Impairments and Their Potential Impacts. Children (Basel). 2022 Jun 15;9(6):892. doi: 10.3390/children9060892.
- Hallawell B, Stephens J, Charnock D. Physical activity and learning disability. Br J Nurs. 2012 May 24-Jun 13;21(10):609-12. doi: 10.12968/bjon.2012.21.10.609.
- Bluechardt MH, Wiener J, Shephard RJ. Exercise programmes in the treatment of children with learning disabilities. Sports Med. 1995 Jan;19(1):55-72. doi: 10.2165/00007256-199519010-00005.
- Fathi Azar E, Mirzaie H, Jamshidian E, Hojati E. Effectiveness of perceptual-motor exercises and physical activity on the cognitive, motor, and academic skills of children with learning disorders: A systematic review. Child Care Health Dev. 2023 Mar 5. doi: 10.1111/cch.13111. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uskudar71
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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