NCT03487757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

March 28, 2018

Last Update Submit

March 10, 2020

Conditions

Hearing Disorders in ChildrenCore StabilizationRespiratory Muscle StrengthRespiratory FunctionsPostural Control

Outcome Measures

Primary Outcomes (1)

  • Respiratory muscle strength

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

    Eight weeks

Secondary Outcomes (7)

  • Respiratory Functions-FVC

    Eight weeks

  • Respiratory Functions-FEV1

    Eight weeks

  • Respiratory Functions-PEF

    Eight weeks

  • Postural control-postural stability

    Eight weeks

  • Postural control-limits of stability

    Eight weeks

  • +2 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Training Group

EXPERIMENTAL

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

Core Stabilization ExercisesOTHER

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.

Training Group
No InterventionOTHER

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.

Control Group

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Tuncer D, Gurses HN. The Effects of Core Stabilization Exercises on Respiratory Muscle Strength, Respiratory Functions, and Postural Control in Children With Hearing Loss: A Randomized Controlled Trial. Ear Hear. 2024 Mar-Apr 01;45(2):306-315. doi: 10.1097/AUD.0000000000001428. Epub 2023 Oct 3.

    PMID: 37784232DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, PT, MSc

Study Record Dates

First Submitted

March 28, 2018

First Posted

April 4, 2018

Study Start

July 1, 2018

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

March 11, 2020

Record last verified: 2020-03

Locations

TU(1)