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Gait retraining interventions for people with knee osteoarthritis

Toe-in and toe-out gait retraining intervention for reducing medial tibiofemoral joint load in people with knee osteoarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000367145
Enrollment
18
Registered
2019-03-08
Start date
2019-07-17
Completion date
2019-09-03
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Dr Milena Simic
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026