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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03487757
Other study ID # bvudtuncer01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date January 1, 2020

Study information

Verified date March 2020
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 1, 2020
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 7 Years to 16 Years
Eligibility 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:

- 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

Study Design


Intervention

Other:
Core 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.
No 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.

Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory muscle strength Change from baseline maximum inspiratory pressure and maximum expiratory pressure at 8 weeks Eight weeks
Secondary Respiratory Functions-FVC Change from baseline Forced Vital Capacity (FVC) at 8 weeks Eight weeks
Secondary Respiratory Functions-FEV1 Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks Eight weeks
Secondary Respiratory Functions-PEF Change from baseline Peak Expiratory Flow (PEF) at 8 weeks Eight weeks
Secondary Postural control-postural stability Change from baseline postural stability test score in Biodex Balance System at 8 weeks Eight weeks
Secondary Postural control-limits of stability Change from baseline limits of stability test score in Biodex Balance System at 8 weeks Eight weeks
Secondary Postural control-sensory integration Change from baseline sensory integration and balance test core in Biodex Balance System at 8 weeks Eight weeks
Secondary Postural control-BESS Change from baseline Balance Error Scoring System (BESS) test scores at 8 weeks Eight weeks
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