Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000564459
Ethics application status
Approved
Date submitted
19/04/2016
Date registered
2/05/2016
Date last updated
12/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Is targeted physiotherapy effective in improving outcomes, quality of life and return to activity in patients that are at risk of deteriorating symptoms and early osteoarthritis following anterior cruciate ligament reconstruction.
Scientific title
An exploration of the feasibility of a randomised clinical trial for physiotherapy intervention in patients at high risk of early-onset knee osteoarthritis and symptomatic decline following anterior cruciate ligament reconstruction.
Secondary ID [1] 288402 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
TASK (TasmaniaKnee)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anterior cruciate ligament reconstruction 297408 0
Condition category
Condition code
Musculoskeletal 297595 297595 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 298570 298570 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The targeted physiotherapy intervention group will complete eight 1:1 physiotherapy sessions (duration = 30 minutes) over 16 weeks, (1 x week for 4 weeks, then every 3 weeks for 12 weeks). These sessions will be conducted at BodySystem sports medicine clinic by two experienced physiotherapists (>5 years clinical experience in treating lower limb musculoskeletal conditions). This will occur immediately following a baseline assessment session with investigator BH at 12 months post ACLR.

Physiotherapy in this pilot RCT will have a distinct focus on functional retraining split into “progressive phases”. These phases are similar to a neuromuscular retraining intervention that has led to clinically meaningful changes in self-reported QoL in knee injury populations (articular cartilage lesions) with ongoing functional deficits following a similar period of routine rehabilitation.

There are 7 main "tasks" or exercises:
1. Balance
2. Functional strength
3. One Leg Rise
4. Posterior chain strength
5. Power
6. Multidirectional Movement
7. Sport Specific/Cardiovascular exercise
Each task, will have progressive phases within it. For example, "one leg rise" will start at phase one of a bilateral sit to stand, then once the pass criteria is met (x 30 to 90 degrees, nil pain or response in the knee), they move to an assisted one leg rise, then to an unassisted one leg rise, then to a single leg squat, then to a star excursion exercise.
The 7th category of "sport specific/cardiovascular exercise," is also phased. For example, they may not have began running, so phase 1 starts at walking/bike/swimming, then once they have passed the criteria (range of strength, control and balance tests) they may move to running.
See attached document for working examples of the above described Tasks – One Leg Rise and Sport Specific/Cardiovascular.

The 1:1 physiotherapy sessions will be used to review the rehabilitation program. They will be given the appropriate exercises from each of the 7 tasks to perform at home. These home exercise sessions will be approximately 30 -45 minutes depending on the level of the patient. Tasks 1-5 must be completed at a minimum of 3 times per week, maximum of 5, at the discretion of the physiotherapist and patient. For tasks 6 and 7, as this may involve some agility exercises, running or sport specific drills, this will completed in addition to Tasks 1 -5 and up to the discretion of the physiotherapist, pending on the level of the patient. If the patient is at a lower level then they may be doing bike in Task 7, and therefore this could be completed at the same time as their exercises in Tasks 1 – 5, i.e. minimum 3 times a week, maximum of 5, at discretion of physiotherapist. However, if the patient is at the higher level, they may perform exercises (Task 1 -5) 3 x week, and then perform x 2 running and agility sessions on top of this. The duration and frequency of these sessions will vary depending on the level of the patient, and will be up to the discretion of the treating physiotherapist.

Participants will be required to keep a "log book" to measure compliance of their home exercise program via the app on their smart device/computer. They will also have the option of paper version if not able to use the app. In addition to compliance, use of medications, other treatments, and symptoms will be monitored. Physiotherapists will also mark attendance at each of the physiotherapy sessions. They will also perform standardised assessment (balance, strength, function) at each physiotherapy session, which may improve adherence, This will be recorded by the physiotherapists in a log book.

