Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000522112
Ethics application status
Approved
Date submitted
14/11/2018
Date registered
2/04/2019
Date last updated
3/11/2021
Date data sharing statement initially provided
2/04/2019
Date results information initially provided
2/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Establishing return to play criteria after acute lateral ankle sprain injuries: A Delphi approach
Scientific title
Establishing return to play criteria after acute lateral ankle sprain injuries: A Delphi approach
Secondary ID [1] 296311 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ankle sprains 310018 0
Condition category
Condition code
Musculoskeletal 308774 308774 0 0
Other muscular and skeletal disorders
Injuries and Accidents 310756 310756 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 310757 310757 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A Delphi approach will be used to establish consensus of opinion from a panel of experts on RTS criteria and the definition of successful RTS after an acute lateral ankle sprain injury. There are three planned Delphi rounds, that will be 1-2 months apart. The process for each Delphi round will involve: data collection via an online survey (using the SurveyMonkey platform), analysis of responses, and provision of feedback to panelists. The goal of the Delphi process is to achieve consensus, a priori defined as >70% agreement between panelists.

For each Delphi round, expert panelists will be sent an email invitation with a link to an anonymous online survey. The first round of the Delphi survey will include a combination of structured and open response questions informed by a review of the literature. The second and third Delphi rounds will predominantly use structured questions with Likert rating responses (“Yes”, “No” or “Unsure/I do not know”). These rounds aim to quantify findings from the previous round and form a consensus among participants.

Content analysis will be used to identify themes from open response questions. Responses will initially be read for familiarisation and then re-read for identification of themes. Once themes are identified, data will be categorised. For trustworthiness and to decrease risk of bias, this process will be undertaken independently by two researchers. Analyses will be discussed between the two researchers to achieve agreement, and any items for which agreement is not achieved will be discussed with a third party. This will culminate in a list of RTS criteria from the open responses that will be developed into structured questions for the subsequent Delphi round.

Structured questions that reach consensus (>70% of panelists agreed on the inclusion or exclusion of the RTS criteria for use in sportspersons after a lateral ankle sprain) will be removed from the survey for the following round. A participant’s opinion to include a RTS criteria is defined as selection of the “Yes” Likert option, and an opinion to exclude a RTS criteria is defined a selection of the “No” option.

Between each round, feedback on the previous round will be provided to participants via email. Data from structured questions will be presented back to participants as the percentage of panelists who selected each answer category. Data from open response questions will be summarised as new RTS criteria/themes that have come out of participant responses. A thematic summary of explanation of responses will be included after each structured question that did not reach consensus in the previous round.
Intervention code [1] 312640 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307752 0
Panelists will be asked to indicate if they feel the assessment of a certain outcome should be a criterion to support the return to sport decision after an acute lateral ankle sprain. Possible answers include 'yes', 'no' or 'unsure'. Outcome that will be asked about include: swelling, pain, range of motion, arthrokinematics, ligamentous laxity, muscle function (strength, endurance, power), proprioception, balance, kinematics, physical and sport specific activities, fitness, and patient-reported outcomes.

Achievement of agreement between panelists will be calculated for each response item and is defined as >70%,
Timepoint [1] 307752 0
After three Delphi survey rounds separated by approximately 4-6 weeks (i.e. 0 weeks, 6 weeks and 12 weeks).
Secondary outcome [1] 352785 0
Summary data of demographics of survey participants including age, sex, profession, years worked, sport employed with, and experience managing return to sport after lateral ankle sprain injuries will be assessed using a purpose-designed online survey.
Timepoint [1] 352785 0
After completion of the third Delphi round (~12 weeks).

Eligibility
Key inclusion criteria
Eligibility criteria for participants (expert panelists) are: i) health professional (e.g. physiotherapist, athletic trainer/therapist, sports medicine physician); ii) currently working with athletes competing in nationally selected representative teams or teams in Tier/Division 1 national competitions (e.g. English Premier League, NCAA Division 1, Suncorp Super Netball); iii) currently working in field or court sports in which the primary gross motor skills are running and jumping/landing or changing direction and there is a high prevalence of lateral ankle sprain injuries; iv) involved in making RTS decisions for individuals with an acute lateral ankle sprain injury; v) proficiency in the English language. The sports to be targeted for this study include: basketball, volleyball, netball, handball, korfball, soccer, rugby, American/Canadian football, Australian rules football, Gaelic football, lacrosse, field hockey, hurling, camogie, tennis, badminton and squash.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from this study if they are not proficient in the English language. Individuals who are solely working with Paralympic, Invictus Games or other groups of disabled athletes, or athletes from selective populations (such as military or World Maccabiah Games athletes) are not eligible for inclusion.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/11/2018
Date of last participant enrolment
Anticipated
Actual
15/03/2019
Date of last data collection
Anticipated
15/07/2019
Actual
26/02/2020
Sample size
Target
180
Accrual to date
Final
155
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 20915 0
New Zealand
State/province [1] 20915 0
Country [2] 20916 0
Brazil
State/province [2] 20916 0
Country [3] 20917 0
Canada
State/province [3] 20917 0
Country [4] 20918 0
China
State/province [4] 20918 0
Country [5] 20919 0
France
State/province [5] 20919 0
Country [6] 20920 0
Belgium
State/province [6] 20920 0
Country [7] 20921 0
United States of America
State/province [7] 20921 0
Country [8] 20922 0
United Kingdom
State/province [8] 20922 0
Country [9] 20923 0
Ireland
State/province [9] 20923 0
Country [10] 20924 0
Netherlands
State/province [10] 20924 0
Country [11] 20925 0
Denmark
State/province [11] 20925 0
Country [12] 20926 0
Norway
State/province [12] 20926 0
Country [13] 20927 0
Japan
State/province [13] 20927 0
Country [14] 20928 0
Korea, Republic Of
State/province [14] 20928 0
Country [15] 20929 0
Italy
State/province [15] 20929 0
Country [16] 20930 0
Switzerland
State/province [16] 20930 0
Country [17] 20931 0
Qatar
State/province [17] 20931 0

