Balance and Gait in Hearing Impaired Children

Balance Clinical Trial

— Balance  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05404126
• Other study ID #: hgözen
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: May 2022
• Source: University of Gaziantep
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: January 30, 2023
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Balance
• Deafness
• Gait
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
Turkey	Gaziantep University	Gaziantep

Sponsors (2)

Lead Sponsor	Collaborator
University of Gaziantep	Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

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