Education component:
- Session 1: Increased risk of OA is not decreased with ACLR and important to have strong muscles to support knee. Understanding of OA pathology and progression.
Session 2: Benefits of physical activity – strength gains, decreased joint load, weight loss, evidence based conservative management for osteoarthritis. Fear avoidance addressed as appropriate. Why the exercises they are prescribed are important
- Session 3: Benefits of improving diet, weight loss, neuromuscular benefits, natural anti-inflammatory foods, and role in management of joint health. Benefits of dietician management and referral advice as appropriate.
- Session 4: Activity level modification advice as appropriate and return to sport/activity education – need to be >90% than other limb on certain tests. Patients’ specific goals and how to most appropriately achieve these. Benefits of psychology in returning to sport/activity and goal setting.
This will be delivered via an information booklet in the first session. And then verbal discussion of each of the topics in 5 – 10 minute blocks at each of the following 1:1 physiotherapy sessions. This will also direct them to external resources such as: http://daa.asn.au/for-the-public/smart-eating-for-you/
Intervention code [1] 293709 0
Rehabilitation
Comparator / control treatment
The “control group” will complete identical frequency and duration of 1:1 physiotherapy sessiodn (8 sessions over 16 weeks, 30 minutes duration each session, 1 x week for 4 weeks, then every 3 weeks for 12 weeks). These will also be conducted at BodySystem sports medicine clinic by the same two experienced physiotherapists (>5 years clinical experience in treating lower limb musculoskeletal conditions). The control group will also undergo a baseline assessment session with investigator BH at 12 months, and will commence the physiotherapy sessions immediately after this.

Each 30 minute 1:1 physiotherapy session will involve the following:

- 5 – 10 minutes of the same education delivered to the intervention group described above
- Phased progressive core strengthening - provided to give control group an active intervention and control for placebo effects of this. Core exercises will be graded in progressive phases and minimise lower limb involvement. See attached excel spreadsheet – “Control Group Intervention.” The session will be used to demonstrate and perform exercises and modify home exercise program
- Stretching program – this session will also be used to perform, prescribe and monitor stretching.
- Home exercise program: Education on activities that can be performed i.e. walking, bike. Aim for total of 30 – 60 minutes, depending on level, minimum 3-x week, including the core and stretching program. This will be completed at home.

Participants in the control group will also be required to keep a "log book" to measure compliance of their home exercise program via the app on their smart device/computer. They will also have the option of paper version if not able to use the app. In addition to compliance, use of medications, other treatments, and symptoms will be monitored. Physiotherapists will also mark attendance at each of the physiotherapy sessions. They will also perform standardised assessment at each physiotherapy session, specific to the phase of core strengthening that they are up to. This will be recorded by the physiotherapists in a logbook.
Control group
Active

Outcomes
Primary outcome [1] 297139 0
Knee-related QoL
- via KOOS and ACL-QoL
Timepoint [1] 297139 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [1] 320143 0
Perceived global change score
Participants will rate their perceived change following treatment on a 5-point ordinal scale (much improved, improved, no change, worse and much worse.
Timepoint [1] 320143 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [2] 320144 0
International Knee Documentation Committee (IKDC) subjective knee evaluation form
Timepoint [2] 320144 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [3] 320145 0
Tegner Activity Scale


Timepoint [3] 320145 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [4] 320146 0
International Physical Activity Questionnaire (IPAQ)
Timepoint [4] 320146 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [5] 323020 0
Anterior cruciate ligament return to sport after injury scale (ACL-RSI)
Timepoint [5] 323020 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [6] 323088 0
Tampa Scale for Kinesiophobia
Timepoint [6] 323088 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [7] 323089 0
Anterior Knee Pain Scale (AKPS)
Timepoint [7] 323089 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [8] 323090 0
Self Efficacy of knee function scale
Timepoint [8] 323090 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [9] 323092 0
Marx Activity Scale
Timepoint [9] 323092 0
Baseline = 6 months post ACLR
Monthly from 6 - 12 months post ACLR
Secondary outcome [10] 323093 0
Swelling, as measured by the physiotherapist using the stroke test.
Scoring methods: Zero - 3+
Zero = no wave produced on downstroke.
Trace: small wave on medial side with downstroke. 1+ = large bulge on medial side with downstroke.
2+ = effusion spontaneously returns to medial side after upstroke.
3+ = so much fluid that it is not possible to move the effusion out of the medial side of the knee.
Timepoint [10] 323093 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [11] 323094 0
One leg rise test
Timepoint [11] 323094 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [12] 323095 0
Single leg hop for distance, reported in cm each limb
Timepoint [12] 323095 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [13] 323096 0
Strength of quadriceps - seated knee extension isometric hand held dynamometer at 30 degrees. (therapist assisted via external belt stabilisation).
Timepoint [13] 323096 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [14] 323097 0
Video of single leg squat (SLS) and single leg drop jump (SLDJ).

