Study of the effects of cognitive changes associated with sensory taping on the center of pressure displacement in the athletes with chronic ankle sprain
Design
A controlled clinical trial study with parallel group design
Settings and conduct
This study will be carried out at the Neuromuscular Rehabilitation Center of Semnan University of Medical Sciences. In this study, patients will be evaluated for pain and balance after entering the study and filling out the consent form. Then, related area of the affected leg will be taped from origin to insertion of the peroneal muscles, and immediately after the tape, the balance of the subjects will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with chronic ankle sprain for the last two years in the age range of 18-40 years
Exclusion criteria: Any disorders in balance and other musculoskeletal disorders, fractures and bone defects of the lower limbs and trunk
Intervention groups
Experimental group: In this group, the patients will be intervened via the ankle taping.
Control group: In this group, healthy people without any disease will be studied according to the study parameters.
Main outcome variables
Pain, center of pressure parameters.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029264N6
Registration date:2019-07-09, 1398/04/18
Registration timing:prospective
Last update:2019-07-09, 1398/04/18
Update count:0
Registration date
2019-07-09, 1398/04/18
Registrant information
Name
Rasool Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
rasool.bagheri@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cognitive changes associated with sensory taping on balance in athletes with ankle sprain
Public title
Efficacy of taping on chronic ankle sprain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of ankle sprain in past two years
Having a history of at least two giving way in the ankle joint
Negative anterior drawer test
Exclusion criteria:
Presence of a disturbance in standing and balance.
Memory impairment
History of fracture in the lower extremities
Neural defects such as Parkinson's disease, neuropathy, diabetes, anemia and middle ear disorder, musculoskeletal disorders in the limbs and trunk
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, a researcher who will evaluate the outcomes and results will not be informed about the allocation of groups.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, patients group will be compared with a healthy group according to the balance parameters. After the intervention in the patient group, the balance parameters will be compared between the two groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comitee of Semnan University of Medical Sciences
Street address
Basij Blvd.,Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
3513135111
Approval date
2019-06-11, 1398/03/21
Ethics committee reference number
IR.SEMUMS.REC.1398.057
Health conditions studied
1
Description of health condition studied
Chronic ankle sprain
ICD-10 code
S93.4
ICD-10 code description
Sprain of ankle
Primary outcomes
1
Description
pain
Timepoint
Before and after taping of ankle
Method of measurement
A 100 mm visual analogue pain scale
Secondary outcomes
1
Description
Static balance
Timepoint
Before and after ankle taping
Method of measurement
Mean of center of pressure displacement
Intervention groups
1
Description
Intervention group: In this group, the patient will be treated with Kinesio-tape in 1 session. One piece of Kinesio-tape is prepared about 80% of the calf and after the skin is prepared, the brigade is attached to the outer region of the leg and from the beginning to the ends of the peroneal muscles. Balancing measurements will be made immediately after typing.
Category
Rehabilitation
2
Description
Control group: In this group, without any interventions, balance measurements will be made as in the intervention group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center,. Semnan University of Medical Scinces., Semnan., Iran.
Full name of responsible person
Dr Rasool Bagheri
Street address
Basij Blvd.,Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3336 4180
Email
rasool.bagheri@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Parviz Kokhaei, Deputy of Research and Technology University
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3336 4180
Email
rasool.bagheri@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Javan
Position
Master Science Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
B
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3336 4180
Email
rasool.bagheri@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Rasool Bagheri
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Basij Blvd, Semnan, Semnan Province.
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3336 4180
Email
rasool.bagheri@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Rasool Bagheri
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Basij Blvd.,Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3336 4180
Email
rasool.bagheri@ymail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available