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Background: Elderly people represent the majority of stroke cases worldwide. Post-stroke sequelae frequently lead to a more isolated life. Restricted social relations render older individuals with stroke a vulnerable group, especially in terms of social reintegration. Reintegration into the community after a stroke largely depends on support from the family. However, close relatives are at risk of becoming overburdened. The aim of this study is to investigate the effect of a novel self-management intervention to support elderly people after stroke.Methods/design: Randomized controlled trial. Two weeks before discharge from a rehabilitation hospital/center, individuals with stroke aged > 65 years will be randomized either to a group receiving conventional neurorehabilitation (control) or to an additional novel self-management intervention. In the intervention group, patients with stroke will be offered eight self-management sessions of 45-60 min duration by a physiotherapist or an occupational therapist during a period of nine months after discharge. Inclusion will continue until at least 35 individuals in each group have been recruited. Study outcome measurements: Stroke Self-efficacy Questionnaire, a short version of Stroke Specific Quality of Life Scale, Impact on Participation and Autonomy and Caregiver Burden Scale. Furthermore, physical activity will be assessed using accelerometers. All outcomes except "impact on participation" and "autonomy" will be assessed at baseline, three months, and nine months after discharge. Impact on participation and autonomy will be assessed at three and nine months after discharge. Patient, informal caregiver, and therapist satisfaction will be examined by way of questionnaires and interviews.Discussion: Self-management interventions are promising strategies for rehabilitation, potentially increasing self-efficacy, quality of life, as well as participation and autonomy. The introduction of a novel self-management intervention in combination with traditional physical and occupational therapy may enhance recovery after stroke and quality of life and lessen the burden on relatives. This trial "Stroke - 65 Plus. Continued Active Life," will provide further evidence of self-management strategies to clinicians, patients, and health economists.Trial Registration: ClinicalTrials.gov, NCT03183960 . Registered on 12 June 2017. [ABSTRACT FROM AUTHOR]

Background: A good portion of stroke patients in Western countries are over 65 of age. Because of sequelae, they often lead more isolated lives after the stroke. In terms of social reintegration, this group of patients is especially vulnerable. Reintegration into the community post-stroke greatly depends on support from family. However, the stroke individual's closest relatives are at risk of becoming overburdened. The objectives are to describe the social psychological mechanisms and processes involved in a novel self-management intervention, and to evaluate their feasibility and acceptability from the stroke individuals', the informal caregivers' and the mentors' perspectives, before implementation into a randomised controlled trial.Methods: Qualitative interviews were conducted and analysed using a phenomenological approach. Informants comprised four stroke individuals, three informal caregivers and two mentors. The UK Medical Research Council Framework for developing and evaluating complex interventions was used in the evaluation design of the intervention.Results: Six social psychological mechanisms were revealed as the mentors' focus areas in their interaction with stroke individuals and informal caregivers: a) Tailored approach - by individual preferences, b) Dialogue-based communication, c) Development of a good relationship, d) Transfer of activities to everyday and social contexts, e) Involvement of relatives and social networks, and f) Supporting tools - to optimise actions and communication. Furthermore, interaction processes between the stroke individual and the informal caregiver and the mentors occurred, and generated processes of change and learning in the stroke individual and the informal caregiver. The mechanisms and processes described were perceived as feasible and acceptable to the informants - with the exception of the technological supporting tool.Conclusion: The social psychological mechanisms and processes involved in the intervention indicated a positive association to self-management behaviour from the informants' perspectives. The informants evaluated them to be relevant and meaningful in the novel self-management intervention.Trial Registration: ClinicalTrials.gov NCT03183960. Reg. June 15, 2017. [ABSTRACT FROM AUTHOR]

Background: Stroke results in varying physical, cognitive, emotional and/or social disabilities in the short and long term alike. Motor impairments are important, persistent consequences of stroke and include, among others, decreased respiratory muscle function, decreased ability to expand the thorax and postural dysfunction. These deficits affect the patient's ability to perform daily activities, produce fatigue and reduce endurance and quality of life. Inspiratory muscle training (IMT) aims to improve the strength and endurance of the diaphragm and the external intercostal muscles. The objectives of this study are to investigate the effect of 3 weeks of IMT on (i) maximal inspiratory pressure (MIP) in adults having suffered a stroke, as well as (ii) functional activities and expiratory measurements.Methods/design: This is a randomised controlled trial (RCT) comparing IMT with conventional neurorehabilitation (usual practice). The trial will include 80 patients with reduced MIP hospitalised at a specialised neurorehabilitation hospital in Denmark. The intervention group will receive IMT sessions, exercising at 30% of MIP. Patients in the intervention group will perform two daily sessions (one session of IMT with Threshold IMT consisting of two times 15 inspirations at normal breathing rhythm (5-10 min)), 7 days a week for 3 weeks. Training can be with or without physiotherapist supervision.Study Outcomes: MIP assessed by the Power Breath, Functional Independence Measurement, The 6-min walk test, the Fatigue Severity Scale and average voice volume. Expiratory function will be assessed using spirometry. All assessments will be conducted at baseline and 3 weeks (at termination of the intervention) and 3 months after the intervention has concluded.Discussion: IMT is a promising and partly self-managed tool for rehabilitation to improve respiratory function. The introduction of IMT in combination with traditional physical therapy may enhance faster recovery after stroke and may at the same time demand little personnel resources to increase training intensity. This trial will provide further evidence of IMT to clinicians, patients and health managers. Hereby, this study accepts the call for further research.Trial Registration: ClinicalTrials.gov NCT04686019 . Registered on 28 December 2020. [ABSTRACT FROM AUTHOR]

