Developmental DisabilityNCT06353867
The Effect of Group Exercise in Children With Special Needs
A study testing Group Exercise in people with Developmental Disability and Child Autism, run by Istanbul Gedik University at 1 site in Turkey (Türkiye).
Trial summary
Thirty children with special needs were included in the study. Participants engaged in group exercises twice a week for four weeks, including warm-up and cool-down periods, with the goal of improving balance. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Developmental Disability, Child Autism
- What is being tested?
- Group Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Dec 2022to 25 Apr 2023
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-15 years with special needs
- Able to walk independently
Who cannot join
- Children with visual problems,
- Any orthopaedic, rheumatic or neurological problems affecting balance,
- Any contraindication to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Group Exercise on Balance and Attention Level in Children With Special Needs
Thirty children with special needs were included in the study. Participants engaged in group exercises twice a week for four weeks, including warm-up and cool-down periods, with the goal of improving balance. The participants' balance was assessed using the Bruininks-Oseretsky Motor Proficiency Test Short Form (Balance Parameters), Pediatric Balance Scale; functional mobility was evaluated using the Timed Up and Go Test, and attention level was assessed using the Stroop Test before and after the intervention.
- Conditions
- Developmental Disability, Child Autism
- Being tested
- Group Exercise
- Keywords
- developmental disability, balance, attention, group exercise
- Medical subject headings
- Developmental Disabilities, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ExerciseOther
The children with special needs included in the study were included in group exercises for 45 minutes 2 days a week in groups of 10 children each. Group exercises were planned as balance and coordination exercises including warm-up and cool-down periods. In the warm-up and cool-down periods, counting in place and balance exercises were performed. The exercises included tasks such as side walking, tandem walking, walking on a balance board, walking in a figure 8, walking over obstacles, throwing a ball to the person next to him/her while passing through cones, and throwing a ball by jumping while passing through cones.The exercises were made more difficult by following a progressive method every 2 weeks. The exercises were performed in 3 sets of 5 repetitions under the supervision of a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Group Exercise | Experimental | Not described Receives: Other: Group Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruininks-Oseretsky Motor Competence Test Short Form Balance Subtest (Balance Subtest of BOT 2-KF)
- Standing on the dominant leg on the balance board: The participant will be asked to stand on the balance board with his/her eyes open on his/her dominant foot, looking at the target, with his/her hands on his/her waist and the other leg parallel to the ground for 10 seconds. Scoring will be recorded as 0-0.9 s 0 points, 1-2.9 s 1 point, 3-5.9 s 2 points, 6-9.9 s 3 points and 10 s 4 points according to the duration of standing on one leg.
- Tandem (heel-thumb) walking on the walking line: The participant will be asked to place his/her hands on his/her waist and walk along the walking line. When 6 steps are completed, the test is stopped. Steps that does not go beyond the line are evaluated. Scoring is done as 0 step 0 points, 1-2 steps 1 point, 3-4 steps 2 points, 5 steps 3 points and 6 steps 4 points.
Measured: Baseline and after the interventions (4th week)
Paediatric Balance Scale
The version consisting of 14 sections and each section scored between 0-4 is used to evaluate the balance status of the participants.
Measured: Baseline and after the interventions (4th week)
Functional Reach Test
The participant is asked to reach as far as he/she can horizontally at the level of a tape measure fixed to the wall with arms at 90 flexion. The test is repeated 3 times and the measurements are averaged.
Measured: Baseline and after the interventions (4th week)
Timed Up and Go Test
It will be applied to assess balance and functional ambulation. The participant is asked to get up from a chair, walk 3 metres, turn around and sit down again. The time it took to complete the test will be recorded.
Measured: Baseline and after the interventions (4th week)
Stroop Test
The Stroop Test is among the neuropsychological tests frequently used to assess attention level and executive functions in children. Participants' time to complete the test is recorded.
