Comparing the Impact of an Implicit Learning Approach With Standard Care on Recovery of Mobility Following Stroke: Protocol for a Pilot Cluster Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Although implicit and explicit learning approaches have been well investigated in healthy populations, there is less evidence regarding the relative benefits of each approach in clinical practice. Studies in stroke typically investigate single elements of an implicit learning approach (ILA; eg, reduced quantity feedback or an external focus of attention) within controlled environments. These studies predominantly evaluate performance, with few measuring this over time (ie, learning). The relevance and transferability of current research evidence into stroke rehabilitation is therefore limited. OBJECTIVE: The objective of this study was to compare the ILA with standard care in the acute phase following stroke, to generate data and insights to inform the design of a definitive trial, and to understand patient and therapist perceptions of the ILA. METHODS: This is a multicenter, assessor-blind, cluster randomized controlled pilot trial with nested qualitative evaluation. Stroke units (clusters) will be randomized to either ILA (intervention) or standard care (control) arms. Therapy teams at the intervention sites will be trained in the ILA and provided with an intervention manual. Those at the control sites will have minimal input from the research team, other than for data collection. Consent will be provided at the individual participant level. Once enrolled, participants will receive rehabilitation that focuses on lower limb recovery, using the designated approach. Measures will be taken at baseline, every 2 weeks until the point of discharge from hospital, and at 3 months post stroke onset. Measures include the Fugl Meyer Assessment (motor leg subsection), modified Rivermead Mobility Index, Swedish Postural Adjustment in Stroke Scale, and achievement of mobility milestones. Fidelity of the treatment approach will be monitored using observational video analysis. Focus groups and interviews will be used to gain insight into the perceptions of trial participants and clinical teams. RESULTS: The first site opened to recruitment in February 2019. The opening of a further 5 sites will be staggered throughout 2019. Results are expected in early 2021. CONCLUSIONS: The findings from this mixed methods pilot study will be used to inform the design of a definitive study, comparing the ILA with standard care in acute stroke rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03792126; https://clinicaltrials.gov/ct2/show/NCT03792126. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14222.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.067 | 0.068 |
| Meta-epidemiology (narrow) | 0.006 | 0.004 |
| Meta-epidemiology (broad) | 0.011 | 0.006 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.005 | 0.005 |
| Scholarly communication | 0.006 | 0.004 |
| Open science | 0.005 | 0.003 |
| Research integrity | 0.008 | 0.010 |
| Insufficient payload (model declined to judge) | 0.065 | 0.012 |
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 source (direct Gemma or distilled Codex), 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".