Comparative study of stabilization exercise and kinesiotaping on neck proprioception and craniovertebral angle in subjects with forward head posture
Design
Clinical trial, community-based and pragmatic, with parallel groups, randomized, without control with placebo, single center trial.
Settings and conduct
Neuromuscular Rehabilitation Research Center.
Participants are divided into 3 groups. According to the protocol are going under treatment for 3 sessions a week.The neck angle reconstruction error is measured using a digital goniometer at before intervention, after 4 weeks and one month after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Girls 18-35 years; Craniovertral angle is more than 54 degrees; subjects with forward head posture.
Exclusion criteria: subjects with forward head posture; High blood pressure; Diabetes; Traumatic injury of the vertebral column.
Intervention groups
Intervention group 1: 33 persons according to the protocol are attached the sports glue or the kinesiotype to the back and neck area.
Intervention group 2: 33 persons according to the protocol are going under treatment with stability exercises for 3 sessions a week.
Intervention group 3: 33 persons who have sport glue or the kinesiotype on the back and neck area. According to the protocol are going under treatment with stability exercises for 3 sessions a week.
In all three groups, the neck angle reconstruction error is measured using a digital goniometer at before intervention, after 4 weeks and one month after the intervention.
Main outcome variables
Error evaluation of the angle of neck reconstruction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N41
Registration date:2019-07-14, 1398/04/23
Registration timing:registered_while_recruiting
Last update:2019-07-14, 1398/04/23
Update count:0
Registration date
2019-07-14, 1398/04/23
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-18, 1397/09/27
Expected recruitment end date
2019-12-17, 1398/09/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of stabilization exercise and kinesiotaping on neck proprioception and craniovertebral angle in subjects with forward head posture
Public title
Comparative study of stabilization exercise and kinesiotaping on neck proprioception and craniovertebral angle in subjects with forward head posture
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 35 years
Craniovertral angle is more than 54 degrees
subjects with forward head posture
Exclusion criteria:
Neck surgery
High blood pressure
Diabetes
Traumatic injury of the vertebral column
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated randomly with simple sequential allocation in one of the three study groups by help of sealed envelope and receive the intervention of the same group. The unit of randomization will be the referred patient. The sealed envelopes will be placed at the disposal of the expert. With the referral of each patient one of the envelopes will be randomly selected by the patients and will be introduced as a study group. The stratification approach is not used. Concealment will not take place in the study.
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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.SEMUMS.REC.1397.216
Health conditions studied
1
Description of health condition studied
Neck injury
ICD-10 code
S19.8
ICD-10 code description
Other specified injuries of neck
Primary outcomes
1
Description
Error evaluation of the angle of neck reconstruction
Timepoint
Before, after 4 weeks and one month after the intervention period
Method of measurement
Dualer IQ™ digital Inclinometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 33 persons according to the protocol are attached the sports glue or the kinesiotype to the back and neck area. The neck angle reconstruction error is measured using a digital goniometer at before intervention, after 4 weeks and one month after the intervention.
Category
Rehabilitation
2
Description
Intervention group 2: 33 persons according to the protocol are going under treatment with stability exercises for 3 sessions a week.The neck angle reconstruction error is measured using a digital goniometer at before intervention, after 4 weeks and one month after the intervention.
Category
Rehabilitation
3
Description
Intervention group 3: 33 persons who have sport glue or the kinesiotype on the back and neck area. According to the protocol are going under treatment with stability exercises for 3 sessions a week.The neck angle reconstruction error is measured using a digital goniometer at before intervention, after 4 weeks and one month after the intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Atefe Aminianfar
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
Ehsani98@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
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
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Aminianfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atefe Aminianfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Somayeh Parishan
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
Only available to scholars working in academic institutions.
Under which criteria data/document could be used
In case of relevant studies.
From where data/document is obtainable
Atefeh Aminianfar.
Neuromuscular Rehabilitation Research Center, Ghods Blvd. +98 9127312407
What processes are involved for a request to access data/document