Funding & Sponsors
Funding source category [1] 300907 0
University
Name [1] 300907 0
The University of Queensland
Country [1] 300907 0
Australia
Primary sponsor type
Individual
Name
Dr Michelle Smith
Address
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD 4072
Australia
Country
Australia
Secondary sponsor category [1] 300472 0
None
Name [1] 300472 0
Address [1] 300472 0
Country [1] 300472 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301676 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 301676 0
The University of Queensland
St. Lucia, QLD 4072
Australia
Ethics committee country [1] 301676 0
Australia
Date submitted for ethics approval [1] 301676 0
12/07/2018
Approval date [1] 301676 0
13/08/2018
Ethics approval number [1] 301676 0
2018001434

Summary
Brief summary
Lateral ankle sprains are the most prevalent musculoskeletal injury sustained by individuals who participate in sports. They also have the highest recurrence rate of all musculoskeletal injuries; between 32% to 74% of individuals will experience a re-injury and/or report persistent injury-associated symptoms. The high prevalence (40%) of re-injury and persistent injury-associated symptoms experienced within the 1-year time period following first-time acute lateral ankle sprain injury suggests that current management practices may be insufficient. A study of US high school athletes identified that 71% to 75% of athletes return to sport (RTS) within 3 days of incurring an acute lateral ankle sprain injury, whilst 95% of athletes RTS within 10 days of injury. Based on these timeframes, it is not surprising that sensorimotor impairments associated with acute lateral ankle sprains are still present when athletes RTS. Early, and symptomatic, RTS after an acute lateral ankle sprain injury could heighten the risk of persistent injury-associated symptoms, future injury risk and the development of secondary problems, such as ankle joint osteoarthritis.

There are a number of likely reasons why sportspersons RTS early, and with impairments, after incurring an acute lateral ankle sprain injury. First, lateral ankle sprains are often assumed to be minor injuries and consequently over half of individuals do not seek formal medical treatment. Thus, in these individuals, injury-associated sensorimotor impairments are never addressed with specific targeted rehabilitation. Second, there are currently no criteria-based guidelines to guide RTS decision making for individuals with an acute lateral ankle sprain injury.

In light of the lack of evidence for RTS criteria following acute lateral ankle sprain injury, and lack of literature addressing this question, there is need to determine and collate expert opinion to inform RTS practice. The Delphi process is one method that can be used to collate and refine expert opinion. This approach has been undertaken to inform the development of RTS criteria for hamstring injuries. Information gained by this process can be used to inform the development of RTS criteria for acute lateral ankle sprains and provide the basis for prospective cohort studies to test the use of the proposed criteria for successful RTS.

The aim of this study is to use a Delphi approach to develop consensus for RTS criteria for individuals who have sustained an acute lateral ankle sprain injury.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87750 0
Dr Michelle Smith
Address 87750 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD 4072
Country 87750 0
Australia
Phone 87750 0
+61 7 3365 4660
Fax 87750 0
Email 87750 0
[email protected]
Contact person for public queries
Name 87751 0
Dr Michelle Smith
Address 87751 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD 4072
Country 87751 0
Australia
Phone 87751 0
+61 7 3365 4660
Fax 87751 0
Email 87751 0
[email protected]
Contact person for scientific queries
Name 87752 0
Dr Michelle Smith
Address 87752 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD 4072
Country 87752 0
Australia
Phone 87752 0
+61 7 3365 4660
Fax 87752 0
Email 87752 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual survey data will be used to develop consensus for RTS criteria. Data will be presented as achievement of consensus (yes/no) and level (%) of agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12561Ethical approval    376173-(Uploaded-04-03-2021-10-45-58)-Study-related document.pdf
12562Study protocol    376173-(Uploaded-04-03-2021-12-40-28)-Study-related document.pdf
12563Informed consent form    376173-(Uploaded-04-03-2021-12-45-02)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Smith MD, Vicenzino B, Bahr R, Bandholm T, Cooke R... [More Details]

Documents added automatically
No additional documents have been identified.