"Core Stabilization Exercises in Hearing Impaired Children"

"The Effect of Core Stabilization Exercises on Respiratory Muscle Strength, Respiratory Functions and Postural Control in Hearing Impaired 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.

Study Overview

• Status: Completed
• Conditions: Postural Control; Hearing Disorders in Children; Respiratory Muscle Strength; Respiratory Functions; Core Stabilization
• Intervention / Treatment: Other: No Intervention; Other: Core Stabilization Exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory muscle strength	Change from baseline maximum inspiratory pressure and maximum expiratory pressure at 8 weeks	Eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Functions-FVC	Change from baseline Forced Vital Capacity (FVC) at 8 weeks	Eight weeks
Respiratory Functions-FEV1	Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks	Eight weeks
Respiratory Functions-PEF	Change from baseline Peak Expiratory Flow (PEF) at 8 weeks	Eight weeks
Postural control-postural stability	Change from baseline postural stability test score in Biodex Balance System at 8 weeks	Eight weeks
Postural control-limits of stability	Change from baseline limits of stability test score in Biodex Balance System at 8 weeks	Eight weeks
Postural control-sensory integration	Change from baseline sensory integration and balance test core in Biodex Balance System at 8 weeks	Eight weeks
Postural control-BESS	Change from baseline Balance Error Scoring System (BESS) test scores at 8 weeks	Eight weeks

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 4, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Loss; Deafness; Hearing Disorders
• Other Study ID Numbers: bvudtuncer01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No