Lack of; Attention, With Hyperactivity (ADHD)NCT05998083
The Effectiveness of Purposeful Exercises in Children Diagnosed With Special Learning Disabilities
A study testing exercise in people with Lack of; Attention, With Hyperactivity (ADHD) and Specific Learning Disability, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to examine the effect of purposeful balance and coordination exercises on attention and quality of life in children diagnosed with special learning disabilities. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Lack of; Attention, With Hyperactivity (ADHD), Specific Learning Disability
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 Apr 2022
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Purposeful Balance and Coordination Exercises on Attention and Quality of Life in Children Diagnosed With Special Learning Disabilities.
The aim of the study is to examine the effect of purposeful balance and coordination exercises on attention and quality of life in children diagnosed with special learning disabilities.
Read the detailed description
The study was planned as a randomized controlled trial, and children aged 7-17 who were diagnosed with "Special Learning Disability" in a special education center in Kocaeli-Darica were included as a sample. Children were divided into experimental and control groups by randomization. In addition to the individual training program they received from the special training center, the experimental group was given goal-oriented balance and coordination exercises for 8 weeks, 2 days a week for 40 minutes. The control group continued only the individual training program. All participants and their parents were informed about the study, and an informed consent form was obtained from the participants and their parents. In order to collect data from the participants; "Leisure Time Activity Questionnaire for Children" to determine physical activity levels, "Quality of Life Assessment Questionnaire for Children" to determine their quality of life, "Bruininks-Oseretsky Motor Proficiency Test 2 short form" to evaluate motor skills, "Burdon Attention Test" to measure attention level used. These tests and forms were repeated before starting the study and at the end of the study. Pre- and post-intervention data were statistically analyzed and compared.
- Being tested
- exercise, control
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
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".
controlOther
The control group continued only the individual support education program.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | continued their normal education and physiotherapy Receives: Other: control |
| experimental group | Experimental | 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. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quality of Life Scale for Children (QoL-C)
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.
Measured: 10 weeks
Leisure Activity Questionnaire for Children (CPAQ)
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).
Measured: 10 weeks
bourdon attention test
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.
Measured: 10 weeks
bruninks oserertsky engine proficiency test-2(BOT-2)
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Sep 2021
- Primary completion1 Nov 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lack of; Attention, With Hyperactivity (ADHD)Studies 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
- Parallel groups
- Model description
- In addition to the individual training program they received from the special training center, the experimental group was given goal-oriented balance and coordination exercises for 40 minutes, 2 days a week.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Elif PUNAR, Study chair, Uskudar UniversityTurgay ALTUNALAN, Study chair, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998083
- Sponsor's protocol ID
- Uskudar71
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35740829Hallawell 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.
PubMed 22875298Bluechardt 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.
PubMed 7740247Fathi 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 Nov;49(6):1006-1018. doi: 10.1111/cch.13111. Epub 2023 Mar 7.
PubMed 36872844Maiano 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.
PubMed 30230530Punar E, Sevgin O. Effect of goal-directed perceptual-motor exercise on children with specific learning difficulties: a randomized controlled trial. BMC Pediatr. 2024 Dec 19;24(1):820. doi: 10.1186/s12887-024-05309-6.
PubMed 39695424
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Purposeful Balance and Coordination Exercises on Attention and Quality of Life in Children Diagnosed With Special Learning Disabilities.
- ClinicalTrials.gov ID
- NCT05998083
- Acronym / sponsor ID
- Uskudar71
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 18 Aug 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 aim of the study is to examine the effect of purposeful balance and coordination exercises on attention and quality of life in children diagnosed with special learning disabilities.
Detailed description
The study was planned as a randomized controlled trial, and children aged 7-17 who were diagnosed with "Special Learning Disability" in a special education center in Kocaeli-Darica were included as a sample. Children were divided into experimental and control groups by randomization. In addition to the individual training program they received from the special training center, the experimental group was given goal-oriented balance and coordination exercises for 8 weeks, 2 days a week for 40 minutes. The control group continued only the individual training program. All participants and their parents were informed about the study, and an informed consent form was obtained from the participants and their parents. In order to collect data from the participants; "Leisure Time Activity Questionnaire for Children" to determine physical activity levels, "Quality of Life Assessment Questionnaire for Children" to determine their quality of life, "Bruininks-Oseretsky Motor Proficiency Test 2 short form" to evaluate motor skills, "Burdon Attention Test" to measure attention level used. These tests and forms were repeated before starting the study and at the end of the study. Pre- and post-intervention data were statistically analyzed and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In addition to the individual training program they received from the special training center, the experimental group was given goal-oriented balance and coordination exercises for 40 minutes, 2 days a week.
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: controlcontinued their normal education and physiotherapy |
| experimental group | Experimental | Other: exercisethey 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. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| exerciseIn 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". | Other | experimental group |
| controlThe control group continued only the individual support education program. | Other | control group |
Primary outcome
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.
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).
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.
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.
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 18 Aug 2023.
- Background: PubMed 35740829Blanchet 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.
- Background: PubMed 22875298Hallawell 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.
- Background: PubMed 7740247Bluechardt 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.
- Background: PubMed 36872844Fathi 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 Nov;49(6):1006-1018. doi: 10.1111/cch.13111. Epub 2023 Mar 7.
- Background: PubMed 30230530Maiano 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.
- Derived from this study: PubMed 39695424Punar E, Sevgin O. Effect of goal-directed perceptual-motor exercise on children with specific learning difficulties: a randomized controlled trial. BMC Pediatr. 2024 Dec 19;24(1):820. doi: 10.1186/s12887-024-05309-6.
- Individual participant dataSharing planned: No
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.
Elif PUNAR study chair
Uskudar University
Turgay ALTUNALAN study chair
Karadeniz Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Lack of; Attention, With Hyperactivity (ADHD) and Specific Learning Disability, run by Uskudar 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 5 inclusion and 4 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 18 Aug 2023. 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?
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?
The Quality of Life Scale for Children (QoL-C) (time frame: 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05998083, which also lists 6 linked publications.
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 18 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.