Protocol summary

Study aim
Main goals : 1) Comparing upper cervical and cranium joint dysfunctions between normotensive and hypertensive groups by measuring neck muscle thickness using sonographic data 2)Comparing changes of instantaneous blood pressure before and after of eye gaze exercise therapy 3)Considering dynamic MRI as a measurement tool for cranial rhythmic impulse measurement /comparing cranial rhythmic impulse between normotensive and hypertensive groups using dynamic MRI
Design
Randomized Control Trial
Settings and conduct
Rehabilitation sonography device Dynamic MRI Biofeedback Heart Rate Variability sensor Laser Headset for Range Of Motion
Participants/Inclusion and exclusion criteria
Hypertension systolic blood pressure 13 to 17.9 mmHg Hypertension Diastolic blood pressure 80 to 11.9 mmHg Age 20-50 Primary hypertension ( atherosclerosis ) Cardiac disease Renal disease Pulmonary disease Vertebral malalignment Surgery history Age higher than 50
Intervention groups
one group will receive eye gaze exercises and the other group will receive placebo ( just staring at a point , not to move head or eye )
Main outcome variables
Sonographic (CSA) data of deep neck flexors and extensors Dynamic MRI of cranium for cranial rhythmic impulse Heart rate variability Neck ROM

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190815044535N1
Registration date: 2023-03-05, 1401/12/14
Registration timing: registered_while_recruiting

Last update: 2023-03-05, 1401/12/14
Update count: 0
Registration date
2023-03-05, 1401/12/14
Registrant information
Name
Pezhman Masoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2285 7585
Email address
masoudip2002@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing upper cervical and cranium joint dysfunctions by measuring sonographic data of muscles / Effect of eye movement exercises on instantaneous blood pressure changes in hypertensive and normotensive groups with craniocervical joint dysfunctions
Public title
Cervicocranium joint dysfunctions / eye movement exercise blood pressure effects in normotensive and hypertensive groups
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Hypertension systolic blood pressure 13 to 17.9 mmHg Hypertension Diastolic blood pressure 80 to 11.9 mmHg Age 20-50
Exclusion criteria:
Primary hypertension ( atherosclerosis ) Cardiac disease Renal disease Pulmonary disease Vertebral malalignment Surgery history Age higher than 50 Taking drugs for hypertension
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized block design
Blinding (investigator's opinion)
Single blinded
Blinding description
The groups will be blind to procedure of exercise therapy and the way it may work to reduce blood pressure
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of university of social welfare and rehabilitation
Street address
Daneshyar alley , Daneshjooo Blv , Daneshjoo Square , Velenjak, Tehran
City
tehran
Province
Tehran
Postal code
1985713871
Approval date
2023-03-02, 1401/12/11
Ethics committee reference number
IR.USWR.REC.1401.237

Health conditions studied

1

Description of health condition studied
Hypertension, Cervicocranium joint dysfunction
ICD-10 code
I15
ICD-10 code description
Secondary hypertension

Primary outcomes

1

Description
Instantaneous blood pressure
Timepoint
Before and just after intervention
Method of measurement
Blood pressure measuring device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: hypertensive group with cervicocranium joint dysfunction which receives eye movement exercise therapy
Category
Treatment - Other

2

Description
Control group: hypertensive group with cervicocranium joint dysfunction which receives placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy research laboratory of university of social welfare and rehabilitation
Full name of responsible person
Pezhman Masoudi
Street address
Daneshyar alley , Daneshjooo Blv , Daneshjoo Square , Velenjak, Tehran
City
tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2420
Email
masoudip2002@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
karimi nouredin
Street address
Daneshyar alley , Daneshjooo Blv , Daneshjoo Square , Velenjak, Tehran
City
tehran
Province
Tehran
Postal code
1985713871
Phone
+98 912 257 3865
Email
karimi@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Nouredin karimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Daneshyar alley , Daneshjooo Blv , Daneshjoo Square , Velenjak, Tehran
City
tehran
Province
Tehran
Postal code
1985713871
Phone
+98 912 257 3865
Email
karimi@uswr.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
nouredin karimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Daneshyar alley , Daneshjooo Blv , Daneshjoo Square , Velenjak, Tehran
City
tehran
Province
Tehran
Postal code
1985713871
Phone
+98 912 257 3865
Email
karimi@uswr.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Pezhman Masoudi
Position
Ph.D. student
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Daneshyar alley , Daneshjooo Blv , Daneshjoo Square , Velenjak, Tehran
City
tehran
Province
Tehran
Postal code
1985713871
Phone
+98 912 457 6948
Email
masoudip2002@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
Part of data including interventional part of study would be available if asked .
When the data will become available and for how long
After 4 months if not required by journals or other organizations, data would be vanished
To whom data/document is available
Journals , Research committee
Under which criteria data/document could be used
Future related researches
From where data/document is obtainable
To first author
What processes are involved for a request to access data/document
Asking by sending email to first author
Comments
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