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Determining the optimal dose of reactive balance training after stroke: study protocol for a pilot randomised controlled trial.

ABSTRACT: INTRODUCTION:Falls risk poststroke is highest soon after discharge from rehabilitation. Reactive balance training (RBT) aims to improve control of reactions to prevent falling after a loss of balance. In healthy older adults, a single RBT session can lead to lasting improvements in reactive balance control and prevent falls in daily life. While increasing the dose of RBT does not appear to lead to additional benefit for healthy older adults, stroke survivors, who have more severely impaired balance control, may benefit from a higher RBT dose. Our long-term goal is to determine the optimal dose of RBT in people with subacute stroke. This assessor-blinded pilot randomised controlled trial aims to inform the design of a larger trial to address this long-term goal. METHODS AND ANALYSIS:Participants (n=36) will be attending out-patient stroke rehabilitation, and will be randomly allocated to one of three groups: one, three or six RBT sessions. RBT will replace a portion of participants' regular physiotherapy so that the total physical rehabilitation time will be the same for the three groups. Balance and balance confidence will be assessed at: (1) study enrolment; (2) out-patient rehabilitation discharge; and (3) 6 months postdischarge. Participants will report falls and physical activity for 6 months postdischarge. Pilot data will be used to plan the larger trial (ie, sample size estimate using fall rates, and which groups should be included based on between-group trends in pre-to-post training effect sizes for reactive balance control measures). Pilot data will also be used to assess the feasibility of the larger trial (ie, based on the accrual rate, outcome completion rate and feasibility of prescribing specific training doses). ETHICS AND DISSEMINATION:Institutional research ethics approval has been received. Study participants will receive a lay summary of results. We will also publish our findings in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:NCT04219696; Pre results.

SUBMITTER: Mansfield A

PROVIDER: S-EPMC7451480 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Determining the optimal dose of reactive balance training after stroke: study protocol for a pilot randomised controlled trial.

Mansfield Avril A Inness Elizabeth L EL Danells Cynthia J CJ Jagroop David D Bhatt Tanvi T Huntley Andrew H AH

BMJ open 20200826 8

<h4>Introduction</h4>Falls risk poststroke is highest soon after discharge from rehabilitation. Reactive balance training (RBT) aims to improve control of reactions to prevent falling after a loss of balance. In healthy older adults, a single RBT session can lead to lasting improvements in reactive balance control and prevent falls in daily life. While increasing the dose of RBT does not appear to lead to additional benefit for healthy older adults, stroke survivors, who have more severely impai ...[more]

PMID: 32847916

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Project description:IntroductionThe Rehabilitation Training (ReTrain) intervention aims to improve functional mobility, adherence to poststroke exercise guidelines and quality of life for people after stroke. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost-effectiveness of ReTrain, which is based on Action for Rehabilitation from Neurological Injury (ARNI). The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design.Methods and analysisA 2-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed-methods process evaluation and economic evaluation. 48 participants discharged from clinical rehabilitation despite residual physical disability will be individually randomised 1:1 to ReTrain (25 sessions) or control (exercise advice booklet). Outcome assessment at baseline, 6 and 9 months include Rivermead Mobility Index; Timed Up and Go Test; modified Patient-Specific Functional Scale; 7-day accelerometry; Stroke Self-efficacy Questionnaire, exercise diary, Fatigue Assessment Scale, exercise beliefs and self-efficacy questionnaires, SF-12, EQ-5D-5L, Stroke Quality of Life, Carer Burden Index and Service Receipt Inventory. Feasibility, acceptability and process outcomes include recruitment and retention rates; with measurement burden and trial experiences being explored in qualitative interviews (20 participants, 3 intervention providers). Analyses include descriptive statistics, with 95% CI where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis.Ethics and disseminationNational Health Service (NHS) National Research Ethics Service approval granted in April 2015; recruitment started in June. Preliminary studies suggested low risk of serious adverse events; however (minor) falls, transitory muscle soreness and high levels of postexercise fatigue are expected. Outputs include pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised Trainer and Intervention Delivery manuals for multicentre replication of ReTrain; presentations at conferences, public involvement events; internationally recognised peer-reviewed journal publications, open access sources and media releases.Trial registration numberNCT02429180; Pre-results.

