The purpose of this study is to compare the perception of knee joint position sense before and after rhythmic full squat protocol and to investigate the effect of using kinesiotape on perception of knee position sense between MS patients and healthy controls.
Design
Participants who were included are the control group (healthy) and the group of patients with MS who were in their sedentary phase, aged 20-35 years, were enrolled in this study in a non-randomized controlled clinical trial. The main variable is variable error, calculating the sample size, indicate that at least 12 samples were needed . Samples are selected voluntary, simple and non-probability sampling based on entry and exit criteria.
Settings and conduct
In this study, the study population is relapsing-remitting MS patients and the sample is those referred to MS Research Center (Sina Specialty Hospital).
Participants/Inclusion and exclusion criteria
inclusion criteria are patients with RRMS with age range between 20-35 years with EDSS≤6 who has no history of Anemia, surgery, fracture, cardiopulmonary and neuro muscular diseases, Diabetes, hypothyroidism, depression according to PHQ-9 ≤15 questionnaire.The subjects would be excluded
from either group if they experienced any fatigue
or stress before testing or unable to learn or collaborate in the processes.
Intervention groups
In both groups 1 - Measuring the knee joint position sense with the help of goniometer
2- Perform a rhythmic full squat until it reaches level 13 based on the BORG questionnaire, which is actually somewhat hard
3. Re-measuring the participant's knee position sense
4- Measurement of the patient's position sense of knee joint with kinesiotape on quadriceps muscle
Main outcome variables
Fatigue after squatting
kinesiotape
MS disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200112046099N1
Registration date:2020-06-04, 1399/03/15
Registration timing:registered_while_recruiting
Last update:2020-06-04, 1399/03/15
Update count:0
Registration date
2020-06-04, 1399/03/15
Registrant information
Name
Saina Aliabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4442 1366
Email address
s_aliabadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-04, 1399/01/16
Expected recruitment end date
2020-10-07, 1399/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The immediate effect of kinesio taping of quadriceps muscle on position sense of knee joint following full squat in patients with multiple sclerosis
Public title
The immediate effect of kinesio taping of quadriceps muscle on position sense of knee joint following full squat in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Recurrent-relapsing MS patients
Disability level by Expanded Disability Status Scale ≤ 6 (EDSS)
Age between 20-35 years
Able to write and read
Muscle strength should be three or more in quadriceps and hamstrings muscles
No history of anemia
No depression according to Patient Health Questionnaire-9 (PHQ-9).
No history of Diabetes
No history of hypothyroidism
No illnesses that increase fatigue, such as myasthenia gravis
Not having disruptive spasticity in doing exercises
No history of surgery or fracture
No history of drug use in the past 6 months
No history of cardiopulmonary diseases
Complaints of fatigue that cause Disturbance in daily activities (should distinguish between extreme daytime sleepiness and fatigue).
Exclusion criteria:
Inadequate data recording
Decreasing one's motivation (not wanting to continue cooperation and intentionally declare score 13 in the fatigue questionnaire)
Patient Unables to learn the process
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Not randomized
Randomization description
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
National Committee on Ethics in Biomedical Research Tehran university of Medical Sciences
Street address
Floor 13, Block A, Headquarters of the Ministry Health and Medical Education, Simaye Iran street, Between south Falamak and Zarafshan, Qods town, Tehran
City
TEHRAN
Province
Tehran
Postal code
1148965111
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.TUMS.FNM.REC.1398.012
Health conditions studied
1
Description of health condition studied
Relapsing-remitting multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
1. Fatigue following rhythmic full squats, which is an independent variable , and based on the patient's self-expression is assessed using the BORG questionnaire, which has a range of 0-20, and when a person reaches a somewhat hard level, which is equivalent to 13 the full squat operation will not continue. 2. Kinesiotape, which is an independent nominal variable. 3. Multiple sclerosis, which is an independent nominal variable, relapsing remitting type of MS, which has been referred to us by a neurologist.
