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The Effect of an 8-Week Combined Tele-Exercises on Balance, Forward Head, Proprioception and Neck Muscle Endurance of Students With Visual Impairement

Protocol summary

Study aim
The Effect of an 8 Week Combined Tele Exercises on Balance, Forward Head, Proprioception and Neck Muscle Endurance of Students with Visual Impairement
Design
The clinical trial has 30 participants in two groups of 15 experimental and control, without blinding, randomly classified.
Settings and conduct
After carefully evaluating the criteria for entering the research, the dependent variables will be evaluated with standard tests and the results will be recorded. At the end of the course, the variables are tested again and the secondary and primary results are compared to evaluate the effectiveness of the exercises.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Presence of: Legal or educational low vision, Students 7 to 18 years old, Craniovertebral angle less than 50 degrees, Interest and written consent; Absence of: Acute height disorders, Hearing and nervous system defects, Fractures and severe pain in neck, Exercise programs, Occupational therapy or regular corrective exercises, Mental illness, Other disabilities; Non-inclusion criteria: Non-adherence to exercise program, Acute heart and respiratory problems, History of sensitive eye surgeries
Intervention groups
The experimental group will receive and perform Ultimate Fit (UF) training for 8 weeks via cyberspace (mobile). The control group will not receive training during the same period.
Main outcome variables
Balance, Forward head, Proprioception and Endurance of neck muscles

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210723051960N1
Registration date: 2021-08-18, 1400/05/27
Registration timing: prospective

Last update: 2021-08-18, 1400/05/27
Update count: 0
Registration date
2021-08-18, 1400/05/27
Registrant information
Name
Zahra Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 6701
Email address
zahra.ebrahimi.h@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-21, 1400/05/30
Expected recruitment end date
2021-10-21, 1400/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of an 8-Week Combined Tele-Exercises on Balance, Forward Head, Proprioception and Neck Muscle Endurance of Students With Visual Impairement
Public title
The Effect of Corrective Exercises on Balance, Head Alignment, Sense of Position and Neck Endurance of Visually Impaired Students
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Craniovertebral angle less than 50 degrees Interest and written consent of parents and students Educational (use of large-print book) or legal visual impairment (visual acuity between 20/70 and 20/200 in the better eye after vision correction) 7-18 years old students
Exclusion criteria:
Acute erectile deformity and apparent differences in limb length Nervous system and auditory system defects Fractures, surgery or joint diseases of the spine Dizziness, headache and severe pain in the neck or upper limbs A history of regular exercise, occupational therapy, or correctional exercises in the past year Mental diseases Other disabilities
Age
From 7 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the Restricted randomization method for all study groups with equal sample size, and among the various restricted randomization methods, we will use Stratified randomization before random allocation, so that both groups in terms of severity of visual impairment and age become homogeneous as far as possible. First, students with more severe visual impairments will be grouped according to the age (or educational level) component. Thus, we consider a number for each person. We throw the balls (sheets) into a container and then randomly remove the balls (sheets) from the container without replacement. We record the generated sequence and place it in two groups of control and experimental. Then we will divide the rest of the participants who have milder visual impairment according to their age (or educational level) in the same way (using balls (sheets) without replacement), and will place them in two groups of control and experimental. Concealment will not be performed as it is not possible to disclose random sequencing and be aware of subsequent allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Isfahan Branch (Khorasgan)
Street address
University Blvd, Arghavanieh, East Jay St
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Approval date
2021-07-07, 1400/04/16
Ethics committee reference number
IR.IAU.KHUISF.REC.1400.086

Health conditions studied

1

Description of health condition studied
Balance
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Forward head
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Neck proprioception
ICD-10 code
ICD-10 code description

4

Description of health condition studied
Neck muscle endurance
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Static balance
Timepoint
Before the start of the interventions and a few days after the end of the training interventions
Method of measurement
Using a single-legged standing test with open eyes

2

Description
Dynamic balance
Timepoint
Before the start of the interventions and a few days after the end of the training interventions
Method of measurement
Using the modified star excursion balance test

3

Description
Forward head
Timepoint
Before the start of the interventions and a few days after the end of the training interventions
Method of measurement
Using a photo of the lateral view of people and measuring the cranio-cervical angle by Kinovea software

4

Description
Repositioning error
Timepoint
Before the start of the interventions and a few days after the end of the training interventions
Method of measurement
Using laser marker and calibrated screen

5

Description
Endurance of the deep flexor muscles of the neck
Timepoint
Before the start of the interventions and a few days after the end of the training interventions
Method of measurement
Using the deep neck flexor endurance test

6

Description
Endurance of deep neck extensor muscles of the neck
Timepoint
Before the start of the interventions and a few days after the end of the training interventions
Method of measurement
Using deep neck extensor endurance test

Secondary outcomes

1

Description
Musculoskeletal discomfort
Timepoint
Before the start of the interventions and a few days after the end of the training interventions
Method of measurement
Cornell Musculoskeletal Discomfort Questionnaire (CMDQ)

Intervention groups

1

Description
Intervention group: This group will perform UF exercises for 2 months, 3 days a week and each session for 60 to 70 minutes. Each session consists of 3 parts of a 5-part exercise. At the beginning of the exercise program, a general warm-up is performed for 10 minutes and then a specific warm-up of the neck area for 30 seconds. After that, the training sections are performed three times: 1-Static balance exercises are combined with proprioception exercises and are performed for 2 minutes. 2-Cardiovascular endurance exercises are combined with dynamic balance exercises and are held for 30 seconds, then 1 minute of rest is included. 3-Exercises for muscle endurance in the neck area (flexors and extensors) are combined with exercises for correcting the angle of the head and held for 30 seconds. After the end of each part and 1 to 2 minutes of rest, the next parts are done in the same way. After completing the three parts, the parts are repeated from the beginning, and after each part is repeated 3 times, the neck flexibility exercises are performed for 30 seconds and 3 repetitions. At the end of 5 minutes the general cooling is done.
Category
Rehabilitation

2

Description
Control group: This group will not receive any training during the time the experimental group is doing the exercises.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Primary and secondary schools of Isfahan province
Full name of responsible person
Zahra Ebrahimi
Street address
Floor2, Right Side No. 3, Bahar Alley, 23(Khordad) Alley, Ghaemieh St
City
Isfahan
Province
Isfehan
Postal code
8177955795
Phone
+98 31 3776 6701
Email
zahra.ebrahimi7379@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Majid Toghyani
Street address
University Blvd, Arghavanieh, East Jay St.
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4001
Fax
+98 31 3535 4060
Email
info@khuisf.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Ebrahimi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Sport Pathology and Corrective Exercises, Corrective Exercises
Street address
Floor2, Right Side No. 3, Bahar Alley, 23(Khordad) Alley, Ghaemieh St
City
Isfahan
Province
Isfehan
Postal code
8177955795
Phone
+98 31 3776 6701
Email
zahra.ebrahimi7379@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Technology, Physical education center
Full name of responsible person
Dr. Mojtaba Babaei khorzoghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Pathology and Corrective Exercises; Sport Therapy
Street address
Physical education center, Isfahan University of Technology
City
Isfahan
Province
Isfehan
Postal code
8415683111
Phone
+98 31 3391 2940
Email
babaei@iut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Ebrahimi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Sport Pathology and Corrective Exercises, Corrective Exercises
Street address
Floor2, Right Side No. 3, Bahar Alley, 23(Khordad) Alley, Ghaemieh St
City
Isfahan
Province
Isfehan
Postal code
8177955795
Phone
0098 31 7766701
Email
zahra.ebrahimi7379@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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