Dataset Information

Innovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol.

ABSTRACT:

Introduction

The STRoke Interactive Virtual thErapy (STRIVE) intervention provides community-dwelling stroke survivors access to individualised, remotely supervised progressive exercise training via an online platform. This trial aims to determine the clinical efficacy of the STRIVE intervention and its effect on brain activity in community-dwelling stroke survivors.

Methods and analysis

In a multisite, assessor-blinded randomised controlled trial, 60 stroke survivors >3 months poststroke with mild-to-moderate upper extremity impairment will be recruited and equally randomised by location (Melbourne, Victoria or Launceston, Tasmania) to receive 8 weeks of virtual therapy (VT) at a local exercise training facility or usual care. Participants allocated to VT will perform 3-5 upper limb exercises individualised to their impairment severity and preference, while participants allocated to usual care will be asked to maintain their usual daily activities. The primary outcome measures will be upper limb motor function and impairment, which will be assessed using the Action Research Arm Test and Upper Extremity Fugl-Meyer, respectively. Secondary outcome measures include upper extremity function and spasticity, as measured by the box and block test and Modified AshworthScale, respectively, and task-related changes in bilateral sensorimotor cortex haemodynamics during hand reaching and wrist extension movements as measured by functional near-infrared spectroscopy. Quality of life will be measured using the Euro-Quality of Life-5 Dimension-5 Level Scale, and the Motor Activity Log-28 will be used to measure use of the hemiparetic arm. All measures will be assessed at baseline and immediately postintervention.

Ethics and dissemination

The study was approved by the Deakin University Human Research Ethics Committee in May 2017 (No. 2017-087). The results will be disseminated in peer-reviewed journals and presented at major international stroke meetings.

Trial registration number

ACTRN12617000745347; Pre-results.

SUBMITTER: Johnson L

PROVIDER: S-EPMC5781224 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Publications

Innovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol.

Johnson Liam L Bird Marie-Louise ML Muthalib Makii M Teo Wei-Peng WP

BMJ open 20180109 1

<h4>Introduction</h4>The STRoke Interactive Virtual thErapy (STRIVE) intervention provides community-dwelling stroke survivors access to individualised, remotely supervised progressive exercise training via an online platform. This trial aims to determine the clinical efficacy of the STRIVE intervention and its effect on brain activity in community-dwelling stroke survivors.<h4>Methods and analysis</h4>In a multisite, assessor-blinded randomised controlled trial, 60 stroke survivors >3 months po ...[more]

PMID: 29317414

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Project description:BackgroundStroke survivors constantly feel helpless and unprepared after discharge from hospitals. More flexible and pragmatic support are needed for their optimized recovery. We examined the effects of a virtual multidisciplinary stroke care clinic on survivors' health and self-management outcomes.MethodsA randomized controlled trial was conducted. Survivors were recruited from 10 hospitals and randomized at 1:1 ratio into the intervention or the control groups. Intervention group participants received the Virtual Multidisciplinary Stroke Care Clinic service (monthly online consultations with a nurse, follow-up phone calls, and access to an online platform). Control group participants received the usual care. Outcomes of self-efficacy (stroke self-efficacy questionnaire; primary), self-management behaviors (Stroke Self-Management Behaviors Performance Scale), social participation (reintegration to normal living index), and depression (Geriatric Depression Scale; secondary) were measured at baseline, and 3 and 6 months after commencing the intervention (post-randomization). A generalized estimating equations model was used to compare the differential changes in outcomes at 3 and 6 months with respect to baseline between 2 groups.ResultsBetween July 2019 and June 2022, 335 eligible participants were enrolled in the study. Participants (intervention group; n=166) showed significantly greater improvements in outcomes of self-efficacy (group-by-time interaction regression coefficient, B=4.60 [95% CI, 0.16 to 9.05]), social participation (B=5.07 [95% CI, 0.61 to 9.53]), and depression (B=-2.33 [95% CI, -4.06 to -0.61]), and no significant improvement in performance of self-management behaviors (B=3.45, [95% CI, -0.87 to 7.77]), compared with the control group (n=169) right after the intervention (6 months after its commencement). Hedges' g effect sizes of the intervention on outcomes: 0.19 to 0.36.ConclusionsThe results provide some positive evidence on the usefulness of the Virtual Multidisciplinary Stroke Care Clinic service. The effect sizes are regarded as small to medium, which may not be of clinical relevance. The baseline levels in outcomes were in favor of the control group, the intervention effects might be overestimated. The service must be tested further to determine its effectiveness.RegistrationURL: https://www.chictr.org.cn; Unique identifier: ChiCTR1800016101.

Project description:IntroductionThe virtual multidisciplinary stroke care clinic (VMSCC) is the first nurse-led clinic developed to offer support to community-dwelling stroke survivors and caregivers, and to promote poststroke recovery. This two-arm randomised controlled trial will evaluate its effectiveness on survivors' self-efficacy (SE), survivors' and caregivers' health-related quality of life (HRQoL) and cost-effectiveness on emergency admissions and length of readmission hospital stay.Methods and analysisA consecutive sample of 384 stroke survivor-caregiver dyads will be recruited from four hospitals. An online platform that embraces readily accessible and reliable information will be developed. Participants randomly assigned to the intervention group will receive usual care plus the VMSCC service. The service includes access to a tablet containing 30 videos demonstrating appropriate self-care strategies, communication with a registered nurse monthly through video and telephone calls and regular blood pressure monitoring. Primary outcomes include survivors' SE in self-management and survivors' and caregivers' HRQoL. Secondary outcomes include survivors' performance of self-management behaviours, depression and social participation; and caregivers' coping strategies, satisfaction with caring and depression. Data will be collected at baseline, and at 3 and 6 months after commencing the intervention. Survivors' and caregivers' satisfaction with the service will be assessed at 6-month follow-up. Multivariable regressions and generalised estimating equations model will be conducted. Survivors' emergency admissions and length of hospital stay will be evaluated during the 6-month follow-up period. Cost-effectiveness analysis will be performed on the average total cost incurred.DiscussionThe results will inform stakeholders about incorporating the VMSCC service into current stroke rehabilitation service.Ethics and disseminationThis protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2017.660). All participants will provide written informed consent. Results will be disseminated through scientific publications, and presentations at local and international conferences.Trial registration numberChiCTR1800016101; Pre-results.

