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Balance and Gait in Hearing Impaired Children (Balance)

Primary Purpose

Balance, Gait

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
Sponsored by
University of Gaziantep
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Balance focused on measuring balance, gait, deaf

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

In Hearing Impaired Groups

  • Between the ages of 7-12,
  • Not undergoing cochlear implant surgery,
  • Able to walk independently,
  • Having a hearing threshold of 71 decibels (dB) and above according to the hearing test,
  • Volunteers diagnosed with congenital bilateral sensorineural hearing impairment,

In the Healthy Group

  • Between the ages of 7-12,
  • Able to walk independently

Exclusion Criteria:

In Hearing Impaired Groups

  • In addition, having any physical or visual disability,
  • Lack of cooperation for the application,
  • Volunteers with a neurological or any orthopedic problem other than sensorinoral hearing loss that may affect their balance.

In the Healthy Group

  • Having any physical, visual or hearing impairment,
  • Lack of cooperation for the application.

Sites / Locations

  • Gaziantep University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

No Intervention

Arm Label

Control (Group 1)

Conventional Exercise Balance (Group 2)

Dual Task-Oriented Stroboscopic Visual Training Group (Group 3)

Healthy Control Group (Group 4)

Arm Description

Only assessments and scales will be applied to the participants in Group 1 at the beginning of the study and at the end of 12 weeks.

Group 2 will be included in the exercise program twice a week for 40 minutes for 12 weeks.

Group 3 will be included in the exercise program twice a week for 40 minutes for 12 weeks. Trainings are planned with one-on-one therapist.

Only assessments and scales will be applied to the participants in Group 4 at the beginning of the study and at the end of 12 weeks.

Outcomes

Primary Outcome Measures

Static balance
Static balance test to evaluate balance; Flamingo Balance Test
Static balance-2
Static balance test to evaluate balance; Romberg
Dynamic Balance
Dynamic Balance Test; Four Step Square Test (DAKT)
Dynamic Balance-2
Dynamic Balance Test; Functional Reach Test
Balance
Pediatric Berg Balance Scale; This is a 14 item test. Ranging from 0 (with help) to 4 (Normal), Maximum 56 Point.
Functional Mobility
Timed Up and Go Test
Gait
10 meters Walk Test
Functional Gait
Functional Gait Assessment; This is a 10 item test. from 0 (Severe) to 3 (Normal), Maximum 30 Point.
Fall
Fall History Survey
Fear of Falling
Tinetti; This is a 10 item test. Raging from 1 (not safe) to 10 (extremely safe). Maximum 100 Point.
Hand-Eye Coordination
9 Hole Peg Test
Life Quality
The Generic Children's Health Related Quality of Life Questionnare(Kid-KINDL); Kid-KINDL items are answered on a 5-point Likert-type scale, ranging from 1 (never) to 5 (always). Some items (1, 2, 3, 6, 7, 8, 15, 16, 20, and 24. items) with a negative orientation needed to be reverse coded, depending on the statement.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2022
Last Updated
May 30, 2022
Sponsor
University of Gaziantep
Collaborators
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT05404126
Brief Title
Balance and Gait in Hearing Impaired Children
Acronym
Balance
Official Title
Nvestigation of the Effect of Dual-Task Focused Stroboscopic Visual Education on Balance and Gait in Hearing Impaired Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Gaziantep
Collaborators
Hasan Kalyoncu University

4. Oversight

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

5. Study Description

Brief Summary
The investigators balance and balance related problems and exercise programs should be handled multi-dimensionally. In this study, the investigators' aim is to investigate the effect of dual task-oriented education with stroboscopic glasses on balance, functional mobility and general walking parameters in children with hearing impairment, despite conventional balance exercises. The study will be started when the consent form which prepared in accordance with the ethical committee conditions, explained and approved to all participants and their families. Participants aged 7-12 years, who have not undergone cochlear implant surgery, who can walk independently, have a hearing threshold of 75 decibels (dB) and above, and are diagnosed with congenital bilateral sensorineural hearing impairment will be included in the study. Hearing impaired children who have physical, visual impairment, lack of cooperation for the application and have any neurological problems (other than sensorineural hearing loss) or orthopedic problems that may affect their balance will not be included. Children who meet the inclusion criteria will be divided into three groups by block randomization method; as control (Group 1), conventional exercise balance (Group 2), dual task-oriented stroboscopic visual training group (Group 3) and a healthy control group (Group 4) without any disability will form the fourth group. Only assessments and scales will be applied to the participants in Group 1 and Group 4 at the beginning of the study and at the end of 12 weeks. Group 2 and Group 3 will be included in the exercise program twice a week for 40 minutes for 12 weeks. Conventional balance exercises are planned to be done in groups, and other trainings are planned with one-on-one therapist. Before starting exercise training, demographic characteristics such as dB values (specified in the health reports of), age (years), height (cm), body weight (kg) of the children included in the study will be recorded. At the beginning of the exercise training and at the end of the 12-week training; balance, functional mobility and gait, fall history and fear of falling, quality of life, hand-eye coordination will be evaluated. This study is important in terms of being an example for researches to be carried out for the hearing impaired or other disability groups and contributing to the exercise programs of the trainers working in this field.
Detailed Description
One of the important problem in individuals with congenital hearing impairment is the functional insufficiency of the balance centers that work in conjunction with each other because they cannot perceive auditorily external stimuli. Although the visual perceptions, proprioceptors and antigravity muscles work well,if vestibular system functions do not work well it adversely affect the the static and dynamic balance of standing. When the literature is examined, it is seen that there is limited research on the balance problems and exercises of the hearing impaired.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Balance, Gait
Keywords
balance, gait, deaf

