Protocol summary

Study aim
Examining the effect of kinesio tape on dynamic balance using the Y test before and after the use of tape in women and men and comparing the impact of kinesio tape on dynamic balance between the two groups of women and men with patellofemoral pain syndrome.
Design
Non- randomized Quasi Experimental clinical Trial
Settings and conduct
Physical therapy clinic of shahid Sadoughi Hospital in Isfahan
Participants/Inclusion and exclusion criteria
Inclusion criteria: subject from both genders with patellofemoral pain Exclusion criteria:other problem and diseases associated with knee pain and participants balance
Intervention groups
Two groups of women and men: Kinesio tape is bonded to kenzo kase method for the correction of the external glide patella. The tape is measured on the patient's patella that is to be corrected. Cut the tape and use Y's cutting in this technique. 2 cm First, fasten the base without tension out the patella when it is flat or bent 20 to 30 degrees. We hold our hands on this piece, and pull the base with a stretch of 50-75%, along with a patella to the inside. The tape is drawn to the inside and the bottom. To the middle of the patella, the base of the patella ends and knees bend while fastening the tape and patella correction. While we hold the base of the patella and bend the knee, the first trail is fastened 15 to 25 percent tension to the top of the patella and the second trail with the same stretch is fastened to bottom of the patella. Finally, the final part of the trails fasten tensile-free. before and after the tape, the dynamic balance is measured by the Y test.
Main outcome variables
pain; dynamic balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181001041197N1
Registration date: 2018-11-03, 1397/08/12
Registration timing: registered_while_recruiting

Last update: 2018-11-03, 1397/08/12
Update count: 0
Registration date
2018-11-03, 1397/08/12
Registrant information
Name
Zainab Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3260 0441
Email address
zainab.hosseini62@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-15, 1397/04/24
Expected recruitment end date
2019-03-15, 1397/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Kinesio Taping on Dynamic Balance between Male and Female with unilateral Patellofemoral Pain Syndrome (PFPS)
Public title
Comparison of the Effect of Kinesio Taping on Dynamic Balance between Male and Female with unilateral Patellofemoral Pain Syndrome (PFPS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence anterior or retro patella Pain only in one leg The report of pain at least in two of the functional activities throughout the day: squatting, running, climbing, kneeling and prolonged sitting The pain will be reported in the single leg squat test on the leg involved at 45 degree angle for 10 seconds Score of at least 3 by the person himself on the visual analog scale (VAS) The McConnell test shows lateral glide No received any rehabilitation treatment for knee joint for 3 months before entering the study. Inactivity in certain sports Gradual onset of pain for at least 8 weeks Age between 18-40 years
Exclusion criteria:
Traumatic, inflammatory and inflammatory lesions in the lower extremities Dislocation and subluxation of the patella History of surgery on the knees and the areas of the lower back, pelvis or lower extremities Any signs of knee osteoarthritis in X-ray The presence of fractures or deformities in the knees and lower extremities 135 degree knee limitation in sagittal plane History of neurological, rheumatologic and musculoskeletal disorders in lower limbs History of dizziness, uncorrected vision problems and internal ear disorders Pain in the waist, pelvis and sacroiliac The presence of lower limb dysfunction Corticosteroid injections and receivied physiotherapy in the last 3 months and receivied opioid and analgesic drugs in the last 72 hours
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 38
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Participants are divided into two groups of women and men, and a homogeneous intervention (kinesio Tape) is applied to both, before and after tape, each group is evaluate, and then the two groups are compared.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Secretariat of the Ethics Committee, Room 209, Second Floor, Building No. 4, Isfahan University of Medical Sciences,Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81745-164
Approval date
2018-07-15, 1397/04/24
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.040

Health conditions studied

1

Description of health condition studied
patellofemoral pain syndrome
ICD-10 code
M22.4
ICD-10 code description
Chondromalacia patellae

Primary outcomes

1

Description
dynamic balance
Timepoint
before and after intervention
Method of measurement
Y balance test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In both groups, men and women undergo intervention. In both groups, the kinesio tape is applied onto the patella to correct the alignment.This research is done on two groups of women and men with patello femoral pain syndrome, aged 18 to 40 years. The sample size for each group is 19 people. Individuals are enrolled in the study through convenient sampling. After examining the criteria for entry and exit by the physiotherapist and completing the consent form and demographic form, the subjects are enrolled and the ability to maintain balance is examined through the Y balance test. To perform the Y test, the barefoot person stands in the center of the way and performs 6 times to avoid learning effects in each direction. Then rest for 5 minutes and again at the center of the Y-shaped marks with the affected foot and in each direction performs 3 times the test with a healthy foot. We calculate the maximum recorded distance in each direction and divide it by the length of the lower limb and then multiply in 100 to achieve distance by percentage of foot length. This test is performed on the affected limb, in conditions with and without tape. Their balance is determined through the Y balance test before and after the intervention. Patients' pain intensity is determined by the Visual Analog Scale (VAS), in which the person is told to squat one leg up to a 45 degree angle and hold it for 10 seconds, and then they are asked to rate their pain. Line 10 cm. The zero number represents painless, and the number 10 represents the maximum amount of pain imaginable. People undergoing pain should have at least 3 upwards that are considered in the criteria for entry. The second stage of the test, after 5 minutes of rest, occurs at this stage, the person lying on the bed and limb Involved, with the aim of creating a medial glide, by kinesiotape, with a stretching of 50-75%. In this study, the Temtex TKT-012 kinesiology tape is used. The efficiency of the taping technique is reduced by about 50% in the intensity of pain, after the patella taping compared to the previous one after a single leg squat test. Otherwise, the taping will be repeated again. Once again, the severity of pain is recorded by the visual analog scale (VAS) after the taping, and the Y balance test is also performed.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Sadoghi hospital
Full name of responsible person
Zainab hosseini
Street address
Bozorgmehr street; Sadoghi hospital
City
Isfahan
Province
Isfehan
Postal code
8153899987
Phone
+98 31 3260 0441
Email
zainab.hosseini62@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Hagh joy Javanmard
Street address
Hezar Jerib St., Isfahan University of Medical Sciences,Building 4 headquarters, deputy research and technology
City
Isfahan
Province
Isfehan
Postal code
81745-164
Email
mostamand@rehab.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Dr Javid Mostamand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar jerib street., Isfahan University Medical Science; Faculty of Rehabilitation Sciences,
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
+98 312600441
Email
zainab.hosseini62@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Javid Mostamand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar jerib street; Isfahan University Medical Science; Faculty of Rehabilitation Sciences
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
+98 312600441
Email
mostamand@rehab.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
dr Javid Mostamand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
hezar jerib street; Isfahan University of Medical Sciences, Faculty of Rehabilitation Sciences
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
+98 31 3260 0441
Email
mostamand@rehab.mui.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
No more information
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
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