Auditory rhythmical cueing to improve gait in community-dwelling stroke survivors (ACTIVATE): a pilot randomised controlled trial

Shaw, Lisa, McCue, Patricia, Brown, Philip, Buckley, Christopher, Del Din, Silvia, Francis, Richard, Hunter, Heather, Lambert, Allen, Lord, Sue, Price, Christopher I. M., Rodgers, Helen, Rochester, Lynn and Moore, Sarah (2022) Auditory rhythmical cueing to improve gait in community-dwelling stroke survivors (ACTIVATE): a pilot randomised controlled trial. Pilot and Feasibility Studies, 8 (1). p. 239. ISSN 2055-5784

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Gait impairment limiting mobility and restricting activities is common after stroke. Auditory rhythmical cueing (ARC) uses a metronome beat delivered during exercise to train stepping and early work reports gait improvements. This study aimed to establish the feasibility of a full scale multicentre randomised controlled trial to evaluate an ARC gait and balance training programme for use by stroke survivors in the home and outdoors.

A parallel-group observer-blind pilot randomised controlled trial was conducted. Adults within 2 years of stroke with a gait-related mobility impairment were recruited from four NHS stroke services and randomised to an ARC gait and balance training programme (intervention) or the training programme without ARC (control). Both programmes consisted of 3x30 min sessions per week for 6 weeks undertaken at home/nearby outdoor community. One session per week was supervised and the remainder self-managed. Gait and balance performance assessments were undertaken at baseline, 6 and 10 weeks. Key trial outcomes included recruitment and retention rates, programme adherence, assessment data completeness and safety.

Between November 2018 and February 2020, 59 participants were randomised (intervention n=30, control n=29), mean recruitment rate 4/month. At baseline, 6 weeks and 10 weeks, research assessments were conducted for 59/59 (100%), 47/59 (80%) and 42/59 (71%) participants, respectively. Missing assessments were largely due to discontinuation of data collection from mid-March 2020 because of the UK COVID-19 pandemic lockdown. The proportion of participants with complete data for each individual performance assessment ranged from 100% at baseline to 68% at 10 weeks. In the intervention group, 433/540 (80%) total programme exercise sessions were undertaken, in the control group, 390/522 (75%). Falls were reported by five participants in the intervention group, six in the control group. Three serious adverse events occurred, all unrelated to the study.

We believe that a definitive multicentre RCT to evaluate the ARC gait and balance training programme is feasible. Recruitment, programme adherence and safety were all acceptable. Although we consider that the retention rate and assessment data completeness were not sufficient for a future trial, this was largely due to the UK COVID-19 pandemic lockdown.

Trial registration
ISRCTN, ISRCTN10874601, Registered on 05/03/2018,

Item Type: Article
Additional Information: Funding information: This study was funded by The Stroke Association, reference TSA 2016/06. SAM was supported by Health Education England and the National Institute for Health Research (HEE/NIHR ICA Programme Clinical Lectureship, Dr Sarah Anne Moore, ICA-CL-2015-01-012). SDD and LR are supported by the Newcastle Biomedical Research Centre (BRC) based at Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University. The work was also supported by the NIHR/Wellcome Trust Clinical Research Facility (CRF) infrastructure at Newcastle upon Tyne Hospitals NHS Foundation Trust. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care or the funders. The funders had no role in the study design, data collection, analysis, interpretation or writing this manuscript.
Uncontrolled Keywords: Stroke, Gait, Exercise, Rehabilitation, Auditory rhythmical cueing, Pilot randomized controlled trial
Subjects: B900 Others in Subjects allied to Medicine
C600 Sports Science
Department: Faculties > Health and Life Sciences > Sport, Exercise and Rehabilitation
Depositing User: Elena Carlaw
Date Deposited: 09 Dec 2022 14:50
Last Modified: 09 Dec 2022 15:00

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