Measured: Baseline and after the interventions (4th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start27 Dec 2022
- Primary completion15 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilityStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gedik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokce Kartal, Istanbul Gedik University
- Investigators
- Gokce Kartal, PT, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353867
- Sponsor's protocol ID
- 56365223-050.01.04-2023.13754
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 9 Apr 2024
- Results posted
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Group Exercise on Balance and Attention Level in Children With Special Needs
- ClinicalTrials.gov ID
- NCT06353867
- Acronym / sponsor ID
- 56365223-050.01.04-2023.13754
- Conditions
- Developmental Disability, Child Autism
- Keywords
- developmental disability, balance, attention, group exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Gedik UniversityUniversity, hospital or other
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 9 Apr 2024 (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.
Thirty children with special needs were included in the study. Participants engaged in group exercises twice a week for four weeks, including warm-up and cool-down periods, with the goal of improving balance. The participants' balance was assessed using the Bruininks-Oseretsky Motor Proficiency Test Short Form (Balance Parameters), Pediatric Balance Scale; functional mobility was evaluated using the Timed Up and Go Test, and attention level was assessed using the Stroop Test before and after the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Exercise | Experimental | Other: Group Exercise |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 6-15 years with special needs
- Able to walk independently
Key exclusion criteria (3 listed)
- Children with visual problems,
- Any orthopaedic, rheumatic or neurological problems affecting balance,
- Any contraindication to exercise
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 |
|---|---|---|
| Group ExerciseThe children with special needs included in the study were included in group exercises for 45 minutes 2 days a week in groups of 10 children each. Group exercises were planned as balance and coordination exercises including warm-up and cool-down periods. In the warm-up and cool-down periods, counting in place and balance exercises were performed. The exercises included tasks such as side walking, tandem walking, walking on a balance board, walking in a figure 8, walking over obstacles, throwing a ball to the person next to him/her while passing through cones, and throwing a ball by jumping while passing through cones.The exercises were made more difficult by following a progressive method every 2 weeks. The exercises were performed in 3 sets of 5 repetitions under the supervision of a physiotherapist. | Other | Group Exercise |
Primary outcome
Bruininks-Oseretsky Motor Competence Test Short Form Balance Subtest (Balance Subtest of BOT 2-KF)
Time frame: Baseline and after the interventions (4th week)
1. Standing on the dominant leg on the balance board: The participant will be asked to stand on the balance board with his/her eyes open on his/her dominant foot, looking at the target, with his/her hands on his/her waist and the other leg parallel to the ground for 10 seconds. Scoring will be recorded as 0-0.9 s 0 points, 1-2.9 s 1 point, 3-5.9 s 2 points, 6-9.9 s 3 points and 10 s 4 points according to the duration of standing on one leg. 2. Tandem (heel-thumb) walking on the walking line: The participant will be asked to place his/her hands on his/her waist and walk along the walking line. When 6 steps are completed, the test is stopped. Steps that does not go beyond the line are evaluated. Scoring is done as 0 step 0 points, 1-2 steps 1 point, 3-4 steps 2 points, 5 steps 3 points and 6 steps 4 points.
Paediatric Balance Scale
Time frame: Baseline and after the interventions (4th week)
The version consisting of 14 sections and each section scored between 0-4 is used to evaluate the balance status of the participants.
Functional Reach Test
Time frame: Baseline and after the interventions (4th week)
The participant is asked to reach as far as he/she can horizontally at the level of a tape measure fixed to the wall with arms at 90 flexion. The test is repeated 3 times and the measurements are averaged.
Timed Up and Go Test
Time frame: Baseline and after the interventions (4th week)
It will be applied to assess balance and functional ambulation. The participant is asked to get up from a chair, walk 3 metres, turn around and sit down again. The time it took to complete the test will be recorded.
Stroop Test
Time frame: Baseline and after the interventions (4th week)
The Stroop Test is among the neuropsychological tests frequently used to assess attention level and executive functions in children. Participants' time to complete the test is recorded.
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 9 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Developmental Disability
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
Gokce Kartal, PT principal investigator
Marmara 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 Group Exercise in people with Developmental Disability and Child Autism, run by Istanbul Gedik 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 2 inclusion and 3 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 9 Apr 2024. 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?
Bruininks-Oseretsky Motor Competence Test Short Form Balance Subtest (Balance Subtest of BOT 2-KF) (time frame: Baseline and after the interventions (4th week)). The study lists 5 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 9 Apr 2024.