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Trial registered on ANZCTR


Registration number
ACTRN12621000414819
Ethics application status
Approved
Date submitted
21/12/2020
Date registered
15/04/2021
Date last updated
31/05/2024
Date data sharing statement initially provided
15/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Gait retraining interventions for medial knee osteoarthritis.
Scientific title
The effect of gait retraining interventions on patient-reported outcomes and proxy measures of medial knee load in individuals with medial knee osteoarthritis (OA).
Secondary ID [1] 303058 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 320120 0
Condition category
Condition code
Musculoskeletal 318067 318067 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 318298 318298 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
• Participants will be randomly allocated to either a toe-in, toe-out, or postural re-education gait retraining program for six weeks, followed by a booster session between the end of the intervention and the 3-month follow-up. The intervention program will be delivered by either a physiotherapist or podiatrist with a minimum of three years of experience.
• Participants will be required to attend the 3D gait analysis laboratory three times for the biomechanics assessment. The biomechanical assessment will involve the placement of reflective markers on the upper body and lower limb anatomical landmarks followed by the completion of five successful gait trials (clean foot strike for the most symptomatic limb). This assessment will be conducted at baseline, immediately following the 6-week intervention program and three months following the 6-week program.
• The first session will run for 1.5-2 hours as this will involve baseline biomechanical assessments, education for the participant, and commencement of the intervention program (week 0). Overall, participants will be receiving 4-6 supervised sessions over the initial 6 weeks, with the frequency determined by the therapist delivering the intervention.
• These sessions will consist of supervised one-on-one gait retraining sessions of 30 minutes, motivational interviewing, goal-setting, and walking with the altered foot progression angle (FPA)/ upright trunk. Sessions outline: In weeks 1-2, participants in all groups will aim to walk with altered foot progression angle (FPA) using the spatiotemporal Zeno Walkway or the OPAL wearable sensors. In weeks 2-4, participants will achieve walking with altered FPA or more upright trunk while dual-tasking (simple cognitive tasks involving counting backward in 3's). In weeks 5-6, participants will achieve walking with altered FPA, or more upright trunk whilst walking outdoors/various terrain using the OPAL wearable sensors. In addition to these supervised sessions during the 6- week period, participants will also be prescribed 30 minutes of their allocated gait strategy to practice each day at home. A logbook will be provided for participants to record adherence and any adverse events. Attendance will also be recorded by the physiotherapist or podiatrist delivering the intervention.
• Participants will be invited to a gait retraining session between finishing the intervention period and their final assessment (3 months post-intervention). Participants will be asked to attend a gait retraining booster session at week 12 but can be completed between weeks 9-15. During this session, participants will get a chance to obtain qualitative and quantitative feedback from the therapist regarding their prescribed gait change.
Intervention code [1] 319339 0
Treatment: Other
Comparator / control treatment
Each of the gait retraining techniques, toe-in, toe-out, and postural re-education will be compared. All training programs will be supervised by a physiotherapist or a podiatrist. All programs will be delivered as 30-minute sessions over 6 weeks, 4-6 sessions depending on how the participant is achieving the gait strategy. This will be determined by the therapist delivering the program.

The gait retraining sessions will be one-on-one. Logbooks will be completed and checked by the therapist at each session. Attendance of sessions will be recorded on REDCap.

Participants in each group will undergo the same biomechanical assessments at the same time points and will have to perform the 30-minute practice of the allocated gait strategy at home as part of this home program.
Control group
Active

