Clinical trial NCT05404126: Balance and Gait in Hearing Impaired Children
Official title: Nvestigation of the Effect of Dual-Task Focused Stroboscopic Visual Education on Balance and Gait in Hearing Impaired Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Balance
Gait
Keywords: balance
gait
deaf
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
Collaborators: name: Hasan Kalyoncu University
First posted: 2022-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Static balance
timeFrame: 12 week
measure: Static balance-2
timeFrame: 12 week
measure: Dynamic Balance
timeFrame: 12 week
measure: Dynamic Balance-2
timeFrame: 12 week
measure: Balance
timeFrame: 12 week
measure: Functional Mobility
timeFrame: 12 week
measure: Gait
timeFrame: 12 week
measure: Functional Gait
timeFrame: 12 week
measure: Fall
timeFrame: 12 week
measure: Fear of Falling
timeFrame: 12 week
measure: Hand-Eye Coordination
timeFrame: 12 week
measure: Life Quality
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University
Study officials:
affiliation: https://akbis.gantep.edu.tr/detay/?A_ID=187586_ogr-gor_hafiza-gozen
name: Hafiza Gözen
role: PRINCIPAL_INVESTIGATOR
affiliation: https://profil.hku.edu.tr/akademik/serkan-usgu/
name: Serkan Usgu
role: STUDY_DIRECTOR
References: