Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001392853
Ethics application status
Approved
Date submitted
12/08/2021
Date registered
15/10/2021
Date last updated
11/08/2022
Date data sharing statement initially provided
15/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes following an optimised anterior cruciate ligament (ACL) reconstruction rehabilitation program in community-level athletes
Scientific title
Feasibility and efficacy of a pragmatic anterior cruciate ligament reconstruction rehabilitation program in community-level athletes: a mixed-methods case series
Secondary ID [1] 304962 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Cruciate Ligament Injury 323107 0
Condition category
Condition code
Physical Medicine / Rehabilitation 320683 320683 0 0
Physiotherapy
Musculoskeletal 321022 321022 0 0
Other muscular and skeletal disorders
Injuries and Accidents 321023 321023 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete the intervention as part of their regular clinical care post ACL reconstruction.

The intervention will include two components: 1) physical and 2) contextual and patient-related. All interventions will be delivered at private outpatient physiotherapy clinics across the Gold Coast as part of clinical care by the lead author or a physiotherapist trained in the delivery of the intervention as determined by the lead author (experience level 1-6 years).

The delivery of the intervention will be guided by our custom ACL Rehabilitation Guide, which will be provided to the participants.

Physical intervention
The physical intervention reflects a pragmatic rehabilitation program designed to address specific deficits following ACL reconstruction based on the results of preceding research and best practice rehabilitation principles. Treatment will commence at any time prior to surgery or within 3 weeks of reconstruction, continuing for a period of 12 months post the date of surgery. The intervention consists of five phases.

1. Prehabilitation (from the first consultation to surgery, patients may not have pre-surgery consultation)– rehabilitation focuses on settling pain and swelling, restoring range of motion, and commencing resistance exercise to improve function prior to surgery. Exercises may include inner range quads, extension sag, cycling, squats, steps ups, lunges and hopping activities when deemed appropriate.

2. Early (0-6 weeks) – rehabilitation focus on settling pain and swelling, restoring range of motion, , improving balance and proprioception, normalising gait and minimising quads atrophy. Exercises may include inner range quads, extension sag, cycling, squats, steps ups when deemed appropriate.

3. Mid (6 weeks to 5 months) - rehabilitation focus on building muscle mass, improving motor control, commencing jump training, prepare to run drills, and developing aerobic fitness. Participants are encouraged to commence gym-based resistance exercise to promote appropriate strength training stimulus. Exercises may include leg press, bridging variations, squat and deadlift variations, step ups, single leg squatting, cycling, cross trainer land and pool-based running technique drills.

4. Late (5-9 months) - rehabilitation focus on developing high level strength, power, technical proficiency, and fitness to achieve symmetry between limbs. This includes strength training, jump and plyometric training, field-based rehabilitation with a focus on cutting and lateral movement in pre-planned situations before progressing to reactive situations. Exercises may include squat and deadlift variations, lunge variations, single leg squat, box and hurdle jump variations, lateral shuffle drills, cone cutting and agility drills reacting to therapist signal or other player movement.

5. Return to sport (9-12 months) - rehabilitation will continue to build on the late phase training with a particular focus on single leg strength and control and reactive change of direction. This phase also entails developing a return to sport plan for transition back into practice and then game play as appropriate. Exercises may include single leg squat, single leg deadlift, Bulgarian split squat, reactive multi-directional hopping drills, reactive agility drills and small-sided games.

The aim of the physical intervention is to expose the participant to a specific and intense training stimulus designed appropriately based on established exercise prescription principles (for example early phase daily low load exercises due to post-operative restrictions before progressing to 2-3 x week lower limb strength training at 12RM or heavier for total sets 8-10/muscle group per week int eh later phases). Exercise prescription will be adapted to the client and include exercises appropriate to the phase of rehabilitation. A physiotherapist will actively observe, correct, and progress exercises as deemed appropriate during and between sessions.

All sessions will be delivered as per the clinical judgement of the treating physiotherapist, guided by an overarching rehabilitation protocol developed specifically for this study. Time frames for each phase are provided as a guide only as participants must pass a set of progression criteria before moving to the next phase of rehabilitation. As detailed below this may involve supervised, unsupervised, group and telehealth options, with the frequency and duration of the scheduled sessions to vary depending on the needs of the participant determined through consultation between the clinician and therapist. Group sessions are only available from the mid-phase onwards.

