Refinement of a prototype ARC programme

Literature on the content and dose of promising previous stroke ARC gait and balance programmes informed the development of a prototype programme. [12, 13, 15]. This programme and the related materials were taken to stakeholder workshops to refine content. The participating stakeholders were physiotherapists working in stroke services and stroke survivors. Workshop participants were asked to review the programme and materials for utility and quality of content. Materials included low-cost commercially available metronomes, examples of potential exercise handouts, and a video which showed how to operate a metronome and its use during balance and gait exercises. Verbal discussions were held about the materials with notes taken by a study team attendee, and participants also completed a series of 5-point Likert scale questions (1 ‘strongly disagree’ to 5 ‘strongly agree’) which are shown in the Supplementary Materials Appendix A. At the stakeholder workshops, physiotherapists were also asked to provide additional verbal feedback about aspects of the future acceptability and deliverability study design. The workshops were video recorded.

Following the stakeholder workshops, the video recordings were reviewed with the written notes taken during the sessions and a summary of findings created. Responses to Likert scale questions were collated. Data were used to refine the content of the ARC gait and balance training programme and inform aspects of the acceptability and deliverability study design.

Acceptability and deliverability study

Study design, sample size and setting

A two-group acceptability and deliverability study was conducted. Group one received the developed ARC gait and balance training programme. Group two received the gait and balance training programme but without ARC. This design was chosen to reflect the planned future pilot randomized controlled trial where the gait and balance training programme without ARC would be the control group. The pre-specified sample size was 12 participants and a simple group allocation process was used. The first eight enrolled participants were allocated to group one and the second four participants to group two. The sample size of 12 participants was selected to allow small scale exploration of both programmes before a larger appropriately sized pilot trial. A greater number of participants were allocated to group one because ARC gait and balance training following stroke is relatively novel therefore may be less acceptable/deliverable, whereas gait and balance programmes without ARC are commonly delivered in the home and community in clinical practice. Participants were recruited from two NHS community stroke services in the North East of England. The training programmes were delivered in the participants’ homes and outdoors.

Participants

Community dwelling adults within 24 months of stroke (first ever or recurrent) who could walk independently for more than 10 m (with or without a stick) indoors but had a gait-related mobility impairment resulting from their stroke were eligible. Gait-related mobility impairments were based on the routine clinical observation of NHS professionals who identified patients to take part in the study or patient self-report including: e.g. gait asymmetry, reduced walking speed, reduced balance, reduced walking confidence.

Individuals were excluded if they were currently undertaking any active physiotherapy, had other neurological or orthopaedic conditions affecting gait (e.g. Parkinson’s disease, rheumatoid arthritis) or if they had any diagnosis likely to interfere with adherence to training or which predisposed to falls (e.g. uncorrected hearing problems, registered blind). In addition, individuals unlikely to be able to follow study procedures due to cognitive impairment or communication difficulties were also excluded. All participants provided written informed consent. London – City and East Research Ethics Committee granted ethical approval for this study (REF 18/LO/0115, 12th January 2018).

Group one: ARC gait and balance training programme

Table 1 provides a summary description of the ARC gait and balance training programme using the Template for Intervention Description and Replication (TIDieR) framework [16].

Table 1 Description of the ARC gait and balance training programme using TIDieR framework

The programme consisted of three 30-min training sessions per week for 6 weeks (total 18 sessions) undertaken in home and outdoor settings. This dose and duration was selected based on findings from previous cueing studies in stroke delivered in the laboratory, on the ward and in the home [17], and Parkinson’s disease literature [18].

ARC was provided with either a commercially available metronome (Metro Tuner MT-100 by Musedo) or a free metronome app for a mobile phone: ‘ZyMi’ for android or ‘Pro Metronome’ for iOS. Participant preference led the choice of metronome. The frequency of the auditory cue depended on the type of training and the auditory cue had a regular pattern. A single tone rather than separate tones to cue each leg was used as this approach has been found to be most preferable for stroke patients and is more likely to aid compliance if used as a training tool in rehabilitation [19]. A total of 10 gait and balance exercises were used with ARC. Examples include ‘weight shifting from side-to-side’ and ‘maneuvering between objects’ (documentation shown in Supplementary Materials Appendix B). Exercises were gradually progressed according to the patient’s ability by increasing the speed/intensity, duration or amount.

