JMIR Publications

ABSTRACT

Background:

Whilst 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 (e.g. reduced quantity feedback or an external focus of attention), within controlled environments. These studies predominantly evaluate performance, with few measuring this over time (i.e. learning). The relevance and transferability of current research evidence into stroke rehabilitation is therefore unknown.

Objective:

To assess the feasibility of running a cluster randomised trial of an implicit learning approach (ILA) versus usual care for functional motor recovery in the acute phase following stroke.

Methods:

This is a multicentre, assessor blind, cluster randomised controlled pilot trial, with nested qualitative evaluation. Stroke Units (clusters) will be randomised 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 take place at the individual participant level. Once enrolled, participants will receive all rehabilitation that focusses on lower limb recovery, using the designated approach. Measures will be taken at baseline, every two weeks until the point of discharge from hospital, and at three months post stroke onset. Measures include the Fugl Meyer Assessment (motor leg sub-section), 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. Parameters relating to the overall design will be estimated, and used to inform a future trial (e.g. recruitment and retention). 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. Opening of a further 5 sites will be staggered throughout 2019.

Conclusions:

The findings from this mixed methods pilot study will be used to inform the design of a definitive study, comparing the ILA to standard care in acute stroke rehabilitation. ts are expected in early 2021. Clinical Trial: The study has been approved by the Berkshire Research Ethics Committee B [18/SC/0582]. Registered on ClinicalTrials.gov [NCT03792126]