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Trial registered on ANZCTR


Registration number
ACTRN12619000367145
Ethics application status
Approved
Date submitted
1/03/2019
Date registered
8/03/2019
Date last updated
29/11/2019
Date data sharing statement initially provided
8/03/2019
Date results information initially provided
29/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Gait retraining interventions for people with knee osteoarthritis
Scientific title
Toe-in and toe-out gait retraining intervention for reducing medial tibiofemoral joint load in people with knee osteoarthritis
Secondary ID [1] 297566 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis
311815 0
Condition category
Condition code
Musculoskeletal 310420 310420 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 310421 310421 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the toe-in gait retraining group will be set an aim to achieve an altered foot progression angle (FPA) that is 10 degrees more in the toe-in direction from the participant’s natural FPA. The toe-out gait retraining group will be instructed to aim to achieve an altered FPA that is 10 degrees more in the toe-out direction from the participant’s natural FPA.
Supervised sessions will be carried out by a final year physiotherapy student (TO). Gait analysis to aid achievement of the target FPA during weekly supervised sessions will be performed using the Zeno walkway at the University of Sydney, Faculty of Health Sciences, Sydney Performance laboratory (N101). The Zeno walkway involves a pressure sensitive walkway connected to a computer to analyse walkway activity through the ProtoKinetics Movement Analysis Software (PKMAS). Participants will be asked to walk at their self-selected speed along the walkway starting from several steps before the walkway and continuing for several steps beyond the walkway, before coming to a stop. The use of the OPAL system by APDM will also be piloted to aid training of target FPA. It involves wearable sensors consisting of a tri-axial accelerometer, tri-axial gyroscope and tri-axial magnetometer, which can assess gait parameters, including FPA, in outdoor environments outside of the motion analysis laboratory.
Feedback on performance will be provided verbally or with visual feedback by the student clinician, who will be guided by data collected using the Zeno walkway or OPALs system. Verbal qualitative feedback regarding movement patters required for the task will also be provided. The relative frequency of feedback will be progressively decreased with progressive weeks. Specifically, this will include reduced frequency of feedback regarding achieved FPA and reduced verbal cueing to assist corrections in FPA.
In total, the intervention will be carried out over six weeks. The gait retraining program will involve weekly supervised sessions (once a week) using the Zeno walkway/OPALs system. Participants will also be required to practice their altered FPA daily at home (unsupervised home-based self-practice), which will be monitored with a logbook. In each session, the participant will be required to achieve certain goals. During the session in weeks 0-1, the participant will walk with the altered FPA using the Zeno walkway and be taught by the physiotherapy student a self-practice strategy using the participants’ smart phone camera. In weeks 2-3, the participant must achieve walking with altered FPA on Zeno walkway whilst also completing simple cognitive tasks (such as counting backwards in 3’s). In weeks 4-5, the participant must achieve walking with altered FPA, whilst walking on grass using the OPALs system. The first training session will run for 1 hour and will involve education of the participant, baseline assessments and commencement of the intervention program (week 0). The following five sessions (week 1 to 5) will be spaced one week apart, consisting of supervised gait retraining sessions of 30 minutes. The final session will be performed one week after the sixth session (week 6) at the completion of the gait retraining program and will involve re-assessment of outcome measures. The participants will also be prescribed a home-based program of 30 minutes per day during this 6-week period. Adverse events from the gait retraining program will also be monitored using the logbook.
Intervention code [1] 313819 0
Treatment: Other
Comparator / control treatment
Toe out group
Control group
Active

