Protocol summary

Summary
The objective of this randomized clinical trial is to evaluate the effects of kinesio taping on ankle joint position sense of healthy untrained female during menstruation. In this study 40 healthy women with a regular menstrual cycle in past 3 months and normal bleeding cycle (4 up to 7 days) will be recruited and randomly assigned into intervention or control group. The subjects in the intervention group will receive one session of kinesiotaping of ankle joint. The subjects in control group will receive no intervention. Mean of standard error of ankle joint reconstruction angle will be measured before the intervention, immediately after and after 48 hours , and will be compared between 2 groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201605184203N12
Registration date: 2016-09-04, 1395/06/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Atefeh Aminian Far
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
aminianfar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2016-06-20, 1395/03/31
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of kinesiotaping on ankle proprioception in healthy untrained female during menstruation
Public title
Kinesiotape and ankle properioception in menstrual cycle
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: having regular menstrual cycles in the past 3 months; a natural cycle bleeding (4 up to 7 days). Exclusion criteria: missed menstrual cycle in the last 6 months, participating in regular exercise in the last 3 months; neuromuscular diseases; musculoskeletal or rheumatoid disease; vestibular system problems; history of injury and trauma to the lower extremities in the last 3 months; history of surgery in lower extremities; prior use of oral contraceptives and steroids in the last 6 months; breastfeeding; regular use of foot strap.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sealed envelope method of randomization.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Bassij Blvd, Semnan University of Medical Sciences, Deputy of Research, Semnan, Iran.
City
Semnan
Postal code
Approval date
2016-05-25, 1395/03/05
Ethics committee reference number
ir.semums.rec.1395.32

Health conditions studied

1

Description of health condition studied
Menstrula cycle
ICD-10 code
N92.0
ICD-10 code description
Excessive and frequent menstruation with regular cycle

Primary outcomes

1

Description
Standard error of ankle joint reconstruction angle
Timepoint
befor intervention, Immediately after intervention, 48 hours after intervention
Method of measurement
Biodex system

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Applying of kinesiotaping of ankle joint for 48 hours, continuously.
Category
Rehabilitation

2

Description
Control group: No intervention
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences.
Full name of responsible person
Dr Atefeh Aminian Fr
Street address
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr, Ali Rashidipour
Street address
Bassij Blvd, Semnan University of Medical Sciences, Deputy of Research, Semnan, Iran.
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research, Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences, Semnan, Iran.
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
aminfar@semums.ac.iraminfar83@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences, Semnan, Iran.
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
aminfar@semums.ac.iraminfar83@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences, Semnan, Iran.
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
aminfar@sem-ums.ac.iraminfar83@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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