To address the barriers identified during the initial studies regarding exercise delivery, patients will be provided with their exercise program via the online exercise prescription software "Physiotec" (https://physiotec.ca/ca/en/). The program also allows tracking of independent exercise completion. The frequency and duration of supervised and group based interventions can be monitored through the practice management software.

Contextual and patient-related intervention
The rehabilitation program will not only consider the physical components of rehabilitation but the contextual and patient-related factors. A key time point to address these factors will be at the commencement of each phase of rehabilitation. This process will involve an appointment (4-5 sessions, 30-60minutes, delivered face-face or via Zoom.) with the rehabilitation provider to develop a plan for the upcoming phase. This plan includes goal setting, discussion of service delivery, identification of barriers to rehabilitation and monitoring patient psychology. This process forms part of the five main contextual and patient-related target concepts detailed below:

1. Informational support – participants will subscribe to an email mail-out (1-2 per week, approx 2-5min reading time) detailing information relevant to the phase of rehabilitation. This provides a verified source of quality information. For example, during the recovery phase participants will receive information pertaining to managing swelling and pain post-operatively, strategies to minimise quadricep atrophy, how to regain knee extension and facilitate bending.

2. Goal setting and re-assessment – collaborative goal-setting sessions at the commencement of each phase of rehabilitation will facilitate the planning of appropriate ongoing rehabilitation.

3. Service delivery –The different modes of service delivery will be presented to participants, including supervised, unsupervised, group and telehealth options. This ensures the participants care can be optimised based on their circumstances and barriers to rehabilitation.

4. Identification of barriers to rehabilitation –the participant will be asked about and presented with a list of potential barriers to rehabilitation. Through discussion, solutions to the potential barriers will be determined and implemented to optimise rehabilitation participation for the individual.

5. Patient psychology – Participant expectations, activities they find challenging or are fearful will regularly be monitored and assessed. Rehabilitation can then be implemented to address these factors.
Intervention code [1] 321352 0
Rehabilitation
Intervention code [2] 321594 0
Treatment: Other
Intervention code [3] 321595 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328504 0
Percentage of participants meeting return to sport testing battery as defined by Edwards et al. (2018)

Edwards PK, Ebert JR, Joss B, Ackland T, Annear P, Buelow JU, et al. Patient Characteristics and Predictors of Return to Sport at 12 Months After Anterior Cruciate Ligament Reconstruction: The Importance of Patient Age and Postoperative Rehabilitation. Orthop J Sports Med. 2018;6(9):2325967118797575.
Timepoint [1] 328504 0
12 months post ACL reconstruction
Secondary outcome [1] 399216 0
Percentage of participants returned to level 1 or 2 sports.

To be evacuated using the Noyes Sports Activity rating Scale (NSARS).
Level 1 (4-7 days/week) or level 2 (1-3 days/week) activities including:
- Jumping, hard pivoting and cutting
- Running twisting and turning sports

Noyes FR, Barber SD, Mooar LA. A rationale for assessing sports activity levels and limitations in knee disorders. Clin Orthop Relat Res. 1989 Sep;(246):238-49. PMID: 2670388.
Timepoint [1] 399216 0
12 months post ACL reconstruction
Secondary outcome [2] 400472 0
Qualitative thematic analysis of patients' experience of rehabilitation. Data will be generated through the conduct of individual participant audio-recorded interviews estimated to last no longer than 30 minutes. utilising a semi-structured interview guide. All participants will be approached to participate in the focus groups.
Timepoint [2] 400472 0
Between 12-18 months post ACL reconstruction
Secondary outcome [3] 412781 0
Percentage of participants completing rehabilitation as defined by Edwards et al. (2018).

To be evaluated at 12 months assessment utilising the 7-point categorical rehabilitation grading tool developed by Edwards et al. (2018).