Project description:IntroductionStudies show that stroke survivors encounter physical and psychological limitations that restrict their participation in social and community activities. Systematic reviews have yielded inconclusive evidence regarding the effectiveness of different interventions intended to support stroke survivors' social participation. Recent advances in virtual reality technology may offer promising solutions, although the optimal approach to enhance social participation among stroke survivors is yet to be determined. This trial aims to develop and evaluate the effectiveness of a social participation-focused virtual reality (SP-VR) intervention on the physical, psychological and social outcomes of community-dwelling stroke survivors with physical disabilities.Methods and analysisA two-arm randomised, controlled, assessor-blind clinical trial will be conducted with 250 stroke survivor-caregiver dyads recruited from three acute and one rehabilitation hospitals, and three stroke nurse-led clinics. Participants will be survivors of a first or recurrent stroke within 6 months of stroke onset and able to remain in a sitting position without support, and their primary caregivers. Eligible participants will be randomly allocated to receive the SP-VR intervention or usual care which includes conventional physical therapy services. The intervention group will receive a newly developed 6-week novel custom-made SP-VR application comprising two sessions weekly. Three SP-VR modules will cover key aspects of survivors' social health needs, namely functional rehabilitation, social participation, and social interaction and recreation. The primary outcome for stroke survivors is social participation, and secondary outcomes include depressive symptoms, participation self-efficacy, physical function, functional mobility and social support. User satisfaction will be evaluated among both survivors and caregivers. Data will be collected in person at baseline, immediately after, and 3 months postintervention.Ethics and disseminationEthical approval has been obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Research Ethics Committee (Ref. No.: 2019.676). Study results will be disseminated through peer-reviewed journals and conference presentations.Trial registration numberChiCTR2100050850.

Project description:BackgroundGait 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.MethodsA 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.ResultsBetween 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.ConclusionWe 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 registrationISRCTN, ISRCTN10874601 , Registered on 05/03/2018.

Project description:BackgroundThe aim of this trial was to evaluate the effectiveness of an online health behaviour change intervention-Prevent 2nd Stroke (P2S)-at improving health-related quality of life (HRQoL) amongst stroke survivors at 6 months of follow-up.Methods and findingsA prospective, blinded-endpoint randomised controlled trial, with stroke survivors as the unit of randomisation, was conducted between March 2018 and November 2019. Adult stroke survivors between 6 and 36 months post-stroke with capacity to use the intervention (determined by a score of ≥4 on the Modified Rankin Scale) and who had access and willingness to use the internet were recruited via mail-out invitations from 1 national and 1 regional stroke registry. Participants completed baseline (n = 399) and 6-month follow-up (n = 356; 89%) outcome assessments via computer-assisted telephone interviewing (CATI). At baseline the sample had an average age of 66 years (SD 12), and 65% were male. Randomisation occurred at the end of the baseline survey; CATI assessors and independent statisticians were blind to group allocation. The intervention group received remote access for a 12-week period to the online-only P2S program (n = 199; n = 28 lost at follow-up). The control group were emailed and posted a list of internet addresses of generic health websites (n = 200; n = 15 lost at follow-up). The primary outcome was HRQoL as measured by the EuroQol Visual Analogue Scale (EQ-VAS; self-rated global health); the outcome was assessed for differences between treatment groups at follow-up, adjusting for baseline measures. Secondary outcomes were HRQoL as measured by the EQ-5D (descriptive health state), diet quality, physical activity, alcohol consumption, smoking status, mood, physical functioning, and independent living. All outcomes included the variable 'stroke event (stroke/transient ischaemic attack/other)' as a covariate, and analysis was intention-to-treat. At 6 months, median EQ-VAS HRQoL score was significantly higher in the intervention group than the control group (85 vs 80, difference 5, 95% CI 0.79-9.21, p = 0.020). The results were robust to the assumption the data were missing at random; however, the results were not robust to the assumption that the difference in HRQoL between those with complete versus missing data was at least 3 points. Significantly higher proportions of people in the intervention group reported no problems with personal care (OR 2.17, 95% CI 1.05-4.48, p = 0.0359) and usual activities (OR 1.66, 95% CI 1.06-2.60, p = 0.0256) than in the control group. There were no significant differences between groups on all other secondary outcomes. The main limitation of the study is that the sample comprises mostly 'well' stroke survivors with limited to no disability.ConclusionsThe P2S online healthy lifestyle program improved stroke survivors' self-reported global ratings of HRQoL (as measured by EQ-VAS) at 6-month follow-up. Online platforms represent a promising tool to engage and support some stroke survivors.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12617001205325.

Dataset Information

Innovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Innovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol.

Similar Datasets

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