Investigation of the combined effect of fibular reposition taping and facilitatory fibularis longus taping on balance of patient with chronic ankle instability
Determine the combined effect of fibular reposition taping and facilitatory fibularis longus taping on balance of patient with chronic ankle instability
Design
Two arm parallel group randomized trial with blinded randomization according to random allocation
Settings and conduct
Study place: Shiraz University of Medical Sciences. Design: two tailed blinded; evaluation before and after taping
Participants/Inclusion and exclusion criteria
Inclusion criteria: history of at least one significant ankle sprain; the initial sprain must have occurred at least 12 months
prior to the study enrollment; the most recent injury must have occurred more than 3 months prior to the study enrollment.
Exclusion criteria: history of the ‘giving way’ and/or recurrent sprain and/or ‘feelings of instability’.
A general self-reported foot and ankle function questionnaire
is recommended to describe the level of disability
exclucion:
A history of previous surgeries
A history of a fracture
Acute injury to the musculoskeletal structures of other joints
of the lower extremity in the previous 3 months,
sympthom of neurologic impairments
non treated sprains
spine disease
sensitivity of skin to tape
Intervention groups
Placebo taping; treatment: combined of facilitatory fibularis longus and fibular reposition taping
Main outcome variables
Balance; postural control; limit of stability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180820040841N1
Registration date:2019-03-18, 1397/12/27
Registration timing:prospective
Last update:2019-03-18, 1397/12/27
Update count:0
Registration date
2019-03-18, 1397/12/27
Registrant information
Name
َAmir Nejati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 5829 1673
Email address
nejati_a@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the combined effect of fibular reposition taping and facilitatory fibularis longus taping on balance of patient with chronic ankle instability
Public title
Investigation of the combined effect of fibular reposition taping and facilitatory fibularis longus taping on balance of patient with chronic ankle instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least have one sprain
First sprain occur 12 month before study
At least 3 month spent from last sprain
Have a history of giving way or recurrent sprain or have a feeling of instability.in this study will use of Cumberland Ankle Instability Instrument.
Foot and ankle ability measure for determine level of instability
Exclusion criteria:
History of previous surgeries to the musculoskeletal structures
History of a fracture in either lower extremity requiring realignment.
Acute injury to the musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function
Abnormal neurological signs
Severe non treated sprains
Disease of spines
Severe skin sensitivity
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
By random allocation software
Blinding (investigator's opinion)
Double blinded
Blinding description
this is a two tail blind study and in this study patient and investigators are blind to intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
1433671348
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.SUMS.REHAB.REC.1397.011
Health conditions studied
1
Description of health condition studied
Chronic ankle instability
ICD-10 code
S93.4
ICD-10 code description
Sprain and strain of ankle
Primary outcomes
1
Description
Postural control
Timepoint
Before taping, imediately after taping and 48 hours after taping
Method of measurement
Biodex balance SD
2
Description
Limit of stability
Timepoint
Before taping, imediately after taping and 48 hours after taping
Method of measurement
Biodex balance SD
Secondary outcomes
1
Description
Joint position sense
Timepoint
Before taping, imediately after taping and 48 hours after taping
Method of measurement
Multi joint system
Intervention groups
1
Description
Intervention group: combined of fibular reposition taping and facilitatory fibularis longus taping.
Category
Rehabilitation
2
Description
Control group: placebo tape is apply on tibia without any tension.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Amir Nejati
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1551
Email
nejati_a@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yones Ghasemi
Street address
Shiraz University of Medical Sciences, Zand street
City
shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Amir Nejati
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1552
Email
nejati_a@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Nejati
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1552
Email
nejati_a@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Nejati
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1552
Email
nejati_a@sums.ac.ir
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
IPD and method of study and report of study and cosent form will be publish after the article was be published.
When the data will become available and for how long
After publication of the article
To whom data/document is available
Specialized people
Under which criteria data/document could be used
Conditions depend on journal
From where data/document is obtainable
Library of Shiraz University of Medical Sciences and the journal that article published in that
What processes are involved for a request to access data/document
After sending email to me and depend on the Journal condition