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临床试验/NCT05404126
NCT05404126Unknown不适用

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

University of Gaziantep1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Gait

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Gait

时间窗: 12 week

10 meters Walk Test

Dynamic Balance

时间窗: 12 week

Dynamic Balance Test; Four Step Square Test (DAKT)

Functional Mobility

时间窗: 12 week

Timed Up and Go Test

Fall

时间窗: 12 week

Fall History Survey

Fear of Falling

时间窗: 12 week

Tinetti; This is a 10 item test. Raging from 1 (not safe) to 10 (extremely safe). Maximum 100 Point.

Life Quality

时间窗: 12 week

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.

Static balance

时间窗: 12 week

Static balance test to evaluate balance; Flamingo Balance Test

Static balance-2

时间窗: 12 week

Static balance test to evaluate balance; Romberg

Dynamic Balance-2

时间窗: 12 week

Dynamic Balance Test; Functional Reach Test

Balance

时间窗: 12 week

Pediatric Berg Balance Scale; This is a 14 item test. Ranging from 0 (with help) to 4 (Normal), Maximum 56 Point.

Hand-Eye Coordination

时间窗: 12 week

9 Hole Peg Test

Functional Gait

时间窗: 12 week

Functional Gait Assessment; This is a 10 item test. from 0 (Severe) to 3 (Normal), Maximum 30 Point.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

HAFİZA GÖZEN

Lecturer

University of Gaziantep

研究点 (1)

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