One training session per week was supervised by a provider from the study team (PM: stroke researcher with a background in psychology or HH: research physiotherapist with stroke specialist skills and over 20 years of clinical experience) and the other two sessions were self-managed. During the supervised sessions, the study provider taught the participant the ARC gait and balance exercises and selected the frequency for the auditory cue during each exercise. During self-managed sessions, participants enacted the exercises that they had been taught in the supervised sessions. Participants were also provided with a paper training manual which included illustrations and descriptions of the exercises to be undertaken. In addition, videos of exercises were available online.

During weeks 4–6, the supervised session focused on walking outdoors. In these sessions, the metronome frequency was initially set at the participant’s self-selected stepping frequency. This is potentially the most effective method of cueing in stroke [20].

Standardising and assessing programme deliverability, and reporting adherence were important aspects of this study and several methods were incorporated into the programme design to address this. The two providers received face-to-face training from the programme lead (highly specialised stroke physiotherapist and clinical academic) in advance of the study start. The study lead also observed each of the providers delivering the programme to one participant to confirm correct delivery. Furthermore, both providers attended all sessions for the first four participants to observe each other and provide feedback about appropriate delivery. During supervised sessions, providers made written notes about session content including exercise enactment, progression and session duration. To check that participants were completing the self-management aspects of the programme as intended, providers asked for a description and demonstration of what had been undertaken and provided participants with feedback as required. Providers also made notes about participant use of study materials including paper exercise instructions and videos, and metronome preferences. Participants were asked to record session completion in a diary section within the issued paper-training manual.

Group two: gait and balance training programme without ARC

Participants in group two undertook the gait and balance training programme without ARC. The dose, duration, mode of delivery, exercises, materials (excluding ARC or reference to ARC) and records maintained were identical to group one. At supervised sessions, participants were given basic instructions about exercises but no cues of an auditory nature e.g. any verbal timing cues.

Data collection

Participant demography, stroke characteristics, gait performance and other health parameters were recorded on enrolment into the study. These included: sex; age; pre-stroke walking status (with/without stick); pre-stroke disability (Modified Rankin Scale) [21]; stroke type and subtype; time since stroke; current stroke impairment (National Institute of Health Stroke Scale) [22] and disability (Modified Rankin Scale) [21]; walking aid use; ankle foot orthosis use; walking speed (average speed measured over five × 4 m trials with/without stick at self-selected pace, 4 m walk selected because this distance was feasible for measurements in participants homes); current cognitive function (Montreal Cognitive Assessment) [23]; mood (Physical Health Questionnaire-9) [24] and fatigue (Fatigue Assessment Scale), [25].

The following data were collected during or at the end of each participant’s involvement in the study to determine acceptability and deliverability:

  1. 1.

    ARC and/or gait and balance training programme delivery

Data recorded included provider written notes about face-to-face sessions and the participant’s self-completion session diary.

  1. 2.

    Safety including falls

Researchers collected data about any adverse and serious adverse event using standard definitions. To collect data about falls, participants were issued with a study designed falls diary which they were asked to complete applying a standard definition for a fall [26]. Providers of the study training programmes checked that participants were maintaining their falls diary and assisted with completion if required.

  1. 3.

    Participant and provider feedback about ARC and/or gait and balance training

Participants and providers of the ARC and/or gait and balance training programmes completed questionnaires developed for the study. Responses to questions were captured on a 5-point Likert Scale (1 ‘strongly disagree’ to 5 ‘strongly agree’). Participant questions included ease of participating in the study and ARC and/or gait and balance training, and were informed by questions used in a previous feasibility study [27]. Provider questions covered the content of the ARC and/or gait and balance training programme including duration of sessions, exercises and available materials. Providers could also provide additional free text comments about aspects of the programme. Providers completed a separate questionnaire after delivery of the training programme to each individual participant.

Data analysis

Quantitative data are reported descriptively. Free text data were examined and summarised.

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