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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06353867
Other study ID # 56365223-050.01.04-2023.13754
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 27, 2022
Est. completion date April 25, 2023

Study information

Verified date April 2024
Source Istanbul Gedik University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 25, 2023
Est. primary completion date April 15, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 15 Years
Eligibility 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 Design


Intervention

Other:
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.

Locations

Country Name City State
Turkey Marmara University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Gedik University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Baseline and after the interventions (4th week)
Primary 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. Baseline and after the interventions (4th week)
Primary 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. Baseline and after the interventions (4th week)
Primary 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. Baseline and after the interventions (4th week)
Primary 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. Baseline and after the interventions (4th week)
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