Edwards PK, Ebert JR, Joss B, Ackland T, Annear P, Buelow JU, et al. Patient Characteristics and Predictors of Return to Sport at 12 Months After Anterior Cruciate Ligament Reconstruction: The Importance of Patient Age and Postoperative Rehabilitation. Orthop J Sports Med. 2018;6(9):2325967118797575.
Timepoint [3] 412781 0
12 months post ACL reconstruction

Eligibility
Key inclusion criteria
1. Noyes Sports Activity rating Scale (NSARS) level 1 (4-7 days/week) or level 2 (1-3 days/week) activities including:
o Jumping, hard pivoting and cutting (e.g. basketball, netball, football, soccer, rugby,
gymnastics, handball, oztag, touch football, AFL, American football, Gaelic football)
o Running twisting and turning sports (e.g. racket sports, tennis, squash, surfing, baseball,
hockey, skiing, skateboarding, snowboarding, wrestling, boxing, martial arts, ice hockey,
field hockey, dancing, baseball)
2. ACLR, with graft selected at surgeon’s preference
3. Initial consultation prior to or within three weeks of ACLR
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior surgery to the injured or contralateral limb
2. Aged < 18 years old
3. Weight-bearing restrictions post-surgery due to concomitant injuries
4. Range of motion restrictions post-surgery due to concomitant injuries
5. Not planning to return to aforementioned NSARS levels

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size
The researchers aim to recruit approximately 15 participants to complete the 12-month intervention and subsequent return to sport testing session.

Following completion of rehabilitation participants will be asked to participate in individual interviews to investigate their experience of rehabilitation. All participants involved in the intervention will be approached for participation.

Statistical analysis
Statistical analyses will be performed using SPSS (Version 22). Descriptive analyses will be performed for demographic variables. Data will be presented as means with standard deviations or medians with interquartile range (IQR) for continuous variables and with frequency and percentages for categorical variables.

Duration of supervised rehabilitation, frequency of appointments, demographics and physical measures will be investigated as factors of influence in the achievement of the primary outcomes. The relationship between categorical variables may be explored using the Chi-Square statistic. Relationships between continuous variables will be explored using a series of univariant linear or logistic regression. Significance will be set at p<0.05, and effect sizes for appropriate variables will be established and classified as small (0-0.29), medium (0.3-0.49), or large >0.5).

Data will be recorded in an excel spreadsheet and exported to SPSS Version 26 following the intervention. This will permit data to be analysed and tabulated.

The participant interview data will be evaluated, utilising a direct thematic analysis method. The audio recording of the focus group(s) will be transcribed verbatim. The data will then be coded using the qualitative data analysis software NVivo Version 12 (QSR International Pty. Ltd). The analysis begins with the research team independently coding the data. They will work to identify higher-order themes and sub-themes. The researchers will repeatedly meet to reflect and discuss the data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
1/11/2021
Date of last participant enrolment
Anticipated
8/09/2022
Actual
16/03/2022
Date of last data collection
Anticipated
8/09/2023
Actual
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 309349 0
University
Name [1] 309349 0
Bond University
Country [1] 309349 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Dr, Robina QLD 4226
Country
Australia
Secondary sponsor category [1] 310316 0
None
Name [1] 310316 0
None
Address [1] 310316 0
None
Country [1] 310316 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309166 0
Bond University Human Reseach Ethics Committee
Ethics committee address [1] 309166 0
Ethics committee country [1] 309166 0
Australia
Date submitted for ethics approval [1] 309166 0
12/05/2021
Approval date [1] 309166 0
13/08/2021
Ethics approval number [1] 309166 0
AW02899

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113210 0
Mr Adam Walker
Address 113210 0
Bond University Institute of Health and Sport
School of Physiotherapy
2 Promethean Way, Robina, QLD, 4226
Country 113210 0
Australia
Phone 113210 0
+61408051943
Fax 113210 0
Email 113210 0
[email protected]
Contact person for public queries
Name 113211 0
Adam Walker
Address 113211 0
Bond University Institute of Health and Sport
School of Physiotherapy
2 Promethean Way, Robina, QLD, 4226
Country 113211 0
Australia
Phone 113211 0
+61408051943
Fax 113211 0
Email 113211 0
[email protected]
Contact person for scientific queries
Name 113212 0
Adam Walker
Address 113212 0
Bond University Institute of Health and Sport
School of Physiotherapy
2 Promethean Way, Robina, QLD, 4226
Country 113212 0
Australia
Phone 113212 0
+61408051943
Fax 113212 0
Email 113212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator via email at [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13064Ethical approval  [email protected] 382538-(Uploaded-01-09-2021-12-47-18)-Study-related document.pdf
13065Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.