Timepoint
At first, the participant's knee joint was measured with the help of a goniometer, and then he was asked to perform a full rhythmic squat until the moment, according to the BORG questionnaire at level 13, which is actually somewhat hard. The participant's knee position was then re-measured to assess changes in position sense error following rhythmic full squats. In the next step, the kinesiotape was first applied to three of the four heads of quadriceps muscle, and then the patient's knee condition was measured again to asses position sense errors following therapeutic intervention (taping). In the final stage, the person performed a rhythmic full squat protocol on the muscle and the kinesiotape applied on muscle to check for changes in position sense errors following fatigue associated with taping.
Method of measurement
Kinesiological tape to examine its therapeutic effect in compense participant's fatigue and its effect on position sense and using a standard goniometer to assess the patient's position sense (reconstruction from 90 degrees to 45 degrees of knee flexion)
Secondary outcomes
1
Description
position sense (including absolute, variable, and constant errors in angle reconstruction) that is a continuous dependent variable and is measured by the variance of the reconstructed angle. it measures with software and Goniameter and camera.
Timepoint
Before and after performing the full squat protocol, after attaching the kinesiotape on the quadriceps muscle, and finally after performing the full squat protocol while the tape is attached to the muscle.
Method of measurement
To test the position sense, a 16-megapixel Canon camera with a camera lens distance from the patient (80 cm) and a camera height from the ground (70 cm) was first placed. using markers on land marks was then performed on standard areas (greater trochanter of femur, lateral condyle offemur, head of the fibula, and lateral malleolus of the dominant limb). The patient then sat on the edge of the bed with his eyes closed so that his knees were at 90 degrees of flexion and the opposite leg was fixed on an adjustable, motionless stand. With a standard goniometer, the fixed arm of goniameter was placed on the thigh and the movable arm of goniameter was placed on the leg (fibula), the desired angle (about 45 degrees) was determined for the patient, so that the person should test this angle without a manual contact. It was kept for 5 seconds and then the patient was asked to return to the starting position (90 degree angle). The patient was then asked to raise his legs from 90 to 45 degrees with his eyes closed, and whenever he felt that his knee had been raised from 90 to 45 degrees, he would use a laser to flash on the front wall. The moment the laser light was seen, the reconstructed image was immediately photographed. The reconstruction was performed four times with a 5-second break between each repetition. Images were analyzed by the software in Excel environment and changes in the absolute, variable and constant errors of position sense were calculated.
Intervention groups
1
Description
Intervention group: MS group with relapsing remitting MS, Control group: Healthy people. Both groups will receive a similar intervention in a treatment session that includes measuring the position sense of knee joint in four stages: a) before fatigue, b) after fatigue, when we ask the participant to stand near the edge of the bed and do a rhythmic squat with a steady metronome, and when he feels he has reached level 13 of the BORG (somewhat hard) questionnaire, the protocol will stop.c) 30-40% traction of kinesiotape on the three heads of the quadriceps muscle is attached. And d) Taping and fatigue is combined with the use of a limitator. At each step, we take a picture with a 16-megapixel Canon digital camera that it's validity and reliability have been established.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
research center of MS in Sina Hospital
Full name of responsible person
Saina Aliabadi
Street address
Sina hospital, Hasan abad square, Imam Khomeini street, Tehran
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6634 8571
Email
s_aliabadi@razi.tums.ac.ir
Web page address
http://sinahospital.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Gholam Reza Olyaei
Street address
Rehabilitation Faculty, Piche Shemiran, At the coner of Safi Ali Shah Street,Enghelab Street, Tehran
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 3939
Fax
Email
Olyaeigh@sina.tums.ac.ir
Web page address
http://rehab.tums.ac.ir/
Grant name
Vice chancellor for research of Tehran university of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Saina Aliabadi
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation school, In the corner of Safi Ali Shah street, Piche Shemiran, Enghelab street, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
s_aliabadi@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghola Reza Olyaei
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation school, At the corner of Safi Ali Shah Street, Piche Shemiran, Enghelab Street, Tehran
City
TEHRAN
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
olyaeigh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saina Aliabadi
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation school, At the corner of Safi Ali Shah street, Piche Shemiran, Enghelab street, Tehran
City
TEHRAN
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Fax
Email
aliabadi.saina@gmail.com
Web page address
http://rehab.tums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD