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CompletedNCT03487757Updated Mar 11, 2020

"Core Stabilization Exercises in Hearing Impaired Children"

An interventional study of Core Stabilization Exercises and No Intervention in Hearing Disorders in Children, Core Stabilization and Respiratory Muscle Strength, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 7 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-03-11.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
7 Years to 16 Years
Sex
All
01

Study summary

In this study the investigators will examine the effects of core stabilization exercises on respiratory muscle strength, respiratory functions and postural control in hearing-impaired children.

Read the detailed description

Hearing organs develop together with the vestibular system and work with close cooperation. Because of this close neuro-anatomic relationship; cochlear, semicircular canal, or both may cause damage to the vestibular dysfunction, resulting in imbalance. Sensory impairment in children with hearing loss may lead to decreased muscle strength and respiratory function with balance and coordination disorders. Core stabilization is provided anatomically with abdominal muscles at the front, spinal and gluteal muscles at the back, diaphragm at the top and pelvic floor and hip muscles at the bottom. Core stabilization training is a training to increase the strength, endurance and neuromuscular control of the aforementioned muscles.

When the literature is checked, the invetigators find that postural control is being evaluated in children with hearing impairment, but there are few studies evaluating respiratory functions. However, they did not encounter a study in which respiratory muscle strength was assessed in these children. In this study the investigators will examine the effects of core stabilization exercises on respiratory muscle strength, respiratory functions and postural control in hearing-impaired children.

02

Conditions studied

  • Hearing Disorders in Children
  • Core Stabilization
  • Respiratory Muscle Strength
  • Respiratory Functions
  • Postural Control

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03

In context

Hearing Disorders

65 studies on the registry are indexed under Hearing Disorders; 17 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 45 interventional studies indexed under Hearing Disorders.

Browse Hearing Disorders studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 354 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Between the ages of 7-16
  • Clinically diagnosed sensorineural hearing loss
  • Prelingual hearing loss
  • No neurological and orthopedic problems
  • Absence of syndrome or disease that may lead to mental disorder, impaired development and impaired vision
  • Not participating in any core stabilization, strengthening and balance program in the past six months
  • No medication to affect respiratory functions in the past 3 months
  • Parental permission for participation of child in the study

Exclusion criteria

Exclusion Criteria:

  • Intellectual disability for participating to the evaluation and training program
  • Presence of chronic respiratory disease
  • Not to join the training for more than 3 days
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Control Group

    After recording the demographic and clinical information at the beginning of the study and after 8 weeks, respiratory muscle strength, respiratory functions and postural control evaluations will be performed to the children. They won't receive any intervention by this time. At the end of 8 weeks, they may be included in the 8-week physiotherapy program, which will be once a week and 45-60 minutes by supervision of physiotherapist and 4 days a week home exercise program. The program will include core stabilization exercise training.

    Other: No Intervention

  • Experimental
    Training Group

    After recording the demographic and clinical information at the beginning of the study, respiratory muscle strength, respiratory functions and postural control evaluations will be performed to the children. They will be included in the 8-week physiotherapy program, which will be once a week and 45-60 minutes by supervision of physiotherapist and 4 days a week home exercise program. The program will include core stabilization exercise training. After the eight week training program the evaluations will be repeated.

    Other: Core Stabilization Exercises

Interventions

  • OtherCore Stabilization Exercises

    Jeffrey's core stabilization exercise training protocol will be performed to the training group. This protocol includes exercises progressing gradually from level 1 to level 3. Level 1; static contraction training on a stable surface, level 2; dynamic training on a stable surface, level 3; dynamic and resistant training on an unstable surface.

  • OtherNo Intervention

    Since no training is given to the control group during the study period, it is ethically necessary to give the same training to the control group if the benefit is achieved when the study is completed.

06

What researchers measure

Primary outcomes

  1. Respiratory muscle strength

    Change from baseline maximum inspiratory pressure and maximum expiratory pressure at 8 weeks

    Time frame: Eight weeks

Secondary outcomes

  1. Respiratory Functions-FVC

    Change from baseline Forced Vital Capacity (FVC) at 8 weeks

    Time frame: Eight weeks

  2. Respiratory Functions-FEV1

    Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks

    Time frame: Eight weeks

  3. Respiratory Functions-PEF

    Change from baseline Peak Expiratory Flow (PEF) at 8 weeks

    Time frame: Eight weeks

  4. Postural control-postural stability

    Change from baseline postural stability test score in Biodex Balance System at 8 weeks

    Time frame: Eight weeks

  5. Postural control-limits of stability

    Change from baseline limits of stability test score in Biodex Balance System at 8 weeks

    Time frame: Eight weeks

  6. Postural control-sensory integration

    Change from baseline sensory integration and balance test core in Biodex Balance System at 8 weeks

    Time frame: Eight weeks

  7. Postural control-BESS

    Change from baseline Balance Error Scoring System (BESS) test scores at 8 weeks

    Time frame: Eight weeks

07

Study locations

1 site
  • Bezmialem Vakif University
    Istanbul, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03487757
Responsible party
Deniz Tuncer (Lecturer, PT, MSc, Bezmialem Vakif University) — Principal investigator
First posted
Apr 4, 2018
Start date
Jul 1, 2018
Primary completion
Dec 1, 2019
Completion
Jan 1, 2020
Last update
Mar 11, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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