The Immediate and Short-term Effects of Facilitatory Kinesiotaping of Gastrocnemius on Electrical Activity of the Muscle and Dynamic Balance in Healthy Nonathelete Middle-age Men (Double Blinded Randomized Control Trial)
To evaluate the effects of gastrocnemius facilitatory kinesiotaping on the muscle activity and dynamic balance in non-athletic middle-aged men
Design
Randomized double blinded clinical trial, with sham group, community based, pragmatic, parallel group
Settings and conduct
Electero-diagnosis Research Center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences. Participants, care provider, outcome assessor and the analyzer are blind.
Participants/Inclusion and exclusion criteria
Non-athletic healthy middle-age men between 40-65 years old will be included and those with the history of musculoskeletal condition and balance defects, regular exercise, pain and inability to perform the test will not be included.
Intervention groups
in intervention group the facilitatory gastrocnemius taping will be applied according to the manual by Kinesiotaping International Association. in sham group only anchor and end will be applied with no tension
Main outcome variables
Root Mean Square of Surface EMG records of medial and lateral gastrocnemius; Y balance records in anterior, posteromedial and posterolateral direction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150131020888N8
Registration date:2018-02-11, 1396/11/22
Registration timing:retrospective
Last update:2018-02-11, 1396/11/22
Update count:0
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
Zahra Sadat Rezaeian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5042
Email address
zrezaeian@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2017-02-20, 1395/12/02
Expected recruitment end date
2017-12-20, 1396/09/29
Actual recruitment start date
2017-02-20, 1395/12/02
Actual recruitment end date
2017-07-22, 1396/04/31
Trial completion date
empty
Scientific title
The Immediate and Short-term Effects of Facilitatory Kinesiotaping of Gastrocnemius on Electrical Activity of the Muscle and Dynamic Balance in Healthy Nonathelete Middle-age Men (Double Blinded Randomized Control Trial)
Public title
The Effects of Facilitatory Kinesiotaping of Gastrocnemius on Dynamic Balance in Healthy Nonathelete Middle-age Men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men
Being Healthy
Middle-age (40-65 years)
Nonathelete
Exclusion criteria:
any known musculoskeletal, cardiovascular and chronic problems require medication;
any neurological, vestibular, visual and hearing problems;
arthritis or other joint-related problems during the past 12 months;
previous allergies to adhesive tapes; previous Use of kinesiotape or knowledge about the effects it;
regular exercise activities during the six months prior to the study and during the study;
pain in lumbar and lower extremities during the selection process and inability to perform the test
Age
From 40 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
5
before kinesiotaping, immediately after, 20 minutes after, 24 hours after kinesiotaping, immediately after kinesiotaping off
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization using coin. a blind person throw the coin. if the one group samples were allocated before the other, the remaining subjects will be allocated to the second group
Blinding (investigator's opinion)
Double blinded
Blinding description
1. Participants are blind to the optimal kinesiotaping method
2. The one who put the tapes on participants' calf is blind to the study design and intervention plan
3. The outcome assessor can not see the tape in subjects' calf since every subject will wear a calf cover
4. the analyzer knows the study groups as 1 and 2 and has no clue that which group is the true kinesiotaping group
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences, Ethics Committee
Street address
Hezar Jarib Aven. Isfahan University of Medical Sciences, Faculty of Rehabilitation Sciences
City
Isfahan
Province
Isfehan
Postal code
81745-164
Approval date
2017-02-05, 1395/11/17
Ethics committee reference number
IR.MUI.REC.1395.3.814
Health conditions studied
1
Description of health condition studied
electromyography
ICD-10 code
ICD-10 code description
2
Description of health condition studied
balance
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Electerical Muscle Activity
Timepoint
Before, Immediately, 20 Minutes and 24 Hours after Kinesiotaping, Immediately after tape removal
Method of measurement
Surface Electeromyography
2
Description
Dynamic Balance
Timepoint
Before, Immediately, 20 Minutes and 24 Hours after Kinesiotaping, Immediately after tape remova
Method of measurement
strip meter
Secondary outcomes
empty
Intervention groups
1
Description
Control (Sham) Group: this group will have sham kinesiotaping on origin and insertion of Gastrocnemius muscle of the dominant leg just as the anchor and end section of KT in intervention group. Sham KT will be from the same KT brand and will be applied b
Category
Rehabilitation
2
Description
Intervention Group: this group will have facilitatory kinesiotaping from origin to insertion of Gastrocnemius muscle of the dominant leg. the subject lies in prone, the ''I'' strap proposed by kase et al with no tension on the anchor, by 15-35% stretch in
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Electrophysiology Research Center
Full name of responsible person
Dr. Zahra Sadat Rezaeian
Street address
Hezar Jarib Aven. Isfahan University of Medical sciences, Faculty of Rehabilitation Sciences