Outcomes
Primary outcome [1] 322129 0
Patient-rated acceptability of the intervention.
Participants will be asked “if the gait modification is found be beneficial for knee OA, how likely are you to use this strategy?” They will then be asked to rate this level of acceptability on a VAS ranging from 0 to 10, with 0 being extremely unlikely and 10 being extremely likely.
Timepoint [1] 322129 0
6 week assessment
Primary outcome [2] 322130 0
Adherence will be monitored by (1) adherence to therapist sessions (the total number of supervised sessions attended), and (2) adherence to prescribed self-practice. Adherence to self-practice will be assessed via logbook data and represented as weekly averages of time (in minutes) practiced per day, calculated as the weekly total time practiced divided by the number of days between weekly supervised sessions.
Timepoint [2] 322130 0
6 week
Secondary outcome [1] 367688 0
Pain
Western Ontario and McMaster Universities Osteoarthritis Index
Timepoint [1] 367688 0
Week 0 and 6
Secondary outcome [2] 367689 0
Knee symptom duration
Participants will be asked how long they have had their knee symptoms for (e.g. 2 years)
Timepoint [2] 367689 0
Week 0 and 6
Secondary outcome [3] 367690 0
Knee injury history
Participants will be asked to indicate whether they have had a previous knee injury (Yes/No)
Timepoint [3] 367690 0
Week 0 and 6
Secondary outcome [4] 367691 0
Medication use
Participants will be asked to complete a survey that asks the name of the medication they use, the dosage, frequency of use, length of use, reasons for using the medications for pain relief, who prescribed the medication and any side effects from the medication.
Timepoint [4] 367691 0
Week 0 and 6
Secondary outcome [5] 367692 0
Foot progression angle
3D motion analysis
Timepoint [5] 367692 0
Week 0 and 6
Secondary outcome [6] 367694 0
Late stance peak adduction moment (KAM)
3D motion analysis
Timepoint [6] 367694 0
Week 0 and 6
Secondary outcome [7] 367695 0
Late stance peak adduction moment (KAM) impulse
3D motion analysis
Timepoint [7] 367695 0
Week 0 and 6
Secondary outcome [8] 367696 0
Varus thrust
3D motion analysis
Timepoint [8] 367696 0
Week 0 and 6
Secondary outcome [9] 367697 0
Spatial temporal gait parameters
3D motion analysis
Timepoint [9] 367697 0
Week 0 and 6
Secondary outcome [10] 367852 0
Pain
11-point Visual Analogue Scale (VAS)
Timepoint [10] 367852 0
Week 0 and 6
Secondary outcome [11] 367993 0
Physical function
Western Ontario and McMaster Universities Osteoarthritis Index
Timepoint [11] 367993 0
Week 0 and 6
Secondary outcome [12] 377439 0
Achievability of target foot progression angle (FPA) will be analysed by extent to which participants were able to meet their target 10 degree change towards their new FPA.
The gait intervention will be considered achievable if participants achieved 80% of their target FPA (i.e. achieved at least an 8 degree change to their FPA). Achievability will be analysed based on the index leg (i.e. the side with the most symptomatic knee). Achievability of FPA will be assessed using the Zeno Walkway Gait Analysis System.
Timepoint [12] 377439 0
6 week
Secondary outcome [13] 377440 0
Recruitment rate
Timepoint [13] 377440 0
6 week
Secondary outcome [14] 377441 0
Data completeness will be evaluated as a percentage of the number of assessments completed by all participants out of total number of assessments. Data completeness is aimed at 85%. Drop-out rate will also be evaluated, with feasibility considered 15%.
Timepoint [14] 377441 0
6 week
Secondary outcome [15] 377442 0
Adverse events, defined as an increase in pain will be monitored by the therapist during supervised sessions. Symptoms will be also monitored on a weekly basis via the logbook, in which participants report on any increase in pain (and other symptoms such as muscle soreness, stiffness or swelling) during their self-practice. An adverse effect is defined as >2-point increase in pain on VAS during supervised sessions, any increase in pain lasting >48 hours, or requiring medical attention.
Timepoint [15] 377442 0
Week 0, 1, 2, 3, 4, 5, and 6
Secondary outcome [16] 377443 0
Change in the late stance peak knee adduction moment during self-selected walking. This will be measured using three-dimensional gait analysis at baseline and follow-up. The late stance peak KAM has been identified to be a proxy measure of medial knee joint load and is associated with knee OA disease severity.
Timepoint [16] 377443 0
Week 6

Eligibility
Key inclusion criteria
- Display clinical signs of knee osteoarthritis according to the National Institute for Health and Care Excellent (NICE) guidelines (2014), which involves being 45 years or older, having activity-related joint pain, and having either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes
- Mostly reporting medial knee pain
- Reporting average knee pain of 3 or more (out of 10) on a visual analogue scale with 0 representing no pain and 10 representing worst pain imaginable
- Able to walk unaided for at least 30 minutes
Minimum age
45 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of knee arthroplasty or injection within the past 6 months
- History of joint replacement surgery involving the knee or hip of the affected side
- Neurological conditions affecting ambulation
- Other systematic rheumatologic conditions affecting joints (e.g. rheumatoid arthritis)
- Spinal pain with lower limb symptoms

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)
Random allocation will be performed by an independent researcher using a random number generator. Equal allocation will be set to produce two groups of 10, with allocation concealment of the researcher and participants. However, due to nature of intervention, it will not be possible to blind the researcher or participants when delivering the interventions
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation schedule will be arranged using a random number generator by an independent researcher not involved in the delivery of interventions or assessment procedures (MS). The order will be uploaded to RedCap, and only accessible to the sole researcher. Participants will automatically be allocated following completion of all baseline assessments. The student physiotherapist delivering the intervention will be notified of the allocation via email, automatically generated by the RedCap system.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Quantitative data collected will be analysed to investigate the preliminary effects of the 6-week intervention on pain, physical function and knee load. Data will firstly be analysed for normality. If normally distributed data, between group differences from baseline will be assessed through independent sample t-test. In addition, linear mixed modelling will be used to analyse within group differences of outcome measures from baseline to final. Any missing data will be addressed as an intention to treat, with inclusion of all participants in the data analysis with the use of the last observation being carried forward. The hypotheses will be tested with a significance level of 0.05.

