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Trial registered on ANZCTR


Registration number
ACTRN12620000128998
Ethics application status
Approved
Date submitted
3/12/2019
Date registered
11/02/2020
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Do ankle braces affect functional performance?
Scientific title
Do ankle braces affect functional performance in people with chronic ankle instability? A double-blinded randomized control trial
Secondary ID [1] 300128 0
nil known
Universal Trial Number (UTN)
U1111-1244-8695
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute ankle sprain 315460 0
chronic ankle instability 315461 0
Condition category
Condition code
Musculoskeletal 313759 313759 0 0
Other muscular and skeletal disorders
Injuries and Accidents 313947 313947 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The KISS® ankle brace is a new device created to only restrict end of inversion range movement, (the usual ankle spraining movement). An independent person (honors or PhD student) trained to properly fit ankle braces will apply ankle braces and markers appropriately. The main investigators (honors or PhD student) will remain blinded until the trial is completed, and concealment will only be broken to primary investigator/s once measurements are recorded at the end of the trial. participants will be wearing the ankle brace during the testing session (2.5 hours) and required to complete a number of tasks including; side hop test, star excursion balance test, triple hop test, agility t test, standing vertical jump and maximum vertical jump. Follow up study will be one-week after test session were participants will be invited to take home the brace for the duration of the week during any weight-bearing activities or at their discretion to wear and will come back for a follow-up session which they will wear for another 2.5 hours. They will receive instructions on how to appropriately fit the brace. Participants will be asked to return the brace when they return for the 1-week follow-up. A Work boot sock protector will be worn over the ankle (but not restrict the brace or ankle, or the shoe/floor interface) to conceal the brace or no brace condition from the primary tester. It will also conceal the brace type from the participants.
The braces will also have the manufacturers markings removed or erased with indelible ink

There is NO washout period: participants will be tested in ALL conditions on the same day.
Intervention code [1] 316258 0
Treatment: Devices
Intervention code [2] 316259 0
Prevention
Intervention code [3] 316260 0
Rehabilitation
Comparator / control treatment
no brace - participant will not be wearing an ankle brace and will only be wearing the shoes that they have bought with them to the testing session
Control group
Active

Outcomes
Primary outcome [1] 322170 0
Side hop test - All participants will be instructed to hop on 1 limb laterally over a 30-cm distance. One repetition is hopping laterally 30 cm and back to the starting location. Each participant completes 10 repetitions as quickly as possible and time to complete will be marked in the participants booklet in seconds. Participants will have a practice trial and then will perform the test twice and the best time used in data analysis
Timepoint [1] 322170 0
at baseline and during test session (which will be during application of intervention/condition) after 3 attempts and at one-week follow up.
Primary outcome [2] 322346 0
composite participant’s perceptions of stability, reassurance and confidence following Lateral hop test will be completed prior to the first test and after the last trial, for each condition (Halim-Kertanegara et al). The 11-point numerical rating scale (NRS) will be used to measure perceived stability, reassurance and confidence in the specific task. The participant will be asked, “On a scale from 0 to 10, with 0 being no stability (/confidence/reassurance) and 10 being completely stable/confident/ reassured, how stable/confident/reassured did your ankle feel during the task?” OR ‘…do you think it will be when you perform the task?”
Timepoint [2] 322346 0
at baseline and during test session (which will be during application of intervention/condition) after 3 attempts and at one-week follow up.
Secondary outcome [1] 377563 0
Dynamic balance (Star Excursion Balance Test)




Timepoint [1] 377563 0
at baseline and during test session (which will be during application of intervention/condition) after 3 attempts and at one-week follow up.
Secondary outcome [2] 378164 0
Triple hop test - Participants will stand behind a line and hop in the forward direction 3 times on the test leg as far as possible, standing for 2 seconds between each hop. The distance hopped will be measured using a calibrated tape measure that will be placed on the ground while they attempt the hop, and the best of 2 attempts will be used in analysis (Hopper et al).
Timepoint [2] 378164 0
at baseline and during test session (which will be during application of intervention/condition) after 3 attempts and at one-week follow up.
Secondary outcome [3] 378165 0
Agility T-test - Cones are laid out in the shape of a T. The participant starts at cone A. On the command of the timer, the participant sprints to cone B and touches the base of the cone with their right hand. They then turn left and shuffle sideways to cone C, and also touch its base, this time with their left hand. Then shuffling sideways to the right to cone D and touching the base with the right hand. They then shuffle back to cone B touching with the left hand, and run backwards to cone A. The stopwatch is stopped as they pass cone A. The test will be performed once but participants will have one practice trial (Kyrytsis et al)
Timepoint [3] 378165 0
at baseline and during test session (which will be during application of intervention/condition) after 3 attempts and at one-week follow up.
Secondary outcome [4] 378166 0
Standing vertical jump - After the standing reach is measured, the participant jumps vertically as high as possible and taps the Vertec device without a running start (both feet flat on the floor). The score is the difference between the standing reach and the jump reach measured in centimetres. There will be one practice trial and 2 test jumps with the best jump used in analysis (Burkett et al).
Timepoint [4] 378166 0
at baseline and during test session (which will be during application of intervention/condition) after 3 attempts and at one-week follow up.
Secondary outcome [5] 378167 0
Maximum vertical jump - After the standing reach is measured, the participant jumps vertically as high as possible and taps the Vertec device with a running start. The participant can take any number of steps as long as the approach distance is within a 4.6 m arc and can choose either a 1-foot or 2-foot take off. The score is the difference between the standing reach and the jump reach measured in centimetres. There will be one practice trial and 2 test jumps with the best jump used in analysis (Burkett et al).
Timepoint [5] 378167 0
at baseline and during test session (which will be during application of intervention/condition) after 3 attempts and at one-week follow up.

Eligibility
Key inclusion criteria
Inclusion criteria for CAI group:
* Age 18-65 years
* History of at least one previous ankle sprain
* At least two episodes of the previously injured ankle experiencing recurrent sprains, ‘giving way’ or ‘feelings of instability’ in the past six months
* Cumberland Ankle Instability Tool (CAIT) score <=24
*Proficient in English to complete the study questionnaires and understand instructions
Inclusion criteria for control group:
* Age 18-65 years
* No previous history of ankle sprain
* Cumberland Ankle Instability Tool (CAIT) score > 28
* Proficient in English to complete the study questionnaires and understand instructions
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for both groups:
* A history of previous musculoskeletal surgery to either lower extremity
* A history of a previous lower limb fracture requiring realignment
* An acute musculoskeletal joint injury of the lower extremity in the past three months
* A vestibular disorder or neurological disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque envelopes will be used to randomize participants into the order of condition (i.e., no brace, KISS® ankle brace and standard brace).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
A Work boot sock protector will be worn over the ankle (but not restrict the brace or ankle, or the shoe/floor interface) to conceal the brace or no brace condition from the primary tester. It will also conceal the brace type from the participants.
The braces will also have the manufacturers markings removed or erased with indelible ink.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304448 0
University
Name [1] 304448 0
University of Sydney
Address [1] 304448 0
75 East St Lidcombe NSW 2141
Country [1] 304448 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
75 East St Lidcombe NSW 2141
Country
Australia
Secondary sponsor category [1] 304713 0
None
Name [1] 304713 0
Address [1] 304713 0
Country [1] 304713 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304881 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 304881 0
University of Sydney, 75 East Street Lidcombe NSW 2141
Ethics committee country [1] 304881 0
Australia
Date submitted for ethics approval [1] 304881 0
Approval date [1] 304881 0
12/11/2019
Ethics approval number [1] 304881 0
2019/944

Summary
Brief summary
Ankle braces have been proven to prevent ankle sprain, in both people who have never sprained an ankle and those who are recurrent sprainers (Doherty et al, 2017). The downside is that braces affect the mobility of the foot as they restrict all joints they pass over, and so often affect performance in activities such as walking, jumping and hopping (Doherty et al, 2017). This is of concern as braces are often applied in potential ankle spraining situations, such as sport, where performance should be optimal. To address this issue, the KISS® ankle brace was designed to allow unrestricted ankle and foot joint movement within normal ranges, whilst supporting the subtalar joint and restricting only end-range joint motion. To date, there are no studies investigating whether this claim is true. Thus, the aim of this study is to investigate whether the KISS® ankle brace maintains functional performance, immediately after application and after a period of adaption to the brace, compared with a standard brace condition. Additionally, to identify whether the KISS® ankle brace achieves the aim of being easy to apply, light weight, comfortable, and unnoticeable during activity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98518 0
Dr Claire Hiller
Address 98518 0
University of Sydney, 75 East street Lidcombe NSW 2141
Country 98518 0
Australia
Phone 98518 0
+61 2 9351 9108
Fax 98518 0
Email 98518 0
claire.hiller@sydney.edu.au
Contact person for public queries
Name 98519 0
Dr Claire Hiller
Address 98519 0
University of Sydney, 75 East street Lidcombe NSW 2141
Country 98519 0
Australia
Phone 98519 0
+61 2 9351 9108
Fax 98519 0
Email 98519 0
claire.hiller@sydney.edu.au
Contact person for scientific queries
Name 98520 0
Dr Claire Hiller
Address 98520 0
University of Sydney, 75 East street Lidcombe NSW 2141
Country 98520 0
Australia
Phone 98520 0
+61 2 9351 9108
Fax 98520 0
Email 98520 0
claire.hiller@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data collected as part of this study will be used as part of the clinical trial only
What supporting documents are/will be available?
No other documents available
Summary results
No Results