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

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ClinicalTrials.gov Identifier: NCT03487757
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Deniz Tuncer, Bezmialem Vakif University

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.

Condition or disease Intervention/treatment Phase
Hearing Disorders in Children Core Stabilization Respiratory Muscle Strength Respiratory Functions Postural Control Other: Core Stabilization Exercises Other: No Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "The Effect of Core Stabilization Exercises on Respiratory Muscle Strength, Respiratory Functions and Postural Control in Hearing Impaired Children"
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Respiratory muscle strength [ Time Frame: Eight weeks ]
    Change from baseline maximum inspiratory pressure and maximum expiratory pressure at 8 weeks


Secondary Outcome Measures :
  1. Respiratory Functions [ Time Frame: Eight weeks ]
    Change from baseline Forced Vital Capacity (FVC) at 8 weeks

  2. Respiratory Functions [ Time Frame: Eight weeks ]
    Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks

  3. Respiratory Functions [ Time Frame: Eight weeks ]
    Change from baseline Peak Expiratory Flow (PEF) at 8 weeks

  4. Postural control [ Time Frame: Eight weeks ]
    Change from baseline postural stability test score in Biodex Balance System at 8 weeks

  5. Postural control [ Time Frame: Eight weeks ]
    Change from baseline limits of stability test score in Biodex Balance System at 8 weeks

  6. Postural control [ Time Frame: Eight weeks ]
    Change from baseline sensory integration and balance test core in Biodex Balance System at 8 weeks

  7. Postural control [ Time Frame: Eight weeks ]
    Change from baseline Balance Error Scoring System (BESS) test scores at 8 weeks



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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487757


Contacts
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Contact: Deniz Tuncer, PT, MSc +902125232288 ext 4648 tuncerdeniz82@gmail.com

Locations
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Turkey
Bezmialem Vakif University Recruiting
Istanbul, Turkey
Contact: Deniz Tuncer, PT, MSc    +902125232288 ext 4650    dtuncer@bezmialem.edu.tr   
Sponsors and Collaborators
Bezmialem Vakif University

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Responsible Party: Deniz Tuncer, Lecturer, PT, MSc, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03487757     History of Changes
Other Study ID Numbers: bvudtuncer01
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

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

Additional relevant MeSH terms:
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Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms