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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06354400
Other study ID # 2022/001-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 30, 2024
Est. completion date June 12, 2024

Study information

Verified date June 2024
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Children's motor skills and physical performance increase with age due to the development of neuromuscular and cardiorespiratory systems. Sensory impairment seen in children with hearing loss can cause balance and coordination disorders, as well as decreased muscle strength and respiratory functions. Anatomically, core stabilization is provided by the diaphragm, abdominal, hip, pelvic floor, and gluteal muscles. Training for these muscles is intended to improve strength, endurance, and neuromuscular control. This training can help to improve the control of intra-abdominal pressure, intersegmental control of the spine, and muscular control of trunk movement. It also helps in strengthening the respiratory muscles, especially the main inspiratory muscle, the diaphragm. In this study, the effects of core stabilization training on children with hearing impairments' thoracic mobility, functional ability, and trunk muscle endurance will be examined.


Description:

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Study Design


Intervention

Other:
Core stabilization training
Isometric exercises of the abdominal muscles in the supine, prone, and squatting positions; isotonic exercises in the supine, prone, squatting, and side-lying positions; isotonic exercises in coordination with the extremity movements in the supine, prone, and crawling positions; and trunk rotation exercises in the sitting position will be performed. The Swiss ball will be used for dynamic exercises. It will include isometric and isotonic exercises of the abdominal muscles. Exercises will start with 3 sets of 20 repetitions, gradually increase in intensity on static and dynamic surfaces, and progress towards difficulty. Each exercise will be performed in coordination with breathing control. Breathing control will be coordinated with every exercise.

Locations

Country Name City State
Turkey Nuh Naci Yazgan University Kayseri

Sponsors (2)

Lead Sponsor Collaborator
Bezmialem Vakif University Nuh Naci Yazgan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chest expansion Chest wall expansion will be measured with a standard measuring tape at three different levels. While the child is in an upright position, with his feet shoulder-width apart and his arms relaxed at his side, measurements will be taken from three areas: at the axilla level (upper level), at the xiphoid level (middle level) and at the subcostal level (lower level).
The physical therapist standing in front of the child will initially ask the child to breathe normally to determine the tidal volume, after placing the tape measure around the chest. The child will be asked to exhale maximally and then inhale maximally. The difference between the two scales (inhalation - exhalation) will be determined as thoracic expansion (chest expansion). Participants will be instructed to perform three maneuvers and the obtained values will be averaged and recorded. Data will be measured by the same physiotherapist to minimize possible errors due to heterogeneity.
Baseline and immediately after the training
Secondary Functional capacity The 6-minute walk test (6MWT) is a commonly used submaximal exercise test to assess functional capacity. This test, used to measure cardiovascular endurance, is a clinical indicator of functional capacity and helps measure the ability to perform activities of daily living. The 6MWT will be performed in accordance with The American Thoracic Society guidelines. The participant will be instructed to walk as fast as possible on a 30 m path for 6 minutes, but not to run. The child will sit in a chair close to the starting position and vital values (heart rate and respiratory rate) will be recorded before administering the test. At the end of the test, the distance walked for 6 minutes will be recorded as 6 minutes walking distance (6MWD). After completion of the test, heart rate, respiratory rate will be measured and the child will be asked about the maximum fatigue level after completing the test using the Borg scale. Baseline and immediately after the training
Secondary Trunk muscle endurance Curl-up: Measures the muscle endurance of the abdominal muscles. The test begins in a supine position, with the lower extremities abducted at approximately shoulder width and the knees semiflexed. Static back endurance test: Measures the endurance of the back muscles. The test begins in a prone position, with the inguinal area at the end of the table and the pelvis, hips and knees extended flat on the table. Horizontal side bridging: Measures the endurance of the spinal stabilizer muscles. The test begins in a side-lying position with the lower extremities extended and the upper foot placed in front of the lower foot for support. Baseline and immediately after the training
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