Project description:Background:Several studies have reported that using the Wii™ Balance Board can provide added value regarding balance (re-)training in neurological diseases. However, for the large group of mobile older stroke survivors, there is no evidence regarding the feasibility of an unsupervised Wii™ Balance Board training in the home setting. The aim of this study was to investigate the feasibility of a home-based Wii™ balance training for these patients and to identify methodological challenges for randomised controlled trials in the future. Methods:We conducted a pilot randomised controlled trial with two intervention arms in participants' homes. Mobile stroke survivors (aged 60 years or above; 12 weeks after discharge from hospital) received a 6-week (once per week) supervised balance training at the study centre, followed by a 6-week (three times per week) unsupervised balance training at home. We used the Nintendo Wii™ Balance Board for one intervention arm and conventional balance exercises for the other intervention arm. Feasibility was assessed by recruiting rates, appropriateness of assessments regarding sensitivity to changes and acceptance of the intervention by the participants. Results:In two German hospital stroke units, 349 stroke survivors were screened over a period of 6 months, 91 were eligible and 52 were interested. Twelve weeks after discharge, 14 participants agreed and 11 completed the intervention (7 men and 4 women, mean age 74 years). The Berg Balance Scale and Dynamic Gait Index showed ceiling effects already at baseline measure. The participants in both intervention arms evaluated the unsupervised training positively and feasible for self-application. No falls or injuries occurred over the intervention period, while the required scope of the exercises could largely be achieved. Conclusions:In this pilot study, the recruitment of participants and the chosen assessments were not satisfactory due to selection bias and corresponding ceiling effects. However, the two home-based balance interventions proved feasible for mobile older stroke survivors with low functional limitations. Trial registration:ClinicalTrials.gov, NCT02251470. Registered 29 September 2014.

Project description:IntroductionPerturbation-based balance training (PBT) targets the mechanism of falls (eg, slipping, tripping) to specifically train the recovery actions needed to avoid a fall. This task-specific training has shown great promise as an effective and efficient intervention for fall prevention in older adults. However, knowledge about the dose-response relationship of PBT, as well as its feasibility and acceptability in older adults with increased risk of falling is still limited. Thus, the aim of this study is to compare the effectiveness of two different treadmill PBT protocols for improving reactive balance control in fall-prone older adults, and to evaluate the feasibility and acceptability of these protocols.Methods and analysisThe study is designed as a pilot randomised controlled trial with a 6-week intervention and 6-week follow-up period. Thirty-six community-dwelling, fall-prone (Timed Up and Go >12 s, habitual gait speed <1.0 m/s and/or fall history) older adults will be randomised (1:1) to receive six (weeks 1-6) or two treadmill PBT sessions (weeks 1+6) plus four conventional treadmill training sessions (weeks 2-5). Training sessions are conducted 1×/week for 30 min. Each PBT will include 40 perturbations in anterior-posterior and mediolateral directions. Reactive balance after perturbations in standing (Stepping Threshold Test (STT)) and walking (Dynamic Stepping Threshold Test (DSTT)) will be assessed as the primary outcome for effectiveness. Secondary outcomes are spatiotemporal and kinematic parameters collected during STT, DSTT and PBT, maximum perturbation magnitude for each PBT session, static and dynamic balance, physical capacity, physical activity, concerns with falling and executive functions. Feasibility will be assessed via training adherence, drop-out rate, perturbations actually performed and adverse events; and acceptability via self-designed questionnaire and focus groups.Ethics and disseminationThe study has been approved by the Ethics Committee of the Medical Faculty Heidelberg (S-602/2022). Findings will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numberDRKS00030805.

