NCT06354400

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

March 30, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

March 29, 2024

Last Update Submit

June 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Functional capacity

    Baseline and immediately after the training

  • Trunk muscle endurance

    Baseline and immediately after the training

Study Arms (2)

Study group

EXPERIMENTAL

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.

Other: Core stabilization training

Control group

NO INTERVENTION

Since no training will be given to the control group during the study, we consider it ethically necessary to provide the same training to the control group if it proves effective after the study is over.

Interventions

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.

Study group

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Presence of clinically diagnosed prelingual sensorineural hearing loss
  • Absence of any neurological or orthopedic problems
  • Absence of any mental disorder, developmental disorder or syndrome
  • Not having participated in any core (trunk) stabilization exercises during the previous six months
  • Not having used any medication that would affect respiratory functions in the last 3 months

You may not qualify if:

  • Intellectual disability that would prevent participation in evaluation and treatment
  • Presence of chronic respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuh Naci Yazgan University

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Deniz Tuncer, PhD, PT

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 29, 2024

First Posted

April 9, 2024

Study Start

March 30, 2024

Primary Completion

June 12, 2024

Study Completion

June 12, 2024

Last Updated

June 14, 2024

Record last verified: 2024-06

Locations