Comparison of the immediate effects of flexion control collars and flexion-extension control collars on neck range of motion and eye-hand coordination in healthy people
Determining the immediate effect of flexion control collars and flexion-extension control collars on neck range of motion and eye-hand coordination in healthy people
Design
this is a cross over clinical study study and each participant will receive all the interventions of the study in one session and randomly.
In this research, 54 healthy people are selected non-randomly from the students and staff of the rehabilitation faculty of Isfahan University of Medical Sciences by easy and accessible sampling method. In this way, each participant will receive all interventions and tests in one session and randomly. The age range of participants will be 18 to 45 years
Settings and conduct
The tests of this study will be conducted in the Musculoskeletal Research Center located in the Faculty of Rehabilitation Sciences of Isfahan University of Medical Sciences and the facilities located in this center will be used.
The study tests will include tests to evaluate the coordination of eye, hand and head movements, measuring the range of motion of the cervical spine, cervical proprioception, and postural sway.
Participants/Inclusion and exclusion criteria
healthy people with normal balance and vision
Intervention groups
Intervention 1: flexion control collar, with a chin support to limit the neck flexion movement,
Intervention 2: flexion-extension control collar, with chin support and occipital support to limit the neck flexion and extension movements.
size selection Suitability of both collars is based on the size of the circumference and height of the neck. Both collars are made of polyurethane foam, prepared prefabricatedly from Behbood Teb Company (Iran-Tehran).
Third condition: without intervention (without collar).
Main outcome variables
cervical spine range of motion; eye-hand coordination; eye-head coordination; reaction time; proprioception; postural sway
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231226060525N1
Registration date:2024-06-08, 1403/03/19
Registration timing:registered_while_recruiting
Last update:2024-06-08, 1403/03/19
Update count:0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Narges Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3345 1178
Email address
n.karimi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the immediate effects of flexion control collars and flexion-extension control collars on neck range of motion and eye-hand coordination in healthy people
Public title
Comparison of the immediate effects of flexion control collars and flexion-extension control collars on neck range of motion and eye-hand coordination in healthy people
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
healthy people with normal vision and balance
Exclusion criteria:
with history of orthopedic problems including fracture, trauma and surgery in head, neck, upper extremity and thoracic and lumbar spine
with history of deformities in neck and chronic neck pain
with history of neurologic, rheumatoid and psychologic disorders
with history of Endocrine and connective tissue diseases
with visual problems
with diabetic and cardiovascular disease
with vestibular system pathologies
taking drugs that affect the patient's hand and head coordination and balance
Age
From 18 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
The conditions of the study interventions are determined through randomization, and each participant will receive all the study conditions randomly during one session. Randomization is done by drawing the concealed envelope containing the lot from a bag. The randomization unit is the intervention condition (3 study modes including no intervention, with flexion-control collar, and with flexion-extension control collar). In this study, randomization is done to select randomly the condition of the interventions. It is not used in randomly allocating participants to groups, because only one group of people is studied in this study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
This study is considered as a proof-of-concept study and this design is actually the initial stage of the idea so that the relationship between the limitations created by the structural features of collars and the eye hand coordination movements can be evaluated. Based on this and also due to ethical considerations, the upcoming project is conducted as a preliminary study on healthy people, then its results can be used for future studies on diseases such as cerebral palsy and spondylosis.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Nursing, Management and Rehabilitation - Isfahan University of Medica
Street address
No. 5, Taleghani Dead End, Shariati St., Shahidardanipur Highway
City
isfahan
Province
Isfehan
Postal code
8138878611
Approval date
2023-12-23, 1402/10/02
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.156
Health conditions studied
1
Description of health condition studied
In this study, no specific disease is considered, but a preliminary study is conducted on healthy people.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Average range of motion of cervical spine
Timepoint
Variable is measured in one session and after performing the relevant test.
Method of measurement
Using the inertial measurement unit tool to measure the range of motion of the cervical spine, modules are inertial measurement units include three three-axis gyroscope sensors, three-axis accelerometer and three-axis magnetometer, which respectively measure angular velocity, acceleration and magnetic field. These modules are placed on the body parts using straps to measure the movements of each body part. The position of the sensor to measure the range of motion of the cervical spine in our study is considered forehead. Also, another module is placed on the trunk at the level of the eighth thoracic vertebra as a reference module.
2
Description
eye-hand/head coordination
Timepoint
Variable is measured in one session and after performing the relevant test.