Project description:IntroductionDespite of recent advancement in the burns wound management, burn wound infection (BWI) is still one of the major cause of burns mortality. Patients who survive their burns injury still suffers from BWI related complication like delayed wound healing and poor scarring. BWI has been treated by application of topical antimicrobial agents or systemic antibiotics. Due to the global risk of developing systemic antibiotics resistance, medical research focuses on identifying single topical agent which has effective antimicrobial activity, easily available and cost effective. One such agent is acetic acid (AA). AA has been used as a topical antibacterial agent for the treatment of burns wounds for many years and has shown to have activity against gram-negative organisms including Pseudomonas aeruginosa. So far there has been no consensus on optimal concentration that has effective antimicrobial activity, frequency of application, duration of treatment and most importantly good patient's tolerability. A randomised control study is required to answer all these questions.ObjectiveTo investigate the efficacy and tolerability of 0.5% and 2% of AA when applied to colonised burns wounds for 3 days after admittance to the Queen Elizabeth Hospital Birmingham.Methods and analysisThis is a double-blinded, prospective, randomised, controlled, single-centre trial. Patients will be screened for eligibility in the inpatient area and those who are found to be eligible will be randomly assigned to one of two treatment groups: group 1: 0.5% AA (10 patients); group 2: 2% AA (10 patients); total number: 20 patients.Outcome measuresPrimary outcome: Efficacy will be assessed by measuring the bacterial load from microbiology wound swabs for three consecutive days.Secondary outcomes: (1) The assessment of antimicrobial activity of AA and the minimum inhibitory concentrations. (2) Patient's tolerance by assessing Visual Analogue Scale pain score. (3) Time to 95% wound healing of treatment area. (4) Patient's perceived treatment allocation.Ethics and disseminationAceticA trial protocol was approved by the National Research Ethics Service (West Midlands-Edgbaston Research Ethics Committee; 17/WM/0407; IRAS 234132). This article refers to protocol version 5.0 dated 6 July 2020. The analysed results will be presented at national and international conferences related to management of burn patients. The generated articles based on the trial results will be submitted to peer review journals for publication.Trial registration numberISRCTN11636684.

Project description:BACKGROUND:Given the rising number of strokes worldwide, and the large number of individuals left with disabilities after stroke, novel strategies to reduce disability, increase functions in the motor and the cognitive domains, and improve quality of life are of major importance. Physical activity is a promising intervention to address these challenges but, as yet, there is no study demonstrating definite outcomes. Our objective is to assess whether additional treatment in the form of physical fitness-based training for patients early after stroke will provide benefits in terms of functional outcomes, in particular gait speed and the Barthel Index (co-primary outcome measures) reflecting activities of daily living (ADL). We will gather secondary functional outcomes as well as mechanistic parameters in an exploratory approach. METHODS/DESIGN:Our phase III randomised controlled trial will recruit 215 adults with moderate to severe limitations of walking and ADL 5 to 45 days after stroke onset. Participants will be stratified for the prognostic variables of "centre", "age", and "stroke severity", and randomly assigned to one of two groups. The interventional group receives physical fitness training delivered as supported or unsupported treadmill training (cardiovascular active aerobic training; five times per week, over 4 weeks; each session 50 minutes; total of 20 additional physical fitness training sessions) in addition to standard rehabilitation treatment. The control intervention consists of relaxation sessions (non-cardiovascular active; five times per week week, over 4 weeks; each session 50 minutes) in addition to standard rehabilitation treatment. Co-primary efficacy endpoints will be gait speed (in m/s, 10 m walk) and the Barthel Index (100 points total) at 3 months post-stroke, compared to baseline measurements. Secondary outcomes include standard measures of quality of life, sleep and mood, cognition, arm function, maximal oxygen uptake, and cardiovascular risk factors including blood pressure, pulse, waist-to-hip ratio, markers of inflammation, immunity and the insulin-glucose pathway, lipid profile, and others. DISCUSSION:The goal of this endpoint-blinded, phase III randomised controlled trial is to provide evidence to guide post-stroke physical fitness-based rehabilitation programmes, and to elucidate the mechanisms underlying this intervention. TRIAL REGISTRATION:Registered in ClinicalTrials.gov with the Identifier NCT01953549.

Project description:OBJECTIVES:No intervention has been shown to prevent falls poststroke. We aimed to determine if perturbation-based balance training (PBT) can reduce falls in daily life among individuals with chronic stroke. DESIGN:Assessor-blinded randomised controlled trial. SETTING:Two academic hospitals in an urban area. INTERVENTIONS:Participants were allocated using stratified blocked randomisation to either 'traditional' balance training (control) or PBT. PBT focused on improving responses to instability, whereas traditional balance training focused on maintaining stability during functional tasks. Training sessions were 1 hour twice/week for 6 weeks. Participants were also invited to complete 2 'booster' training sessions during the follow-up. PARTICIPANTS:Eighty-eight participants with chronic stroke (>6 months poststroke) were recruited and randomly allocated one of the two interventions. Five participants withdrew; 42 (control) and 41 (PBT group) were included in the analysis. PRIMARY AND SECONDARY OUTCOME MEASURES:The primary outcome was rate of falls in the 12 months post-training. Negative binomial regression was used to compare fall rates between groups. Secondary outcomes were measures of balance, mobility, balance confidence, physical activity and social integration. RESULTS:PBT participants reported 53 falls (1.45 falls/person-year) and control participants reported 64 falls (1.72 falls/person-year; rate ratio: 0.85(0.42 to 1.69); p=0.63). Per-protocol analysis included 32 PBT and 34 control participants who completed at least 10/12 initial training sessions and 1 booster session. Within this subset, PBT participants reported 32 falls (1.07 falls/person-year) and control participants reported 57 falls (1.75 falls/person-year; rate ratio: 0.62(0.29 to 1.30); p=0.20). PBT participants had greater improvement in reactive balance control than the control group, and these improvements were sustained 12 months post-training. There were no intervention-related serious adverse effects. CONCLUSIONS:The results are inconclusive. PBT may help to prevent falls in daily life poststroke, but ongoing training may be required to maintain the benefits. TRIAL REGISTRATION NUMBER:ISRCTN05434601; Results.

Project description:BackgroundLarge studies have shown that stroke is among the most relevant causes of acquired adult disability. Walking and balance impairment in stroke survivors often contribute to a restriction in daily activities and social participation. Task-oriented training (TOT) is an effective treatment strategy and manual therapy (MT) is used successfully to enhance ankle joint flexibility in this population. No study, however, has compared TOT against its combination with MT in a randomised controlled trial. Aims of this pilot study are therefore to explore the feasibility of a full-scale RCT using predefined feasibility criteria. Secondary aims are to explore the preliminary effects of specific TOT with a combined specific TOT-MT versus a control group in people post stroke.MethodsThis is a protocol of a 4-week prospective randomised controlled parallel pilot trial in people post stroke at the chronic stage with limited upper ankle joint mobility and an impairment in balance and mobility. At a German outpatient therapy centre using 1:1:1 allocation, 36 patients will be randomised into one of three groups: 15-min talocrural joint MT plus 30-min specific TOT (group A), 45-min specific TOT (group B), and controls (group C). Training will be goal-oriented including tasks that are based on daily activities and increased in difficulty utilising predefined progression criteria based on patients' skill levels. Interventions will be provided face-to-face 2 times per week, for 4 weeks, in addition to 20-min concurrent x4 weekly home-based training sessions. Data will be collected by blinded assessors at baseline, post-intervention and 4-week follow-up. The primary outcome will be feasibility assessed by recruitment, retention and adherence rates, compliance, adverse events, falls and the acceptability of the intervention. Secondary outcomes will be walking speed, single and dual tasking functional mobility, ankle range of motion, disability and health-related quality of life.DiscussionFeasibility provided, results from this study will be used to calculate the sample size of a larger randomised controlled trial to investigate the effects of specific TOT and specific TOT-MT compared to a post stroke control group.Trial registrationGerman Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068 .

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Determining the optimal dose of reactive balance training after stroke: study protocol for a pilot randomised controlled trial.

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Determining the optimal dose of reactive balance training after stroke: study protocol for a pilot randomised controlled trial.

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