Protocol for promoting recovery optimization of walking activity in stroke (PROWALKS): a randomized controlled trial.
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SUBMITTER: Wright H
PROVIDER: S-EPMC5898044 | biostudies-literature | 2018 Apr
REPOSITORIES: biostudies-literature
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Protocol for promoting recovery optimization of walking activity in stroke (PROWALKS): a randomized controlled trial.
Wright Henry H Wright Tamara T Pohlig Ryan T RT Kasner Scott E SE Raser-Schramm Jonathan J Reisman Darcy D
BMC neurology 20180412 1
<h4>Background</h4>Stroke survivors are more physically inactive than even the most sedentary older adults, and low activity is associated with increased risk of recurrent stroke, medical complications, and mortality. We hypothesize that the combination of a fast walking intervention that improves walking capacity, with a step activity monitoring program that facilitates translation of gains from the clinic to the "real-world", would generate greater improvements in real world walking activity t ...[more]
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Project description:BackgroundPhysical inactivity in people with chronic stroke profoundly affects daily function and increases recurrent stroke risk and mortality, making physical activity improvements an important target of intervention. We compared the effects of a highintensity walking intervention (FAST), a step activity monitoring behavioral intervention (SAM), or a combined intervention (FAST+SAM) on physical activity (i.e., steps per day). We hypothesized the combined intervention would yield the greatest increase in steps per day.MethodsThis assessor-blinded multi-site randomized controlled trial was conducted at four university/hospital-based laboratories. Participants were 21-85 years old, walking without physical assistance following a single, unilateral non-cerebellar stroke of ≥6 months duration, and randomly assigned to FAST, SAM, or FAST+SAM for 12 weeks (2-3 sessions/week). FAST training consisted of walking-related activities for 40 minutes/session at 70-80% heart rate reserve, while SAM received daily feedback and goal-setting of walking activity (steps per day). Assessors and study statistician were masked to group assignment.The a priori-determined primary outcome and primary endpoint was change in steps per day from pre- to post-intervention. Adverse events (AEs) were tracked after randomization. All randomized participants were included in the intent-to-treat analysis.This study is registered at ClinicalTrials.gov, NCT02835313.FindingsParticipants were enrolled from July 18, 2016-November 16, 2021. Of 250 randomized participants (mean[SE] age 63[0.80], 116F/134M), 89 were assigned to FAST, 81 to SAM, and 80 to FAST+SAM. Steps per day significantly increased in both the SAM (mean[SE] 1542[267], 95%CI:1014-2069, p<0.001) and FAST+SAM groups (1307[280], 752-1861, p<0.001), but not in the FAST group (406[238], 63-876, p=0.09). There were no deaths or serious study-related AEs and all other minor AEs were similar between groups.InterpretationOnly individuals with chronic stroke who completed a step activity monitoring behavioral intervention with skilled coaching and goal progression demonstrated improvements in physical activity (steps per day).
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Project description:Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia.The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity.The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex interventions. It combines classical effectiveness evaluation with a thorough process evaluation. The results from this study may inform the development of further trials aimed at promoting psychosocial well-being following stroke as well as inform the psychosocial follow up of stroke patients living at home.NCT02338869 ; registered 10/04/2014 (On-going trial).
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Project description:Background: Stroke is a leading cause of disability. Nonetheless, the care pathway for stroke rehabilitation takes partially into account the needs of chronic patients. This is due in part to the lack of evidence about the mechanisms of recovery after stroke, together with the poor knowledge of related and influencing factors. Here we report on the study protocol "Rehabilitation and Biomarkers of Stroke Recovery," which consists of 7 work-packages and mainly aim to investigate the effects of long-term neurorehabilitation on stroke patients and to define a related profile of (clinical-biological, imaging, neurophysiological, and genetic-molecular) biomarkers of long-term recovery after stroke. The work-package 1 will represent the main part of this protocol and aims to compare the long-term effects of intensive self-rehabilitation vs. usual (rehabilitation) care for stroke. Methods: We planned to include a total of 134 adult subacute stroke patients (no more than 3 months since onset) suffering from multidomain disability as a consequence of first-ever unilateral ischemic stroke. Eligible participants will be randomly assigned to one of the following groups: intensive self-rehabilitation (based on the principles of "Guided Self-Rehabilitation Contract") vs. usual care (routine practice). Treatment will last 1 year, and patients will be evaluated every 3 months according to their clinical presentation. The following outcomes will be considered in the main work-package: Fugl-Meyer assessment, Cognitive Oxford Screen Barthel Index, structural and functional neuroimaging, cortical excitability, and motor and somatosensory evoked potentials. Discussion: This trial will deal with the effects of an intensive self-management rehabilitation protocol and a related set of biomarkers. It will also investigate the role of training intensity on long-term recovery after stroke. In addition, it will define a set of biomarkers related to post-stroke recovery and neurorehabilitation outcome in order to detect patients with greater potential and define long-term individualized rehabilitation programs. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04323501.