The quality of these movements will be assessed by experienced clinician researchers, and rated by the following functional alignment criteria:
For the SLS: Rated as good, fair or poor.
For a subject to be rated “good” they must achieve 7/8 of the following criteria.
For a subject to be rated “fair” they must achieve 5/8 of the following criteria.
For a subject to be rated "poor" achieve <5/8 of the following criteria

– Maintain balance
– Perform the movement smoothly
– Squat must be to at least 60 degrees
– No trunk movement (lateral deviation, rotation, lateral flexion, forward flexion)
– No pelvic movement (shunt or lateral deviation, rotation, or tilt)
– No hip adduction or internal rotation
– No knee valgus
– Centre of knee remains over centre of foot

For the SLDJ:
- See attached functional alignment criteria scoring method document
Timepoint [14] 323097 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [15] 323100 0
Single Leg Balance
Timepoint [15] 323100 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [16] 323295 0
Range of Motion:
Flexion: measured supine with long arm goniometer
Extension: measured by prone leg hang
Timepoint [16] 323295 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [17] 323296 0
Crepitus:
measured by the baseline assessor through active flexion/extension as the feeling of grinding/cracking/vibrations with the hand over the patella.
Timepoint [17] 323296 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [18] 323297 0
Quadriceps Circumference
Measured with measuring tape, 10cm above the centre of the knee cap
Timepoint [18] 323297 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [19] 323298 0
strength gluteals - assessed by hand held dynamometry:
- hip abduction (side-lying)
- hip external and internal rotation (prone)
- hip extension (prone)
Also using belt to stabilise and assist the therapist.
Timepoint [19] 323298 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [20] 323299 0
strength of calf assessed by maximum number of single leg heel raises on each leg (with full height, good form and technique).
Timepoint [20] 323299 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [21] 323300 0
strength of core assessed by side plank endurance (maximum number of seconds able to hold in correct position up to 1 minute). Compared to the other side and normative/acceptable values.
Timepoint [21] 323300 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [22] 323301 0
strength of hamstrings assessed by hand held dynamometry prone, at 15 degrees and 45 degrees.
Timepoint [22] 323301 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [23] 323302 0
triple crossover hop for distance, reported in cm each limb
Timepoint [23] 323302 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)
Secondary outcome [24] 323303 0
Side hop test. Reported as maximum number of hops each limb in 30 seconds. Patient to hop sideways over 40cm taped lines.
Timepoint [24] 323303 0
Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)

Eligibility
Key inclusion criteria
(i) aged 18-50 years; (ii) primary arthroscopic ACLR with a hamstring-tendon autograft 6 months prior; (iii) evidence of poor knee function at 12 months as defined by:
< 87.5 on KOOS-QoL score AND meeting one the following three criteria:

1. <22 on the one leg rise task OR
2. <88% LSI on single leg hop for distance
3. <87 on the AKP scale

