Investigating the long term effects of ABT procedure on balance and functional status of a patient who suffer from chronic ankle instability
Design
Randomized Clinical trial with stratified randomization, Including two parallel interventional groups, Double blind
Settings and conduct
After screening CAI patients referred to medical centers affiliated to Shiraz University of Medical Sciences and obtaining informed consent, patients would be evaluated and then randomly assigned to two treatment groups and it will be done in the Faculty of Rehabilitation Sciences of Shiraz University of Medical Sciences. The evaluations will be repeated after the end of the treatment. Assessors will not know how patients are assigned to groups
Participants/Inclusion and exclusion criteria
Inclusion criteria:
History of sever ankle sprain at least once؛ History of emptying and twisting again and feeling of instability in the injured ankle؛ CAIT score equal to or less than 24؛ Daily activity scale equal to or less than 90% according to FAAM questionnaire؛ Exercise activity scale equal to or less than 80% according to FAAM questionnaire
Exclusion criteria: History of musculoskeletal surgery in each lower limb؛ History of lower limb fractures which need realignment؛ Acute musculoskeletal injury of other lower limb joints in last three month which affect joint stability and function ؛ History of neurological disease and ocular and vestibular disorder or any event that is effective on balance ؛ Sensitivity symptoms which are related to taping like skin redness؛ Pregnancy؛ Professional athlete
Intervention groups
We have three groups include kinsiotape group and sham group and control group. in first group we apply ABT for 4 weeks on every other day and in second group we apply tapes but without stretch and we have no intervene in third group
Main outcome variables
Static balance and dynamic balance and function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200909048671N1
Registration date:2020-10-26, 1399/08/05
Registration timing:prospective
Last update:2020-10-26, 1399/08/05
Update count:0
Registration date
2020-10-26, 1399/08/05
Registrant information
Name
Moslem Yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 2079
Email address
moslemyousefi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of long term effect of Ankle Balance Taping method on balance and function of patients with chronic ankle instability
Public title
Investigation of effect of Ankle Balance Taping on chronic ankle instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A history of at least one significant ankle sprain: The initial sprain must have occurred at least 12 months prior to the study enrolment
A history of the previously injured ankle joint ‘giving way’,and/or recurrent sprain and/or ‘feelings of instability’: participants should report at least 2 episodes of‘giving way’ in the 6 months prior to the study enrolment.
Cumberland Ankle Instability Tool (CAIT): score of equal or less than 24
Foot and Ankle Ability Measure (FAAM): ADL scale<90%; Sport scale <80%
Exclusion criteria:
A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures and nerves) in either lower extremity
A 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 (ie, sprains, fractures)resulting in at least 1 interrupted day of desired physical activity
No history of neurological disease, vestibular or visual disturbance, or any other pathology that have negative effect on balance
Taping side effects such as skin redness
Being professional athlete
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Patients after compliance with inclusion and exclusion criteria and after signing the consent form ؛ they consciously enter the study and they divided into three groups ؛ In order to randomly assign individuals to three groups the permutation block randomized method will be used hexagonal blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor is not aware of the interventions performed on patients also, the data analyzer does not know about the intervention groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee on Ethics in Biomedical Research
Street address
Sheikh Abivardi 1, Chamran Blvd., Shiraz
City
shiraz
Province
Fars
Postal code
33669-71947
Approval date
2020-05-20, 1399/02/31
Ethics committee reference number
IR.SUMS.REHAB.REC.1399.016
Health conditions studied
1
Description of health condition studied
Chronic Ankle Instability
ICD-10 code
S93.4
ICD-10 code description
Sprain of ankle
Primary outcomes
1
Description
Dynamic balance
Timepoint
Initiation of treatment, immediately after and one month after the end of the intervention
Method of measurement
Modified star excursion balance test(mSEBT)
2
Description
Static balance
Timepoint
Initiation of treatment, immediately after and one month after the end of the intervention
Method of measurement
Single leg stance
3
Description
Function
Timepoint
Initiation of treatment, immediately after and one month after the end of the intervention
Method of measurement
Single leg hop
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Kinesio type group: People in this group are treated with Ankle Balance Taping for four weeks at intervals of one day. Sham Group: This intervention is inductive. In this method, we use tape without applying tension to the person.Control group: This group of patients do not receive any treatment and are evaluated only like other groups before, immediately after and one month after the treatment interventions of other groups.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
medical centers affiliated to shiraz university of medical sciences
Full name of responsible person
samane ebrahimi
Street address
Abiverdi 1 Street, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3626 1081
Fax
+98 71 3627 2495
Email
EbrahimiS@Sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaianzadeh
Street address
Deputy of Research and Technology, 7th Floor, Central Building of Shiraz University of Medical Sciences, Zand St.
City
shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
rezaiana@sums.ac.ir
Grant name
Vice chancellor of research of Shiraz University of Medical Sciences
Grant code / Reference number
99-01-06-22602
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
Moslem Yousefi
Position
Bachelor student in Physical Therapy
Latest degree
A Level or less
Other areas of specialty/work
Physiotherapy
Street address
Second unit,Fadak Building,Alley7,Shahid moradi street,South saffir Blvd,Shiraz Town
City
shiraz
Province
Fars
Postal code
7178897667
Phone
+98 71 3727 8731
Email
moslemyousefi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Moslem Yousefi
Position
Bachelor student in Physical Therapy
Latest degree
A Level or less
Other areas of specialty/work
Physiotherapy
Street address
Second unit,Fadak Building,Alley7,Shahid moradi street,South saffir Blvd,Shiraz Town
City
shiraz
Province
Fars
Postal code
7178897667
Phone
+98 71 3727 8731
Email
moslemyousefi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Moslem Yousefi
Position
Bachelor student in Physical Therapy
Latest degree
A Level or less
Other areas of specialty/work
Physiotherapy
Street address
Second unit,Fadak Building,Alley7,Shahid moradi street,South saffir Blvd,Shiraz Town
City
shiraz
Province
Fars
Postal code
7178897667
Phone
+98 71 3727 8731
Email
moslemyousefi@yahoo.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
Not applicable
Title and more details about the data/document
All data except personal information would be available.
When the data will become available and for how long
The start of the access period is 6 months after the acceptance of the article.
To whom data/document is available
In addition to the principal researcher and the supervisor of the project, upon request, access to information can be reviewed by the Ethics Committee.
Under which criteria data/document could be used
Researchers can use data for advanced analyses or for meta analysis studies.
From where data/document is obtainable
Dr. Samaneh Ebrahimi, Shiraz, Chamran Blv., Sheikh Abivardi 1 ave.,School of Rehabilitation Sciences, Mobile:09173070211, E-mail:EbrahimiS@Sums.ac.ir
What processes are involved for a request to access data/document
After 6 months from article acceptance, while announcing a written request to the executor of the project to receive information and a precise explanation about how to use the information, an official letter is also requested to obtain permission from the ethics committee to obtain a license, and if the ethics committee approves, emphasizing the confidentiality of the information, the requested information will be provided to the applicant.