Protocol summary

Study aim
to investigate the effect of external ankle supports (i.e. ankle support orthosis, Kinesiotape) in subjects with chronic ankle instability.
Design
Parallel group, Randomized controlled trial with outcome assessor blinded
Settings and conduct
All the assessments, interventions, and data collection steps will be carried out at the School of sport sciences and health, Shahid Beheshti University. The outcome assessor and statistician will be blinded.
Participants/Inclusion and exclusion criteria
aged 18 - 40. at least one significant ankle sprain at least 12 months ago that resulted in pain, swelling, and physical activity restriction for at least 1 day. have not sprained their ankle within the six weeks prior to study onset. feeling of instability, at least two episodes of giving way in the past 6 months. Ankle instability Instrument: answer "yes" to at least 5 yes/no questions (This should include question 1, plus 4 others) Cumberland Ankle Instability Tool. Score of =<24. 20 min or greater of moderate physical activity level at least 3 days. having no mechanical instability
Intervention groups
Three groups: ankle support orthosis group, Kinesiotape group, control group
Main outcome variables
Force sense Force steadiness

General information

Reason for update
Acronym
CAI
IRCT registration information
IRCT registration number: IRCT20200315046784N3
Registration date: 2023-11-28, 1402/09/07
Registration timing: prospective

Last update: 2023-11-28, 1402/09/07
Update count: 0
Registration date
2023-11-28, 1402/09/07
Registrant information
Name
Fatemeh Azadinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
azadinia.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-11, 1402/09/20
Expected recruitment end date
2024-07-02, 1403/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ankle support orthosis and kinesiotape on force control, muscle strength, and kinesiphobia in subjects with chronic ankle instability: A randomized controlled trial
Public title
Effect of external ankle support in patients with chronic ankle instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aged 18 - 40. at least one significant ankle sprain at least 12 months ago that resulted in pain, swelling, and physical activity restriction for at least 1 day. have not sprained their ankle within the six weeks prior to study onset. feeling of instability, at least two episodes of giving way in the past 6 months. Ankle instability Instrument: answer "yes" to at least 5 yes/no questions (This should include question 1, plus 4 others) Cumberland Ankle Instability Tool. Score of =<24. 20 min or greater of moderate physical activity level at least 3 days. having no mechanical instability.
Exclusion criteria:
History of lower extremity injury, fracture, surgery or acute trauma in either lower extremity in the previous 3 months, or time since the last sprain of less than 3 months. diabetes, neuropathies, neurological pathology. consumption of muscle relaxant during research period. not receiving of ankle orthosis, kinesiotape, and physical therapy over the last 6 months. leg length discrepancies. rheumatoid arthritis. congenital deformities.
Age
From 18 years old to 40 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
The group allocation will be performed through permuted block randomization at an assignment ratio of 1:1:1. For allocation concealment, the randomization codes will be kept in opaque, sealed, sequentially numbered envelopes. Sample size is estimated at 51, however, to take account of potential withdrawals, 60 patients (n=20 per group) will be recruited for the study. First, create and seal 20 treatment A envelopes, 20 treatment B envelopes, and 20 treatment C envelopes. To create a block of 6, we will select 2 treatment A envelopes, 2 treatment B envelopes, and 2 treatment C envelopes. W will shuffle these 6 envelopes thoroughly, and place this block of 6 in a separate pile. Then, we will prepare additional blocks of 6 until all 20 treatment A, B, and C envelopes have been used. All additional blocks will be placed in their own individual piles. We will have 10 individuals piles of shuffled blocks of 6.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor will be blinded to group allocation, because all dependent variables will be measured without the orthosis and or kinesiotape, and the patients will remove their orthosis / kinesiotape before referring for post-intervention assessment. Furthermore, all data will be encoded to prevent bias and to blind the statistician.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-07-31, 1402/05/09
Ethics committee reference number
IR.IUMS.REC.1402.376

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
Force sense
Timepoint
before and after 4 weeks
Method of measurement
Isokinetic Dynamometer

2

Description
Force steadiness
Timepoint
before and after 4 weeks
Method of measurement
Isokinetic Dynamometer

Secondary outcomes

1

Description
evertor muscles strength eccentric and concentric contractions
Timepoint
before and after 4 weeks
Method of measurement
Isokinetic dynamometer

2

Description
Kinesiophobia/ fear of movement
Timepoint
before and after 4 weeks
Method of measurement
Tampa scale of kinesiphobia

Intervention groups

1

Description
Intervention group: Group A will be received an ankle support orthosis. The patients will be asked to wear the orthosis for 4 weeks.
Category
Treatment - Devices

2

Description
Intervention group: Group B: kinesiotape will be re-applied every 3 days, for 4 weeks.
Category
Treatment - Devices

3

Description
Control group: no-intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
School of sport sciences and health, Shahid Beheshti University
Full name of responsible person
Fatemeh Azadinia
Street address
Daneshjou Boulevard, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2222 8051
Email
azadinia.fatemeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza Falak
Street address
Hemat highway, next to Milad tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Azadinia
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and prosthetics
Street address
Shahnazari st., Mother Sq., Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
azadinia.fatemeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Azadinia
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and Prosthetics
Street address
Shahnazari st., Mother Sq., Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 918 130 9366
Email
azadinia.fatemeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Aadinia
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and Prosthetics
Street address
Shahnazari st., Mother Sq., Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
azadinia.fatemeh@yahoo.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Our research findings will be shared with all researchers, and practitioners. We will publish our research findings in scientific journals
When the data will become available and for how long
All documents can be shared 1 year after article publication
To whom data/document is available
Researchers and health practitioners
Under which criteria data/document could be used
Use of data is only possible by mentioning the name and organizational affiliation of the correspond and co-author of the project and the published article.
From where data/document is obtainable
Fatemeh azadinia
What processes are involved for a request to access data/document
Send email to corresponding author.
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