Recruitment
Recruitment status
Active, not 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] 302118 0
Self funded/Unfunded
Name [1] 302118 0
None
Address [1] 302118 0
None
Country [1] 302118 0
Primary sponsor type
University
Name
Dr Milena Simic
Address
University of Sydney, Faculty of Health Sciences
Discipline of Physiotherapy
75 East Street
Lidcombe
NSW 2141
Country
Australia
Secondary sponsor category [1] 301951 0
None
Name [1] 301951 0
Address [1] 301951 0
Country [1] 301951 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302799 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 302799 0
University of Sydney
Level 3, Administration Building
University of Sydney
NSW 2006
Ethics committee country [1] 302799 0
Australia
Date submitted for ethics approval [1] 302799 0
Approval date [1] 302799 0
19/02/2019
Ethics approval number [1] 302799 0

Summary
Brief summary
Knee osteoarthritis (OA) is one of the leading causes of physical disability in adults. It leads to symptoms of pain, reduced functional mobility, poor quality of life, and causes a substantial burden to the healthcare system. Mechanical loading patterns at the knee are believed to play a major role in the pathological cartilage and bone changes seen in people with knee OA. Therefore, there has been increasing interest in gait modification strategies that act to reduce loading in the knee. One such strategy is altering the foot progression angle (FPA) via a toe in or out method. FPA refers to the angle formed by the long-axis of the foot, constructed from the mid-heel through to the second toe, and the forward progression of the body. The typical FPA during normal gait tends to occur with the toes pointing slightly outward at approximately 5 degrees. Toe-out gait is thus achieved through increasing the FPA by externally rotating the foot, whilst decreasing the FPA through internal rotation of the foot is referred to as a toe-in gait.

The primary objective of this study is to evaluate the effects of toe-in gait retraining intervention compared to toe-out gait retraining intervention on pain, physical function and proxy measures of medial knee load over 6 weeks in people with medial knee osteoarthritis. The design of the study will be a randomised clinical trial. Community dwelling individuals with medial knee OA will be recruited, screened and then randomly allocated to either a toe-in or toe-out gait retraining group for a 6 week intervention. To fulfil this knee OA diagnosis, participants must be over 45 years or older, with knee pain. To control for confounding variables, participants need to be free of neurological or systemic rheumatological conditions. Men and women will be invited to participate from the Sydney metropolitan region. The total sample size will be 60. Participants will be randomised with a 1:1 allocation to either receive toe-in intervention (30 participants) or toe-out intervention (30 participants).They will undergo a gait retraining intervention program for 6 weeks and are required to attend the laboratory a total of 7 times (including assessments). The first training session will run for 1 hour and will involve education of the participant, baseline assessments and commencement of the intervention program (week 0). The following five sessions (week 1 to 5) will be spaced one week apart, consisting of supervised gait retraining sessions of 30 minutes. The final session will be performed one week after the sixth session (week 6) at the completion of the gait retraining program and will involve re-assessment of outcome measures. The participants will also be prescribed a home-based program of 30 minutes per day during this 6-week period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91438 0
Dr Milena Simic
Address 91438 0

University of Sydney, Faculty of Health Sciences
Discipline of Physiotherapy
75 East Street
Lidcombe
NSW 2141
Country 91438 0
Australia
Phone 91438 0
+61 2 9351 9254
Fax 91438 0
Email 91438 0
milena.simic@sydney.edu.au
Contact person for public queries
Name 91439 0
Dr Milena Simic
Address 91439 0

University of Sydney, Faculty of Health Sciences
Discipline of Physiotherapy
75 East Street
Lidcombe
NSW 2141
Country 91439 0
Australia
Phone 91439 0
+61 2 9351 9254
Fax 91439 0
Email 91439 0
milena.simic@sydney.edu.au
Contact person for scientific queries
Name 91440 0
Dr Milena Simic
Address 91440 0

University of Sydney, Faculty of Health Sciences
Discipline of Physiotherapy
75 East Street
Lidcombe
NSW 2141
Country 91440 0
Australia
Phone 91440 0
+61 2 9351 9254
Fax 91440 0
Email 91440 0
milena.simic@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
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary