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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Acceptability and deliverability of an auditory rhythmical cueing (ARC) training programme for use at home and outdoors to improve gait and physical activity post-stroke.

BACKGROUND: Although laboratory studies demonstrate that training programmes using auditory rhythmical cueing (ARC) may improve gait post-stroke, few studies have evaluated this intervention in the home and outdoors where deployment may be more appropriate. This manuscript reports stakeholder refinement of an ARC gait and balance training programme for use at home and outdoors, and a study which assessed acceptability and deliverability of this programme. METHODS: Programme design and content were refined during stakeholder workshops involving physiotherapists and stroke survivors. A two-group acceptability and deliverability study was then undertaken. Twelve patients post-stroke with a gait related mobility impairment received either the ARC gait and balance training programme or the gait and balance training programme without ARC. Programme provider written notes, participant exercise and fall diaries, adverse event monitoring and feedback questionnaires captured data about deliverability, safety and acceptability of the programmes. RESULTS: The training programme consisted of 18 sessions (six supervised, 12 self-managed) of exercises and ARC delivered by a low-cost commercially available metronome. All 12 participants completed the six supervised sessions and 10/12 completed the 12 self-managed sessions. Provider and participant session written records and feedback questionnaires confirmed programme deliverability and acceptability. CONCLUSION: An ARC gait and balance training programme refined by key stakeholders was feasible to deliver and acceptable to participants and providers. TRIAL REGISTRATION: ISCTRN 12/03/2018.

Auditory rhythmical cueing to improve gait and physical activity in community-dwelling stroke survivors (ACTIVATE): study protocol for a pilot randomised controlled trial.

BACKGROUND: Mobility problems are present in 70-80% of stroke survivors and can result in impaired gait and reduced physical activity limiting independent living. Auditory rhythmic cueing (ARC) has been used to provide auditory feedback and shows promise in improving a variety of walking parameters following stroke. The aim of this pilot study is to assess the feasibility of conducting a multi-centre, observer blind, randomised controlled trial of auditory rhythmical cueing (ARC) intervention in home and community settings in North East England. METHODS: This pilot observer blind randomised controlled feasibility trial aims to recruit 60 participants over 15 months from community stroke services in the North East of England. Participants will be within 24 months of stroke onset causing new problems with mobility. Each participant will be randomised to the study intervention or control group. Intervention treatment participants will undertake 18 auditory rhythmical cueing (ARC) treatment sessions over 6 weeks (3 × 30 min per week, 6 supervised (physiotherapist/research associate)/12 self-managed) in a home/community setting. A metronome will be used to provide ARC during a series of balance and gait exercises, which will be gradually progressed. The control treatment participants will undertake the same duration balance and gait exercise training programme as the intervention group but without the ARC. Feasibility will be determined in terms of recruitment, retention, adverse events, adherence, collection of descriptive clinical and accelerometer motor performance data at baseline, 6 weeks and 10 weeks and description of participant, provider and clinical therapists' experiences. As well as using questionnaires to collate participant views, qualitative interviews will be undertaken to further understand how the intervention is delivered in practice in a community setting and to identify aspects perceived important by participants. DISCUSSION: The ACTIVATE study will address an important gap in the evidence base by reporting whether it is feasible to deliver auditory rhythmical cueing in the home and community to improve gait and balance parameters following stroke. The feasibility of the study protocol will be established and results will inform the design of a future multi-centre randomised controlled trial. TRIAL REGISTRATION: Trial register: ISRCTN, Trial identifier: ISRCTN10874601: Date of registration: 12/03/2018.

Screening for psychological distress using internet administration of the Hospital Anxiety and Depression Scale (HADS) in individuals with chronic fatigue syndrome.

OBJECTIVES: To investigate the factor structure and internal consistency of the Hospital Anxiety and Depression Scale (HADS) in individuals with Chronic Fatigue Syndrome (CFS) using an Internet administered version of the instrument. DESIGN: Between subjects. METHOD: Confirmatory factor analysis (CFA) and internal consistency analysis of the HADS was used to determine the psychometric characteristics of the instrument in individuals with CFS and a control group with data captured via an Internet data collection protocol. RESULTS: CFA revealed that a 3-factor solution offered the most parsimonious account of the data. Internal consistency estimations of the anxiety and depression subscales were found to be acceptable for both groups. The CFS group was found to have significantly higher HADS-assessed anxiety and depression scores compared with controls, however, there was also evidence found that Internet administration of the instrument may inflate HADS subscale scores as an artifact of testing medium. CONCLUSIONS: The HADS is suitable for use for screening individuals with CFS in terms of the factor structure of the instrument, however, clinicians should be aware that this instrument assesses 3 domains of affective disturbance rather than 2 as is interpreted within the current HADS anxiety and depression subscale scoring system. Researchers need also be aware that Internet administration of negative affective state measures such as the HADS is likely to inflate scores and need to ensure that comparisons between clinical groups are made with control group data gathered using the same collection methodology.

Basal activity of the HPA axis and cognitive function in anorexia nervosa.

Elevated cortisol and cognitive impairments have been described in anorexia nervosa, but the relationship between these two variables has not been adequately explored. We profiled the pattern and extent of the cognitive impairment in anorexia nervosa and determined how this related to cortisol secretion. Twenty patients with anorexia nervosa and a matched control group completed a computerized cognitive assessment battery. Diurnal cortisol secretion was measured by serial saliva sampling. Patients were significantly impaired on tasks of attention, long-term memory and working memory. Both groups showed the expected diurnal variation in cortisol production, but no evidence was found for patient cortisol hypersecretion. No correlation was found between cortisol secretion and any of the cognitive task measures. These data suggest that at least some of the cognitive impairments seen in anorexia nervosa are attributable to something other than a basal increase in cortisol secretion. The limitations of cortisol as an indicator of HPA axis activity are discussed.