- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06353867
The Effect of Group Exercise in Children With Special Needs
April 3, 2024 updated by: Gokce Kartal, Istanbul Gedik University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Marmara University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Children aged 6-15 years with special needs
- Able to walk independently
Exclusion Criteria:
- Children with visual problems,
- Any orthopaedic, rheumatic or neurological problems affecting balance,
- Any contraindication to exercise
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group Exercise
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bruininks-Oseretsky Motor Competence Test Short Form Balance Subtest (Balance Subtest of BOT 2-KF)
Time Frame: Baseline and after the interventions (4th week)
|
|
Baseline and after the interventions (4th week)
|
|
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.
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Baseline and after the interventions (4th week)
|
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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.
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Baseline and after the interventions (4th week)
|
|
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.
|
Baseline and after the interventions (4th week)
|
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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.
|
Baseline and after the interventions (4th week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gokce Kartal, PT, Marmara University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 27, 2022
Primary Completion (Actual)
April 15, 2023
Study Completion (Actual)
April 25, 2023
Study Registration Dates
First Submitted
April 3, 2024
First Submitted That Met QC Criteria
April 3, 2024
First Posted (Actual)
April 9, 2024
Study Record Updates
Last Update Posted (Actual)
April 9, 2024
Last Update Submitted That Met QC Criteria
April 3, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 56365223-050.01.04-2023.13754
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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