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Project description:BACKGROUND:The ability to adapt walking to environmental properties and hazards, a prerequisite for safe ambulation, is often impaired in persons after stroke. RESEARCH QUESTION:The aim of this study was to compare the efficacy of two walking-adaptability interventions: a novel treadmill-based C-Mill therapy (using gait-dependent augmented reality) and the standard overground FALLS program (using physical context). We expected sustained improvements for both treatment groups combined but hypothesized better outcomes for C-Mill therapy than the FALLS program due to its expected greater amount of walking practice. METHODS:In this pre-registered single-centre parallel group randomized controlled trial, forty persons after stroke (≥ 3 months ago) with walking and/or balance deficits were randomly allocated to either 5 weeks of C-Mill therapy or the FALLS program. The primary outcome measure was the standard walking speed as determined with the 10-meter walking test (10MWT). Additionally, context-specific walking speed was assessed in environments enriched with either stationary physical context (10MWT context) or suddenly appearing visual images (Interactive Walkway obstacles). The walking-adaptability scores of those enriched walking tests served as secondary outcome measures. Furthermore, a cognitive task was added to all three assessments to evaluate dual-task performance in this context. Finally, the participants' experience and amount of walking practice were scored. The outcome measures were assessed at four test moments: pre-intervention (T0), post-intervention (T1), 5-week post-intervention retention (T2), and 1-year post-intervention follow-up (T3). RESULTS:No significant group differences were found between the interventions for the primary outcome measure standard walking speed, but we found a greater improvement in context-specific walking speed with stationary physical context of the C-Mill therapy compared to the FALLS program at the post-intervention test, which was no longer significant at retention. Both interventions were well received, but C-Mill therapy scored better on perceived increased fitness than the FALLS program. C-Mill therapy resulted in twice as many steps per session of equal duration than the FALLS program. The "change-over-time" analyses for participants of both interventions combined showed no significant improvements in the standard walking speed; however, significant improvements were found for context-specific walking speed, walking adaptability, and cognitive dual-task performance. SIGNIFICANCE:This study showed no between-group differences between the novel treadmill-based C-Mill therapy and the standard overground FALLS program with respect to the primary outcome measure standard walking speed. However, the greater amount of walking practice observed for the C-Mill group, an essential aspect of effective intervention programs after stroke, may underlie the reported increased perceived fitness and observed increased context-specific walking speed for the C-Mill group directly after the intervention. Although the "change-over-time" results for all participants combined showed no improvement in the standard walking speed, context-specific walking speed and walking adaptability showed sustained improvements after the interventions, underscoring the importance of including walking-adaptability training and assessment in rehabilitation post stroke. TRIAL REGISTRATION:The Netherlands Trial Register NTR4030 . Registered 11 June 2013.