Method of measurement
Minnesota Manual Dexterity Test: It consists of 60 cylindrical discs, one side of which is red and the other side is black, as well as a black plastic board, with dimensions of 85.4 centimeter in length, 22.8 centimeter in width and 0/5 centimeter depth, in which holes with 15x4 pattern are created. This test consists of two sub-set tests called the Placing test (use of the dominant hand) and the Turning test (simultaneous use of both hands). In this study, the Placing test is used.
3
Description
eye-hand/head coordination
Timepoint
Variable is measured in one session and after performing the relevant test.
Method of measurement
Nine Hole Peg Test : It consists of a square plate with 9 holes that are placed in the center of the holes at a distance of 2.3 centimeter from each other. The depth of each hole is 1.3 centimeter and the length of its radius is 2.3 centimeter. There is also a holder to hold the pins.
4
Description
reaction time
Timepoint
Variable is measured in one session and after performing the relevant test.
Method of measurement
Psychology Experimental Building Language software: Spatial priming test is used in this software. Spatial priming test consists of a square board divided into 3x3 squares. The participant sits in front of the touchscreen, a square screen appears in front of him. At the beginning of each test, one of the nine squares turns blue and the person must touch that square with his finger as quickly and accurately as possible. During a test, this square screen appears 45 times.
5
Description
cervical proprioception
Timepoint
Variable is measured in one session and after performing the relevant test.
Method of measurement
Using the inertial measurement unit tool, modules are inertial measurement units include three three-axis gyroscope sensors, three-axis accelerometer and three-axis magnetometer, which respectively measure angular velocity, acceleration and magnetic field. These modules are closed using a strap on the forehead and around the chest to measure movements.
6
Description
postural sway
Timepoint
Variable is measured in one session and after performing the relevant test.
Method of measurement
Using the inertial measurement unit tool, modules are inertial measurement units include three three-axis gyroscope sensors, three-axis accelerometer and three-axis magnetometer, which respectively measure angular velocity, acceleration and magnetic field. These modules are closed by straps around the lumbar region and at the level of the fifth lumbar vertebra.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: Flexion control collar, this collar has a chin pad/support that limits cervical flexion movement. This collar anteriorly extends from the mandible to the sternal notch. Collar is made of polyurethane foam and it is prepared in a prefabricated style from Behboh Teb Company (Iran-Tehran). The appropriate size of collar is determined based on the size of the circumference and height of the neck. Collar is prepared in 4 sizes and is fastened on the participants' neck by the researcher according to the manufacturer's instructions.
Category
Rehabilitation
2
Description
Intervention 2: Flexion-extension control collar, this collar has a chin pad and occipital pad that limit cervical flexion and extension movements. collar is made of polyurethane foam and it is prepared in a prefabricated style from Behboh Teb Company (Iran-Tehran). The appropriate size of collar is determined based on the size of the circumference and height of the neck. Collar is prepared in 4 sizes and is fastened on the neck of the participants by the researcher according to the to the manufacturer's instructions.
Category
Rehabilitation
3
Description
Control group: The third mode of study without intervention, in this study each person is considered as his/her control. Thus, in the third condition of the study, no intervention is done during the tests, and the results of the tests in this condition are compared with the results of the tests in the condition with intervention. In the third condition, without intervention, no collar is tied around the person's neck and the person performs all the tests without the collar.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Musculoskeletal Disorders Research Center, Faculty of Rehabilitation, West Gate of Isfahan Universit
Full name of responsible person
narges karimi
Street address
No. 5, Taleghani dead end, Shariati St., Shahid Redanipur highway
City
isfahan
Province
Isfehan
Postal code
8138878611
Phone
+98 31 3792 5229
Email
msrc@rehab.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Research and Technology Vice-Chancellor, Building No. 4, Isfahan University of Medical Sciences and Health Care Services, Hazar Jarib St.
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
ابراهیم صادقی
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
orthotics and prosthetics
Street address
Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences and Health Services, Hazar Jarib St.
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Email
sadeghi@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
ebrahim sadeghi demneh
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
orthotics & prosthetics
Street address
Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences and Health Services, Hazar Jarib St.
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Email
sadeghi@rehab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
narges karimi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
orthotcis & prosthetics
Street address
No. 5, Taleghani dead end, Shariati St., Shahid Redanipur highway
City
isfahan
Province
Isfehan
Postal code
8138878611
Phone
+98 21 8670 5503
Email
narges.karimi127@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