Balance and Gait in Hearing Impaired Children (Balance)

Nvestigation of the Effect of Dual-Task Focused Stroboscopic Visual Education on Balance and Gait in Hearing Impaired Children

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gait; Balance
• Intervention / Treatment: Other: exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gaziantep, Turkey
    • Gaziantep University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control (Group 1); 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.
Experimental: Conventional Exercise Balance (Group 2); Group 2 will be included in the exercise program twice a week for 40 minutes for 12 weeks.	Other: exercise; • 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.
Experimental: Dual Task-Oriented Stroboscopic Visual Training Group (Group 3); 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.	Other: exercise; • 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.
No Intervention: Healthy Control Group (Group 4); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static balance	Static balance test to evaluate balance; Flamingo Balance Test	12 week
Static balance-2	Static balance test to evaluate balance; Romberg	12 week
Dynamic Balance	Dynamic Balance Test; Four Step Square Test (DAKT)	12 week
Dynamic Balance-2	Dynamic Balance Test; Functional Reach Test	12 week
Balance	Pediatric Berg Balance Scale; This is a 14 item test. Ranging from 0 (with help) to 4 (Normal), Maximum 56 Point.	12 week
Functional Mobility	Timed Up and Go Test	12 week
Gait	10 meters Walk Test	12 week
Functional Gait	Functional Gait Assessment; This is a 10 item test. from 0 (Severe) to 3 (Normal), Maximum 30 Point.	12 week
Fall	Fall History Survey	12 week
Fear of Falling	Tinetti; This is a 10 item test. Raging from 1 (not safe) to 10 (extremely safe). Maximum 100 Point.	12 week
Hand-Eye Coordination	9 Hole Peg Test	12 week
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.	12 week

Collaborators and Investigators

• Sponsor: University of Gaziantep
• Collaborators: Hasan Kalyoncu University
• Investigators: Principal Investigator: Hafiza Gözen, https://akbis.gantep.edu.tr/detay/?A_ID=187586_ogr-gor_hafiza-gozen; Study Director: Serkan Usgu, https://profil.hku.edu.tr/akademik/serkan-usgu/

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): January 30, 2023

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: gait; balance; deaf
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: hgözen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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