Background: Virtual reality (VR) training is thought to improve upper limb (UL) motor function after stroke when utilizing intensive training with many repetitions. The purpose of this study was to compare intensity and content of a VR training intervention to a conventional task-oriented intervention (CT). Methods: A random sample of 50 video recordings was analyzed of patients with a broad range of UL motor impairments (mean age 61y, 22 women). Patients took part in the VIRTUES trial and were randomized to either VR or CT and stratified according to severity of paresis. A standardized scoring form was used to analyze intensity, i.e. active use of the affected UL expressed in % of total time, total active time and total duration of a training session in minutes, content of training and feedback. Two raters collected data independently. Linear regression models as well as descriptive and graphical methods were used. Results: Patients in the VR group spent significantly more time actively practicing with an activity rate of 77.6 (8.9) % than patients in the CT 67.3 (13.9) %, (p = .003). This difference was attributed to the subgroup of patients with initially severe paresis (n = 22). While in VR severely impaired patients spent 80.7 % (4.4 %) of the session time actively; they reached 60.6 (12.1) % in CT. VR and CT also differed in terms of tasks and feedback provided. Conclusion: Our results indicate that patients with severely impaired UL motor function spent more time actively in VR training, which may influence recovery. The upcoming results of the VIRTUES trial will show whether this is correlated with an increased effect of VR compared to CT. [ABSTRACT FROM AUTHOR]

Background Novel virtual reality rehabilitation systems provide the potential to increase intensity and offer challenging and motivating tasks. The efficacy of virtual reality systems to improve arm motor function early after stroke has not been demonstrated yet in sufficiently powered studies. The objective of the study is to investigate whether VR training as an adjunct to conventional therapy is more effective in improving arm motor function in the subacute phase after stroke than dose-matched conventional training, to assess patient and therapist satisfaction when working with novel virtual reality training and to calculate costeffectiveness in terms of resources required to regain some degree of dexterity. Methods/Design Randomized controlled observer-blind trial. One hundred and twenty patients up to 12 weeks after stroke will be randomized to either a group receiving VR training or dose-matched and therapist attention-matched conventional arm training in addition to standard rehabilitation. During a period of four weeks the patients will be offered additional 4-5 training sessions a week of 45-60 minutes duration by a physiotherapist or an occupational therapist. Study outcomes: Arm motor function, dexterity and independence in daily life activities will be evaluated at baseline, post treatment and three months follow-up assessments with the Action Research Arm Test, Box and Blocks Test and the Functional Independence Measure, respectively. Patient and therapist satisfaction with the implementation of a VR rehabilitation system will also be assessed with questionnaires and interviews. Discussion Virtual reality systems are promising tools for rehabilitation of arm motor function after stroke. Their introduction in combination with traditional physical and occupational therapy may enhance recovery after stroke, and at the same time demand little personnel resources to increase training intensity. The VIRTUES trial will provide further evidence of VR-based treatment strategies to clinicians, patients and health economists. Trial registration ClinicalTrials.gov NCT02079103 [ABSTRACT FROM AUTHOR]

Background: Novel virtual reality rehabilitation systems provide the potential to increase intensity and offer challenging and motivating tasks. The efficacy of virtual reality systems to improve arm motor function early after stroke has not been demonstrated yet in sufficiently powered studies. The objective of the study is to investigate whether VR training as an adjunct to conventional therapy is more effective in improving arm motor function in the subacute phase after stroke than dose-matched conventional training, to assess patient and therapist satisfaction when working with novel virtual reality training and to calculate cost-effectiveness in terms of resources required to regain some degree of dexterity.Methods/design: Randomized controlled observer-blind trial.Discussion: Virtual reality systems are promising tools for rehabilitation of arm motor function after stroke. Their introduction in combination with traditional physical and occupational therapy may enhance recovery after stroke, and at the same time demand little personnel resources to increase training intensity. The VIRTUES trial will provide further evidence of VR-based treatment strategies to clinicians, patients and health economists.Trial Registration: ClinicalTrials.gov NCT02079103. [ABSTRACT FROM AUTHOR]