Evaluation of effect of fibular repositioning taping technique on balance in patients with chronic ankle instability
Design
a concealed, randomized, single blinded clinical trial including 3 groups (amongst Sham and control groups) with a parallel group design.
Settings and conduct
Therapeutic groups are treated for two weeks, three times a week. Assessments are performed once before the onset and once after the completion of treatment sessions in all three groups. the evaluator does not have any information on the patients grouping . All stages of assessment and treatment will be carried out at the clinic of the Faculty of Rehabilitation Sciences of Shiraz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Participants: male and female with chronic ankle instability
inclusion criteria:The history of at least one significant ankle sprai, Reporting the previous ankle injury, ankle giving way, recurrent ankle sprain, feeling of instability in the ankle joint, a score of less than 90% in the daily activities section and a score of less than 80% in the sports activities section of the FAAM questionnaire and also a score of less than 24 from the CAIT questionnaire.
; Non-entry criteria: Surgical history of musculoskeletal structure in both lower limbs, the history of fracture in each of the lower limbs that needs to be reconstructed, acute injury to musculoskeletal structures of the other lower limb joints over the past 3 months, which has impaired individual function.
Intervention groups
The subjects are divided into three groups:1) fibular repositioning tape, 2)the sham taping (taping without applying stretch), 3) control group.
Main outcome variables
static balance, dynamic balance, function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171122037576N2
Registration date:2018-05-24, 1397/03/03
Registration timing:prospective
Last update:2018-05-24, 1397/03/03
Update count:0
Registration date
2018-05-24, 1397/03/03
Registrant information
Name
Mohammad Hadadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
hadadim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of fibular repositioning taping technique on balance in patients with chronic ankle instability
Public title
Evaluation of effect of taping on balance in patients with chronic ankle instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The history of at least one significant ankle sprain-The primary ankle sprain should have occurred at least 12 months before the study, accompanied by inflammatory symptoms (pain, swelling, etc.) and caused at least one day interruption in the physical activity of the individual-The last sprain should have occured three months before the study.
Reporting the previous ankle injury, ankle giving way (at least 2 cases in 6 months before the study), recurrent ankle sprain (2 cases of sprain or more) and feeling of instability in the ankle joint
In the assessments done: - A score of less than 90% in the daily activities section and a score of less than 80% in the sports activities section of the Foot and Ankle Ability Measure (FAAM) questionnaire.- A score of less than 24 from the Cumberland Ankle Instability Tool (CAIT) questionnaire.
Exclusion criteria:
Surgical history of musculoskeletal structure in both lower limbs.
The history of fracture in each of the lower limbs that needs to be reconstructed
Acute injury to musculoskeletal structures of the other lower limb joints over the past 3 months, which has impaired individual function.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization is used to randomize the allocation of individuals to groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be evaluated by someone other than the therapist and the evaluator does not have any information on patients grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical sciences ethics committee
Street address
School of Rehabilitation- Abiverdi1- Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71345-1733
Approval date
2018-05-09, 1397/02/19
Ethics committee reference number
IR.SUMS.REC.1397.142
Health conditions studied
1
Description of health condition studied
Chronic Ankle Instability
ICD-10 code
M25.37
ICD-10 code description
Other instability, ankle and foot
Primary outcomes
1
Description
Assessment the: dynamic balance with modified star excursion balance test, Static balance with single leg stance test, function with single leg hop test
Timepoint
before the onset and after the completion of therapeutic sessions.
Method of measurement
modified star excursion balance test, single leg stance test, single leg hop test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: fibular repositioning taping
Category
Treatment - Devices
2
Description
Intervention group: Sham taping
Category
Placebo
3
Description
Control group: receive no treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hadadi
Street address
School of Rehabilitation- Abiverdi1- Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
hadadim@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hadadi
Street address
School of Rehabilitation- Abiverdi1- Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
hadadim@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
Mohammad Hadadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
School of Rehabilitation- Abiverdi1- Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
hadadim@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hadadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
School of Rehabilitation- Abiverdi1- Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
hadadim@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hadadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
School of Rehabilitation- Abiverdi1- Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
hadadim@sums.ac.ir
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