Please note that patients will be recruited at 6 months post ACLR into a recruitment pool. From this point we will monitor their activity level from 6 -12 months as it has been shown significant bone and cartilage changes occur in this time point, and it has been suggested that those that participate early in cutting/impact activities may have greater changes. At 12 months, each patient who had agreed to be contacted for eligibility at 12 months will be re contacted, The patients will then be invited to attend an eligibility testing session at BodySystem clinic, of which the KOOS- QoL, one leg rise, single hop for distance and AKP scale will be administered by a physiotherapist who will not be involved in the treatment intervention. If eligible they will book an appointment for physiotherapy 1:1 session, to begin as soon as possible.
Note: The patients will be informed on the possibility at 6 months that they may not be eligible for the study.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) previous injury/symptoms in the ACL injured knee; (ii) >5 years between ACL injury and reconstruction; (iii) subsequent injury (for which medical treatment was sought) or follow-up surgery to the ACLR knee; (v) another condition influencing daily function; (iv) inability to understand written and spoken English.

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)
Update
The randomisation schedule, generated and maintained centrally by AI Crossley
The method of allocation and randomisation will be performed by AI Crossley at La Trobe University, Bundoora, VIC via central computer randomisation (to either Group A (intervention) or Group B (control)). As patients may be recruited at staggered time points, the computer randomisation will be set up so that there is a random sequence of "A" or "B" that will result in 16 "A" and 8 "B" by the end point of recruitment.

As allocated - the group (A or B) will be revealed and communicated to the 2 administrating physiotherapists at BodySystem via investigator KC. Investigator BH who will be processing the patient-reported outcomes and physical test results at baseline and 3-months, will remain blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary QoL outcome measured at 16 weeks will be analysed using linear mixed regression models, including the baseline score as a covariate, subjects as a random effect, treatment condition as a fixed-factor and the covariate by treatment interaction. Participant characteristics (e.g. gender, age) will be included as covariates. Secondary outcomes assessing feasibility will include recruitment rate, compliance with all aspects of intervention, drop-out rate and any adverse events. We aim to detect the minimum clinically important improvement on the self-reported outcomes as published by Singh et al (2014). The effect sizes (mean and SD) of the targeted physiotherapy intervention for each of the secondary clinical outcome measures will also be calculated. These will be used for the sample size calculations for a future large-scale RCT All analyses will be conducted in a blinded manner, on an intention-to-treat basis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2016
Actual
24/01/2017
Date of last participant enrolment
Anticipated
1/12/2017
Actual
16/08/2017
Date of last data collection
Anticipated
Actual
16/04/2018
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
TAS,VIC
Recruitment postcode(s) [1] 23441 0
3122 - Hawthorn
Recruitment postcode(s) [2] 13097 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 293415 0
Charities/Societies/Foundations
Name [1] 293415 0
Physiotherapy Research Foundation
Country [1] 293415 0
Australia
Primary sponsor type
Individual
Name
Professor Kay Crossley
Address
School of Allied Health, College of Science, Health and Engineering
La Trobe University, Bundoora, Vic 3086
Country
Australia
Secondary sponsor category [1] 292241 0
Individual
Name [1] 292241 0
Adam Culvenor
Address [1] 292241 0
School of Allied Health, College of Science, Health and Engineering
La Trobe University, Bundoora, Vic 3086
Country [1] 292241 0
Australia
Secondary sponsor category [2] 292255 0
Individual
Name [2] 292255 0
Brooke Howells
Address [2] 292255 0
School of Allied Health, College of Science, Health and Engineering
La Trobe University, Bundoora, Vic 3086
Country [2] 292255 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294863 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 294863 0
La Trobe University, Bundoora, Vic 3086.
Ethics committee country [1] 294863 0
Australia
Date submitted for ethics approval [1] 294863 0
13/06/2016
Approval date [1] 294863 0
09/09/2016
Ethics approval number [1] 294863 0
HEC16-077

