The effect of 8 weeks corrective exercises on Forward Head abnormality
in blind and low vision women
Design
The clinical trial with a control group, eight weeks of corrective and untrained exercises, with parallel and randomized groups including 40 blind and low vision women
Settings and conduct
In this study, 40 blind and low vision women with Forward Head abnormality will be selected from Khoramabad's welfare centers. For random allocation, random numbers and randomized blocking methods will be used, so that the two groups will be matched according to the severity of the disease, age group, education level and BMI.
Afterward, the rate of Forward Head, the strength of neck flexors and extensors will be measured in both groups. The experimental group then participates in the corrective exercises program. During this course, the control group does not receive any intervention from the researcher. After completing the training program, the rate of Forward Head, the strength of flexors and extensors of the neck will be measured again and the data will be compared
Participants/Inclusion and exclusion criteria
Female
aged 15-25
come down with blind and low vision
having Forward Head abnormality
having cases in the welfare centers
having a radical discomfort or pain while exercising
having fractures or malignant infection in the neck area
unwillingness to do the exercises
Intervention groups
Experimental group: This group will participate in 60 minutes corrective exercises program, 3 sessions per week for 8 weeks.
Control group: Individuals in this group would not receive any intervention from the researcher and they only will complete the research questionnaires at the beginning and end of the research (after completing this study, corrective exercises will be made for the control group, too).
Main outcome variables
The rate of Forward Head abnormality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170514033961N5
Registration date:2018-08-05, 1397/05/14
Registration timing:retrospective
Last update:2018-08-05, 1397/05/14
Update count:0
Registration date
2018-08-05, 1397/05/14
Registrant information
Name
Mandana Saki
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3331 6465
Email address
m.saki@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks corrective exercises on Forward Head abnormality in blind and low vision women
Public title
The effect of corrective exercises on Forward Head abnormality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being female
Have 15-25 years old
Is blind or low vision
Having forward head abnormality
Having cases in the welfare centers
Exclusion criteria:
Having a radical discomfort or pain while exercising
Having fractures or malignant infection in the neck
Unwillingness to do exercises
Age
From 15 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Samples with inclusion criteria based on stratified-block randomization will be allocated into two groups of intervention group (corrective exercises) and control group (without any additional intervention by the researcher)
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 Lorestan University of Medical Sciences
Street address
Vice chancellor for research and technology, Lorestan University of Medical Sciences, Pardis Campus, Khorramabad-Boroujerd Road, Khorramabad, Lorestan
City
khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2017-02-20, 1395/12/02
Ethics committee reference number
LUMS.REC.1395.221
Health conditions studied
1
Description of health condition studied
Forward Head abnormality
ICD-10 code
M95.2
ICD-10 code description
Other acquired deformity of head
Primary outcomes
1
Description
Forward Head rate
Timepoint
At the beginning of the study (before the intervention) and one week after the completion of training sessions
Method of measurement
By the lane line
Secondary outcomes
1
Description
Strength of the neck extensors and flexors
Timepoint
At the beginning of the study (before the intervention) and one week after the completion of training sessions
Method of measurement
Isometr machine
Intervention groups
1
Description
Intervention group: this group will participate in 60 minutes corrective exercises program, 3 sessions per week for 8 weeks.
Category
Rehabilitation
2
Description
Control group:individuals in this group would not receive any intervention from the researcher and they only will complete the research questionnaires at the beginning and end of the research (after completing this study, corrective exercises will be made for the control group, too)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Welfare centers of Khorramabad
Full name of responsible person
Mandana Saki
Street address
No. 18, Rose Alley, Enghelab Avenue
City
Khorramabad
Province
Lorestan
Postal code
6819834525
Phone
+98 66 3331 6465
Fax
+98 66 3331 6465
Email
mandana_saki@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Morovat Taheri Kalaani
Street address
Vice chancellor for research and technology, Lorestan University of Medical Sciences, Pardis Campus, Khorramabad-Boroujerd Road
City
khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3312 0172
Fax
+98 66 3312 0172
Email
edu_res@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
90
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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mandana Saki
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 18, Rose Alley, Enghelab Avenue
City
Khorramabad
Province
Lorestan
Postal code
6819834525
Phone
+98 66 3331 6465
Fax
+98 66 3312 0140
Email
mandana_saki@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mandana Saki
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 18, Rose Alley, Enghelab Avenue,
City
Khorram-abad
Province
Lorestan
Postal code
6819834525
Phone
+98 66 3331 6465
Fax
+98 66 3312 0140
Email
mandana_saki@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mandana Saki
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 18, Rose Alley, Enghelab Avenue
City
Khorramabad
Province
Lorestan
Postal code
6819834525
Phone
+98 66 3331 6465
Fax
+98 66 3312 0140
Email
mandana_saki@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data will be published after unidentifying individuals in the form of information about the main outcomes.
When the data will become available and for how long
Access period will start since 2019
To whom data/document is available
All researchers, teachers, and medical students can receive the published article from the relevant journal
Under which criteria data/document could be used
Undisclosed data will be available to health science researchers for meta-analysis.
From where data/document is obtainable
Send email to Mandana Saki mandana_saki@yahoo.com
What processes are involved for a request to access data/document
After submitting the document by applicant researcher through email, the data will be sent two weeks later.