Footwear for self-managing knee osteoarthritis symptoms: protocol for the Footstep randomised controlled trial
Bibliographic record
Abstract
BACKGROUND: Knee osteoarthritis (OA) is a leading cause of musculoskeletal pain and disability globally, and abnormal knee loading is central to disease pathogenesis. Clinical guidelines recommend clinicians provide advice regarding appropriate footwear for people with knee OA, yet there is little research comparing the effects of different footwear on knee OA symptoms. Research suggests that wearing flat flexible shoes is associated with lower knee joint loads compared to stable supportive shoe styles. This two-arm pragmatic, comparative effectiveness randomised controlled trial will compare the effects of daily use of flat flexible shoes and stable supportive shoes on knee OA clinical outcomes, over 6 months. METHODS: 164 people with symptomatic medial tibiofemoral OA of moderate to severe radiographic severity (Kellgren and Lawrence Grade 3 & 4) will be recruited from the community. Following baseline assessment, participants will be randomly allocated to receive either i) flat flexible shoes or; ii) stable supportive shoes. Participants will choose two different pairs of shoes from a selection that fulfil the criteria in their allocated shoe class. Limited disclosure will blind participants to group allocation. Participants will be instructed to wear their allocated shoes daily for 6 months (minimum of 6 h/day), after which participants will be reassessed. The primary outcomes are knee pain severity on walking (measured by numerical rating scale) and self-reported physical function (measured by the Western Ontario and McMaster Universities Osteoarthritis Index), assessed at baseline and 6 months. Secondary outcomes include additional measures of knee pain, function, sport and recreation participation and quality-of-life (measured using subscales of the Knee Osteoarthritis Outcome Score), as well as pain at other sites (measured by numerical rating scale), self-reported global ratings of change in pain and physical function (measured by 7-point rating scale), and physical activity levels (measured by Physical Activity Scale for the Elderly). DISCUSSION: This study will determine whether daily wear of flat flexible shoes improves clinical outcomes in the management of knee OA, compared to stable supportive shoes. Findings will assist clinicians in providing evidence-based advice regarding appropriate footwear for people with knee OA to self-manage symptoms. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN12617001098325 . Registered 28/07/2017.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".