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"Core Stabilization Exercises in Hearing Impaired Children"

Primary Purpose

Hearing Disorders in Children, Core Stabilization, Respiratory Muscle Strength

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Core Stabilization Exercises
No Intervention
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Disorders in Children

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakif University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Training Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Respiratory muscle strength
Change from baseline maximum inspiratory pressure and maximum expiratory pressure at 8 weeks

Secondary Outcome Measures

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

Full Information

First Posted
March 28, 2018
Last Updated
March 10, 2020
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT03487757
Brief Title
"Core Stabilization Exercises in Hearing Impaired Children"
Official Title
"The Effect of Core Stabilization Exercises on Respiratory Muscle Strength, Respiratory Functions and Postural Control in Hearing Impaired Children"
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Disorders in Children, Core Stabilization, Respiratory Muscle Strength, Respiratory Functions, Postural Control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Training Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Core Stabilization Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory muscle strength
Description
Change from baseline maximum inspiratory pressure and maximum expiratory pressure at 8 weeks
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Respiratory Functions-FVC
Description
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Time Frame
Eight weeks
Title
Respiratory Functions-FEV1
Description
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Time Frame
Eight weeks
Title
Respiratory Functions-PEF
Description
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Time Frame
Eight weeks
Title
Postural control-postural stability
Description
Change from baseline postural stability test score in Biodex Balance System at 8 weeks
Time Frame
Eight weeks
Title
Postural control-limits of stability
Description
Change from baseline limits of stability test score in Biodex Balance System at 8 weeks
Time Frame
Eight weeks
Title
Postural control-sensory integration
Description
Change from baseline sensory integration and balance test core in Biodex Balance System at 8 weeks
Time Frame
Eight weeks
Title
Postural control-BESS
Description
Change from baseline Balance Error Scoring System (BESS) test scores at 8 weeks
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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"Core Stabilization Exercises in Hearing Impaired Children"

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