Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility

Abstract

ObjectivesTo assess acceptability and feasibility of trial processes and the Rehabilitation Training (ReTrain) intervention including an assessment of intervention fidelity.DesignA two-group, assessor-blinded, randomised controlled trial with parallel mixed methods process and economic evaluations.SettingCommunity settings across two sites in Devon.ParticipantsEligible participants were: 18 years old or over, with a diagnosis of stroke and with self-reported mobility issues, no contraindications to physical activity, discharged from National Health Service or any other formal rehabilitation programme at least 1 month before, willing to be randomised to either control or ReTrain and attend the training venue, possessing cognitive capacity and communication ability sufficient to participate. Participants were individually randomised (1:1) via a computer-generated randomisation sequence minimised for time since stroke and level of functional disability. Only outcome assessors independent of the research team were blinded to group allocation.InterventionsReTrain comprised (1) an introductory one-to-one session; (2) ten, twice-weekly group classes with up to two trainers and eight clients; (3) a closing one-to-one session, followed by three drop-in sessions over the subsequent 3 months. Participants received a bespoke home-based training programme. All participants received treatment as usual. The control group received an exercise after stroke advice booklet.Outcome measuresCandidate primary outcomes included functional mobility and physical activity.ResultsForty-five participants were randomised (ReTrain=23; Control=22); data were available from 40 participants at 6 months of follow-up (ReTrain=21; Control=19) and 41 at 9 months of follow-up (ReTrain=21; Control=20). We demonstrated ability to recruit and retain participants. Participants were not burdened by the requirements of the study. We were able to calculate sample estimates for candidate primary outcomes and test procedures for process and health economic evaluations.ConclusionsAll objectives were fulfilled and indicated that a definitive trial of ReTrain is feasible and acceptable.Trial registration numberNCT02429180; Results.

Influence of Interventions on Daily Physical Activity and Sedentary Behavior after Stroke: A Systematic Review

“…Two of the three studies did not detect between‐group effects on change scores or within‐group effects at post‐intervention . One pilot study reported effect sizes but not statistical significance of change over time on a device‐based measure of total daily physical activity . The only study that conducted follow‐up effects detected no between‐group effects on change scores or within‐group effects .…”

“…Fourteen studies measured changes in step count using a variety of devices . Activity counts were assessed in three studies using the ActiGraph (Actigraph Corp, Pensacola), Sensewear Armband (Body Media, San Francisco), or GENEActiv (ActivInsights, Cambridge) . These devices sample activity counts associated with the user's rate of acceleration, and established cut‐points determine time spent in varying intensities of physical activity.…”

“…Three RCTs examined exercise with behavior change techniques. Two of the three studies did not detect between‐group effects on change scores or within‐group effects at post‐intervention .…”

Independently getting off the floor: a feasibility study of teaching people with stroke to get up after a fall

“…Regaining the capacity to get up from the floor could bring significant functional and psychological benefits to people with stroke, so further research is warranted. A pilot RCT with blinded outcomes assessment has been undertaken to evaluate the acceptability of a rehabilitation programme based on ARNI principles, including the IGO technique (http://clahrc-peninsula.nihr.ac.uk/research/retrain) as well as to check the feasibility of running a definitive RCT (Dean et al, 2018). This will allow us to further assess the safety, benefits and costs of incorporating IGO training within stroke rehabilitation.…”

“…No previous research has evaluated IGO. We therefore conducted an early phase feasibility study to explore its safety, whether it can be taught and how well it works for stroke survivors prior to deciding whether to include IGO in a pilot randomised trial of a rehabilitation programme based on ARNI techniques (Dean, Poltawski, Forster, Taylor, Spencer, James, Allison, Stevens, Norris, Shepherd, Landa, Pulsford, Hollands & Calitri, 2018).…”