Evaluation and comparison of Chronic ankle instability patient with using Star Excursion Balance Test, Single Leg Stance Test, Single Leg Hop Test before and after treatment
Design
In this study, 60 subjects with Chronic ankle instability were selected by convenience sampling method and randomly divided into 4 groups.
Settings and conduct
Individuals in each group are evaluated once before starting the study and once after completion of the treatment using balance tests.The participants are evaluated by an assessor and interventions are done by another person. The participants are evaluated at the Faculty of Rehabilitation Sciences Clinic
Participants/Inclusion and 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
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
Intervention groups
participants was divided in 4 group
first group received soft orthosis
second group received semi-rigid orthosis
third group received KinesioTape
fourth group received no intervention
Main outcome variables
static balance;
dynamic balance;
function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171122037576N3
Registration date:2018-07-03, 1397/04/12
Registration timing:prospective
Last update:2018-07-03, 1397/04/12
Update count:0
Registration date
2018-07-03, 1397/04/12
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
2018-08-06, 1397/05/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of ankle kinesiotaping, soft ankle orthosis and semi-rigid ankle orthosis on balance in patients with chronic ankle instability
Public title
Evaluation of effect of orthoses on 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 jointIn 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 FAAM questionnaire
A score of less than 24 from the CAIT questionnaire.
age range of 18 to 45 years
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
Not 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.1397.150
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
Timepoint
before the onset and after the completion of therapeutic sessions
Method of measurement
modified star excursion balance test,
2
Description
Assessment the Static balance
Timepoint
before the onset and after the completion of therapeutic session
Method of measurement
single leg stance test
3
Description
Assessment the function
Timepoint
before the onset and after the completion of therapeutic session
Method of measurement
single leg hop test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: soft orthosis- a neoprene ankle support that wear for 4 weeks
Category
Treatment - Devices
2
Description
Intervention group: semi-rigid orthosis- an ankle support with thermoplastic support that wear for 4 weeks
Category
Treatment - Devices
3
Description
Intervention group: Kinesio Tape- in this group, ankle taping is done with using Kinesio Tape for 4 weeks
Category
Treatment - Devices
4
Description
Control group: 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
Vice-Chancellery for Research and Technology of Shiraz University of Medical Sciences
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
Private
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
orthotics and prosthetics
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
orthotics and prosthetics
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
Shiraz University of Medical Sciences
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
orthotics and prosthetics
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