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control (Group 1)
Arm Type
No Intervention
Arm Description
Only assessments and scales will be applied to the participants in Group 1 at the beginning of the study and at the end of 12 weeks.
Arm Title
Conventional Exercise Balance (Group 2)
Arm Type
Experimental
Arm Description
Group 2 will be included in the exercise program twice a week for 40 minutes for 12 weeks.
Arm Title
Dual Task-Oriented Stroboscopic Visual Training Group (Group 3)
Arm Type
Experimental
Arm Description
Group 3 will be included in the exercise program twice a week for 40 minutes for 12 weeks. Trainings are planned with one-on-one therapist.
Arm Title
Healthy Control Group (Group 4)
Arm Type
No Intervention
Arm Description
Only assessments and scales will be applied to the participants in Group 4 at the beginning of the study and at the end of 12 weeks.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
• Static exercises and dynamic exercises to group 2; Hearing impaired children in group 3 will be given motor-motor double-task and motor-cognitive double-task exercises in addition to conventional balance exercises.
Primary Outcome Measure Information:
Title
Static balance
Description
Static balance test to evaluate balance; Flamingo Balance Test
Time Frame
12 week
Title
Static balance-2
Description
Static balance test to evaluate balance; Romberg
Time Frame
12 week
Title
Dynamic Balance
Description
Dynamic Balance Test; Four Step Square Test (DAKT)
Time Frame
12 week
Title
Dynamic Balance-2
Description
Dynamic Balance Test; Functional Reach Test
Time Frame
12 week
Title
Balance
Description
Pediatric Berg Balance Scale; This is a 14 item test. Ranging from 0 (with help) to 4 (Normal), Maximum 56 Point.
Time Frame
12 week
Title
Functional Mobility
Description
Timed Up and Go Test
Time Frame
12 week
Title
Gait
Description
10 meters Walk Test
Time Frame
12 week
Title
Functional Gait
Description
Functional Gait Assessment; This is a 10 item test. from 0 (Severe) to 3 (Normal), Maximum 30 Point.
Time Frame
12 week
Title
Fall
Description
Fall History Survey
Time Frame
12 week
Title
Fear of Falling
Description
Tinetti; This is a 10 item test. Raging from 1 (not safe) to 10 (extremely safe). Maximum 100 Point.
Time Frame
12 week
Title
Hand-Eye Coordination
Description
9 Hole Peg Test
Time Frame
12 week
Title
Life Quality
Description
The Generic Children's Health Related Quality of Life Questionnare(Kid-KINDL); Kid-KINDL items are answered on a 5-point Likert-type scale, ranging from 1 (never) to 5 (always). Some items (1, 2, 3, 6, 7, 8, 15, 16, 20, and 24. items) with a negative orientation needed to be reverse coded, depending on the statement.
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: In Hearing Impaired Groups Between the ages of 7-12, Not undergoing cochlear implant surgery, Able to walk independently, Having a hearing threshold of 71 decibels (dB) and above according to the hearing test, Volunteers diagnosed with congenital bilateral sensorineural hearing impairment, In the Healthy Group Between the ages of 7-12, Able to walk independently Exclusion Criteria: In Hearing Impaired Groups In addition, having any physical or visual disability, Lack of cooperation for the application, Volunteers with a neurological or any orthopedic problem other than sensorinoral hearing loss that may affect their balance. In the Healthy Group Having any physical, visual or hearing impairment, Lack of cooperation for the application.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Gözen
Organizational Affiliation
https://akbis.gantep.edu.tr/detay/?A_ID=187586_ogr-gor_hafiza-gozen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Serkan Usgu
Organizational Affiliation
https://profil.hku.edu.tr/akademik/serkan-usgu/
Official's Role
Study Director
Facility Information:
Facility Name
Gaziantep University
City
Gaziantep
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Balance and Gait in Hearing Impaired Children

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