Outcomes
Primary outcome [1] 331202 0
Three-dimensional gait analysis. Participants will be asked to walk barefoot at their comfortable walking speed. Gait will be collected over an average of 5 trials, using a 20 camera Vicon Vantage system and embedder Kistler force plates. This will be assessed at the baseline, 6-week, and 3-month follow-up time points using the 3D gait analysis laboratory. The primary biomechanical outcome of interest will be proxy measures of medial knee joint load. This includes the early- and late-stance peak knee adduction moment (KAM), KAM impulse, and varus thrust.
Timepoint [1] 331202 0
Baseline, six-weeks and 3-month follow-up
Secondary outcome [1] 393976 0
SF-12- Questionnaire- a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. This questionnaire will be completed by participants via REDCap
Timepoint [1] 393976 0
Baseline, 6-weeks and 3- month follow-up
Secondary outcome [2] 393977 0
30-second chair stand test (30s-CST): This test involves recording the maximum number of chair stand repetitions possible in a 30 second period. If a participant uses their upper limb for support, this will be recorded.
Timepoint [2] 393977 0
Baseline and 3-month follow-up
Secondary outcome [3] 393979 0
Health care utilisation form to assess the use of health services. This form will be completed by participants via REDCap
Timepoint [3] 393979 0
Baseline and 3-month follow-up
Secondary outcome [4] 393980 0
Medication use i.e.: prescription and non-prescription analgesia and supplementation for knee OA. This will be completed by participants via REDCap
Timepoint [4] 393980 0
Baseline, 6-weeks and 3-month follow-up
Secondary outcome [5] 393981 0
Treatment credibility questions to assess patient outcome expectations. These questions will be completed by participants via REDCap
Timepoint [5] 393981 0
Following the first intervention session.
Secondary outcome [6] 393998 0
Fidelity of blinding and participant-reported improvement: Following the disclosure (HREC approved debrief statement), the therapist will ask the participants two questions at the 3-month follow-up. These questions require the participant to judge if their knee symptoms have improved and if they thought they were in the active or placebo group.
Timepoint [6] 393998 0
3-month follow-up
Secondary outcome [7] 394082 0
40 meters fast-paced walk test (40M FPWT): A fast-paced walking test that is timed over a 4x 10m (33ft) for a total of 40 m. This measures speed over short distances and changing direction during walking, an important but often limited activity in individuals with OA.
Timepoint [7] 394082 0
Baseline and 3-month follow-up
Secondary outcome [8] 394083 0
Stair climb test (SCT): A test of ascending and descending stair activity. We will record the time (in seconds) it takes to ascend and descend a flight of stairs. Prior to this test, we will conduct a trial to determine the participant’s ability to ascend/descend stairs safely. If they are deemed unsafe, we will not conduct this assessment.
Timepoint [8] 394083 0
Baseline and 3-month follow-up
Secondary outcome [9] 404486 0
Self-reported physical function assessed through Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
Timepoint [9] 404486 0
Baseline, 6-weeks and 3-month follow-up
Secondary outcome [10] 409165 0
Change in knee pain during walking using the numeric pain rating scale (0-10)
Timepoint [10] 409165 0
Baseline, six-weeks and 3-months follow-up
Secondary outcome [11] 409166 0
Biomechanical variables affecting the hip joint (kinetic, kinematic) through 3D gait analysis.
Timepoint [11] 409166 0
Baseline, six-weeks, 3-moth follow-up
Secondary outcome [12] 409167 0
Biomechanical variables affecting the knee joint (kinetic, kinematic) through 3D gait analysis and 2D video cameras
Timepoint [12] 409167 0
Baseline, six-weeks and 3-month follow-up
Secondary outcome [13] 409168 0
Biomechanical variables affecting the ankle joint (kinetic, kinematic) through 3D gait analysis.
Timepoint [13] 409168 0
Baseline, six-weeks and 3-month follow-up
Secondary outcome [14] 409169 0
Spatiotemporal variables measured through 3D gait analysis.
Timepoint [14] 409169 0
Baseline, 6-weeks, 3-month follow-up

Eligibility
Key inclusion criteria
People will be included if they display clinical signs of knee OA according to the National Institute for Health and Care Excellence (NICE) guidelines, which involves being 45 years old or older, having activity-related joint pain, and having either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 mins. Participants will be included if they report medial knee pain, and average knee pain of greater or equal to 1/10 on a visual analog scale (VAS) with 0 representing no pain, and 10 representing worst pain imaginable. Participants will be included if they are able to walk unaided for at least 30 mins and display evidence of knee OA based on clinical screening according to the American College of Rheumatology (ACR) Clinical Classification for Knee Osteoarthritis.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of knee arthroplasty 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, BMI 35 kg/m^2, self-reported genu valgum alignment.

