According to the role of hip abductor muscles in controlling balance and their function in preventing falls in the elderly, the purpose of this research is to study the immediate effect of hip abductors muscles Kinesio Taping before and after induction of fatigue in elderly population.
Design
a randomized, triple-blinded, sham-controlled clinical trial with a parallel group design of 13 participants in each group which were randomized by concealed cards put in a pocket.
Settings and conduct
The study was carried out in the biomechanic laboratory of Tehran University of medical sciences. Firstly, the balance tests were assessed. Then KT was applied to hip abductor muscles followed by assessing balance tests. Finally, muscle fatigue was induced followed by assessment of balance tests.
Participants/Inclusion and exclusion criteria
eligibility criteria: age between 60 to 75 years old, independence of instrumental walking aids, ability to perform activities of daily living independently.
The following are not eligible for the study: decompensated heart failure, neurological or muscular disease, significant visual changes, complaints of dizziness, history of hip or knee arthroplasty, unconsolidated fractures, open wounds or scar tissues in the region of applying KT.
Intervention groups
Intervention group: applied KT with tension
Control group: Applied KT without tension26
Main outcome variables
Single leg stance test; maximum gait speed; star excursion balance test
General information
Reason for update
Acronym
KT = kinesiotape
IRCT registration information
IRCT registration number:IRCT20230205057324N1
Registration date:2023-03-11, 1401/12/20
Registration timing:registered_while_recruiting
Last update:2023-03-11, 1401/12/20
Update count:0
Registration date
2023-03-11, 1401/12/20
Registrant information
Name
Mohsen Rezvani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4221 8531
Email address
pt.rezvani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Immediate effect of hip abductor muscles kinesio taping on static and dynamic balance before and after muscular fatigue induction in elderly people
Public title
Immediate effect of hip abductor muscles kinesio taping on static and dynamic balance before and after muscular fatigue induction in elderly people
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age between 60 and 75 years old
independence for using instrumental aids
independence for activities of daily living
normal or controlled blood pressure with medicine
Exclusion criteria:
decompensated Heart Failure
neurologic diseases or conditions such as MSA, TBI, CVA, MS and CP
presence of muscular dysfunctions such as myopathies, fibrositis and MG
presence of dizziness
complains of visual problems which interfere with balance control
history of knee or hip arthroplasty surgery
presence of unconsolidated fractures
diabetes mellitus interfering with detection of application in the soles of the feet
presence of open wounds in lower limbs
presence of unhealed scar tissues in the region of applying KT
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be based on a single sequence (simple randomization) and the random number table method will be used, so that the table is read from the above and even numbers are considered for the intervention group (Kinesio taping with tension) and odd numbers are for the control group. allocation concealment will be done using sealed opaque envelopes and each of the random sequences will be recorded on a card and the cards will be placed inside the envelopes. In the end, after gluing the lid of the envelopes they will be placed inside a box. 26 envelopes will be placed inside the box. at the beginning of the study, one of the envelopes will be opened in order and the assigned group for each participant will be revealed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants will be aware of the method of taping being used on them, but they will not be aware of which group they have been allocated to. Participants are not aware of how the KT is used for the other group. Participants will not meet each other.
The evaluating researcher does not know which group the participants belong to and a comfortable wearing hides the region in which KT is applied.
The data analyzer is blinded for the Sham or Intervention group and knows the groups by the name 1 and 2.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No. 179, Somayyeh Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۵۸۱۷۴۹۷۱۱
Approval date
2023-02-01, 1401/11/12
Ethics committee reference number
IR.TUMS.FNM.REC.1401.159
Health conditions studied
1
Description of health condition studied
-
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
single leg stance time
Timepoint
Baseline assessment, after applying KT, after inducing muscle fatigue
Method of measurement
stopwatch
2
Description
reached distances in Star Excursion Balance Test
Timepoint
Baseline assessment, after applying KT, after inducing muscle fatigue
Method of measurement
tape measure
3
Description
Maximum gait speed
Timepoint
Baseline assessment, after applying KT, after inducing muscle fatigue
Method of measurement
utilization of speed measurement formula (distance divided by time)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Gluteus Medius excitatory taping method was used for the intervention group. 2 I shaped tapes in which only the middle third was held in 35% tension was attached to the skin, one from the anterior part of the Iliac crest to the greater trochanter of the femur, and the other from the posterior part of the iliac crest to the greater trochanter of the femur. tape length was measured for each individual separately. Messon KT made in China was utilized in this study. In this brand of KT, in a 10-centimeter cut of tape, when held in 35% tension, a 2-centimeter increase in length happens.
Category
Rehabilitation
2
Description
Control group: only one I shape piece of KT with no tension in horizontal direction will be placed in the lateral side of hip joint, on the skin of abductor muscles region.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation school of Tehran University of Medical Sciences
Full name of responsible person
Mohsen Rezvani
Street address
No 179, Somayyeh Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۵۸۱۷۴۹۷۱۱
Phone
+98 51 4221 8531
Email
pt.rezvani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Vice Chancellor for research and Technology, Sixth Floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3639
Email
research@tums.ir
Grant name
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
Mohsen Rezvani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 179, Somayye Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۵۸۱۷۴۹۷۱۱
Phone
+98 51 4221 8531
Email
pt.rezvani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nastaran Ghotbi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of rehabilitation, Piche-Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
nghotbi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohsen Rezvani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 179, Somayyeh Street, Tehran
City
Tehran
Province
Tehran
Postal code
۱۵۸۱۷۴۹۷۱۱
Phone
+98 51 4221 8531
Fax
Email
pt.rezvani@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data will be available after unidentification.
When the data will become available and for how long
The access period starts 3 months after the article is published
To whom data/document is available
For researchers working in academic, scientific and hospital institutions.
Under which criteria data/document could be used
Researchers working in the field of elderly rehabilitation
From where data/document is obtainable
Applicants could contact Mr. Rezvani via E-mail: pt.rezvani@gmail.com
What processes are involved for a request to access data/document
After identification of the aplicant, the data will be sent to their mail.