Summary
Brief summary
Osteoarthritis (OA) is the leading cause of musculoskeletal pain and disability in older adults. The prevalence of knee OA is as high as 50-90% a decade after anterior cruciate ligament injury, irrespective of conservative or surgical management (ACL reconstruction). Our recent magnetic resonance imaging (MRI) data has revealed evidence of OA as early as one year post-ACLR in up to one-third of younger adults – “young people with old knees.” This early-onset OA is frequently associated with pain, reduced physical function, and ultimately, decreased quality of life (QoL) in people aged less than 50 years.Therefore, interventions with potential to reduce pain, improve function and optimise QoL in this population are urgently required.
It is known that individuals most at risk of persistent and worsening knee symptoms after ACLR were those with poor knee function 12 months post-and these individuals are more likely to have deteriorating quality of life over the following two years. Post-operative ACLR rehabilitation programs typically aim to decrease pain and improve function to ultimately facilitate a return to competitive sport during the first 12 months post-surgery. There is strong evidence that rehabilitation programs, including progressive resistance and neuromuscular training, have beneficial effects on pain and knee function in patients following rupture of the ACL. However, optimal function and return to sport is not restored in many individuals at 12 months post ACLR, potentially reflecting inadequate rehabilitation participation, and/or insufficient strength/neuromuscular exercise progression.
The 12-months post-surgical milestone provides an ideal window to identify those with functional impairments who are at risk of symptomatic deterioration and for interventions that target this group to be implemented. No studies have examined either the feasibility or effectiveness of physiotherapy treatment that aims to enhance self-reported outcomes by targeting specific dysfunction in patients who have persistent functional impairments following ACLR.
We hypothesise that a targeted physiotherapy program will improve outcomes in those that are at risk of deteriorating symptoms and early OA following ACLR compared to a control group, who do not receive targeted physiotherapy. The outcomes that we are interested in improving are self reported symptoms, function/return to sport, and quality of life. We will also be assessing whether gains can be made in strength and neuromuscular control at this 12-month post ACLR stage, and whether this is related to improvements in the self reported outcomes. We hypothesise that both groups will improve, however the targeted physiotherapy group will have significantly more gains.
Trial website
NA
Trial related presentations / publications
NA
Public notes
NA
Attachments [1] 849 849 0 0
/AnzctrAttachments/369986-Control Intervention.docx
Attachments [2] 850 850 0 0
/AnzctrAttachments/369986-Targeted Intervention Outline Tasks 1 -4.docx
Attachments [3] 851 851 0 0
/AnzctrAttachments/369986-Targeted Intervention Outline Task 5-6 plus sport specific.docx
Attachments [4] 864 864 0 0
/AnzctrAttachments/369986-functional alignment criteria SLDJ.docx
Attachments [5] 921 921 0 0
/AnzctrAttachments/369986-TASK 1 Single Leg Control.pdf
Attachments [6] 922 922 0 0
/AnzctrAttachments/369986-TASK 7 Sport Specific or Cardiovascular.docx

Contacts
Principal investigator
Name 63002 0
A/Prof Kay Crossley
Address 63002 0
School of Allied Health, College of Science, Health and Engineering
La Trobe University, Bundoora Vic 3086
Country 63002 0
Australia
Phone 63002 0
+613 9479 3902
Fax 63002 0
+613 9479 5768
Email 63002 0
K.Crossley@latrobe.edu.au
Contact person for public queries
Name 63003 0
Miss Brooke Howells
Address 63003 0
School of Allied Health, College of Science, Health and Engineering
La Trobe University, Bundoora Vic 3086
Country 63003 0
Australia
Phone 63003 0
+613 9479 3902
Fax 63003 0
+613 9479 5768
Email 63003 0
B.Howells@latrobe.edu.au
Contact person for scientific queries
Name 63004 0
Miss Brooke Howells
Address 63004 0
School of Allied Health, College of Science, Health and Engineering
La Trobe University, Bundoora Vic 3086
Country 63004 0
Australia
Phone 63004 0
+613 9479 3902
Fax 63004 0
+613 9479 5768
Email 63004 0
B.Howells@latrobe.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExercise-therapy and education for individuals one year after anterior cruciate ligament reconstruction: a pilot randomised controlled trial.2021https://dx.doi.org/10.1186/s12891-020-03919-6
N.B. These documents automatically identified may not have been verified by the study sponsor.