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 number generator by a central researcher via computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will be using a stratified randomisation based on the presence/absence of varus thrust so that each intervention group has the same number of participants with and without varus thrust
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data collected will be analysed to investigate the preliminary effects of the 6-week intervention and 3-month follow-up on knee load. Data will firstly be analysed for normality. If normally distributed data, between-group differences from baseline, will be assessed through an analysis of variance. In addition, linear mixed modeling 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 the 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
Recruiting
Date of first participant enrolment
Anticipated
27/04/2022
Actual
26/05/2021
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
19/09/2024
Actual
Sample size
Target
90
Accrual to date
70
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307465 0
University
Name [1] 307465 0
The University of Sydney
Country [1] 307465 0
Australia
Funding source category [2] 308039 0
Hospital
Name [2] 308039 0
Westmead Charitable Trust Allied Health Career Development Grant
Country [2] 308039 0
Australia
Funding source category [3] 308040 0
Charities/Societies/Foundations
Name [3] 308040 0
Arthritis Australia National Research Program Scholarship
Country [3] 308040 0
Australia
Funding source category [4] 313558 0
Charities/Societies/Foundations
Name [4] 313558 0
Arthritis Australia National Research Program Project Grant
Country [4] 313558 0
Australia
Primary sponsor type
Individual
Name
A. Prof Milena Simic (CI)
Address
Faculty of Medicine and Health
The University of Sydney
Susan Wakil Health Building,
D 18 Western Avenue,
University of Sydney
Camperdown
NSW 2006
Country
Australia
Secondary sponsor category [1] 308765 0
None
Name [1] 308765 0
Address [1] 308765 0
Country [1] 308765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307542 0
University of Sydney Human Research Ethics Committee (HREC).
Ethics committee address [1] 307542 0
Level 3, Administration Building (F23) University of Sydney, NSW 2006
Australia
Ethics committee country [1] 307542 0
Australia
Date submitted for ethics approval [1] 307542 0
19/09/2020
Approval date [1] 307542 0
04/10/2020
Ethics approval number [1] 307542 0
2019/639

Summary
Brief summary
The primary objective of this 3- arm randomised controlled trial, is to evaluate the effects of gait retraining interventions on proxy measures of medial knee load (early- and late-stance peak KAM, KAM impulse, and varus thrust) in people with medial knee osteoarthritis. This will be assessed at baseline, six weeks after the initial assessment and three months following this.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
We commenced the study in May 2021, however due to COVID-19 and lockdowns, we were only able to enroll n=9 and complete the follow-ups for this group. This sample will not be part of the registered RCT. We will analyse the n=9 dataset separately as a pilot study.

Contacts
Principal investigator
Name 107606 0
A/Prof Milena Simic
Address 107606 0
Susan Wakil Health Building, D 18 Western Avenue, Faculty of Medicine and Health, University of Sydney Camperdown Campus, Camperdown NSW 2006
Country 107606 0
Australia
Phone 107606 0
+61 2 8627 6970
Fax 107606 0
N/A
Email 107606 0
milena.simic@sydney.edu.au
Contact person for public queries
Name 107607 0
Ms Nicole D'Souza
Address 107607 0
Susan Wakil Health Building, D 18 Western Avenue, Faculty of Medicine and Health, University of Sydney Camperdown Campus, Camperdown NSW 2006
Country 107607 0
Australia
Phone 107607 0
+61 2 8627 6970
Fax 107607 0
N/A
Email 107607 0
n.dsouza@sydney.edu.au
Contact person for scientific queries
Name 107608 0
Ms Nicole D'Souza
Address 107608 0
Susan Wakil Health Building, D 18 Western Avenue, Faculty of Medicine and Health, University of Sydney Camperdown Campus, Camperdown NSW 2006
Country 107608 0
Australia
Phone 107608 0
+61 2 8627 6970
Fax 107608 0
N/A
Email 107608 0
n.dsouza@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 will be aggregated for all publications


What supporting documents are/will be available?

No Supporting Document Provided



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.