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Project description:Regaining independent ambulation is the top priority for individuals recovering from stroke. Thus, physical rehabilitation post-stroke should focus on improving walking function and endurance. However, the amount of walking completed by individuals with stroke attending rehabilitation is far below that required for independent community ambulation. There has been increased interest in accelerometer-based monitoring of walking post-stroke. Walking monitoring could be integrated within the goal-setting process for those with ambulation goals in rehabilitation. The feedback from these devices can be downloaded to a computer to produce reports. The purpose of this study is to determine the effect of accelerometer-based feedback of daily walking activity during rehabilitation on the frequency and duration of walking post-stroke.Participants will be randomly assigned to one of two groups: feedback or no feedback. Participants will wear accelerometers daily during in- and out-patient rehabilitation and, for participants in the feedback group, the participants' treating physiotherapist will receive regular reports of walking activity. The primary outcome measures are the amount of daily walking completed, as measured using the accelerometers, and spatio-temporal characteristics of walking (e.g. walking speed). We will also examine goal attainment, satisfaction with progress towards goals, stroke self-efficacy, and community-integration.Increased walking activity during rehabilitation is expected to improve walking function and community re-integration following discharge. In addition, a focus on altering walking behaviour within the rehabilitation setting may lead to altered behaviour and increased activity patterns after discharge.ClinicalTrials.gov NCT01521234.
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Project description:BACKGROUND:Stroke causes functional decline, psychological disorders and cognitive impairments that affect activities of daily living and quality of life. Although physical activity (PA) is beneficial in stroke recovery, PA recommendations are rarely met after hospital discharge. There is presently no standard strategy for monitoring and inciting PA at home during the subacute phase of stroke recovery. The main aim of this study is to evaluate the effects of a home-based physical activity incentive and education program (Ticaa'dom) on functional capacity in subacute stroke patients. METHODS:This study is a comparative prospective, observer-blinded, monocentric, parallel, randomized controlled clinical trial. This study will include 84 patients: 42 patients in the home-based physical activity incentive group (HB-PAI) and 42 in the control group (CG). The intervention group will follow the HB-PAI program over 6 months: their PA will be monitored with an accelerometer during the day at home while they record their subjective perception of PA on a chart; they will observe a weekly telephone call and a home visit every three weeks. The CG will receive traditional medical care over 12 months. The main study outcome will be the distance on a 6-minute walk test. Secondary outcomes will include measurements of lower limb strength, independence level, body composition, cardiac analysis, fatigue and depression state. DISCUSSION:The results of this trial will demonstrate the value of implementing the Ticaa'dom program during the subacute phase of stroke recovery. TRIAL REGISTRATION:ClinicalTrials.gov, NCT01822938 . Registered on 25 March 2013.
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Project description:BackgroundStroke results in neurologic impairments and aerobic deconditioning that contribute to limited walking capacity which is a major barrier post-stroke. Current exercise recommendations and stroke rehabilitation guidelines recommend moderate-intensity aerobic training post-stroke. Locomotor high-intensity interval training is a promising new strategy that has shown significantly greater improvements in aerobic fitness and motor performance than moderate-intensity aerobic training in other populations. However, the relative benefits and risks of high-intensity interval training and moderate-intensity aerobic training remain poorly understood following stroke. In this study, we hypothesize that locomotor high-intensity interval training will result in greater improvements in walking capacity than moderate-intensity aerobic training.MethodsUsing a single-blind, 3-site randomized controlled trial, 50 chronic (> 6 months) stroke survivors are randomly assigned to complete 36 locomotor training sessions of either high-intensity interval training or moderate-intensity aerobic training. Main eligibility criteria are age 40-80 years, single stroke for which the participant received treatment (experienced 6 months to 5 years prior to consent), walking speed ≤ 1.0 m/s, able to walk at least 3 min on the treadmill at ≥ 0.13 m/s (0.3 mph), stable cardiovascular condition (American Heart Association class B), and the ability to walk 10 m overground without continuous physical assistance. The primary outcome (walking capacity) and secondary outcomes (self-selected and fast gait speed, aerobic fitness, and fatigue) are assessed prior to initiating training and after 4 weeks, 8 weeks, and 12 weeks of training.DiscussionThis study will provide fundamental new knowledge to inform the selection of intensity and duration dosing parameters for gait recovery and optimization of aerobic training interventions in chronic stroke. Data needed to justify and design a subsequent definitive trial will also be obtained. Thus, the results of this study will inform future stroke rehabilitation guidelines on how to optimally improve walking capacity following stroke.Trial registrationClinicalTrials.gov NCT03760016 . Registered on November 30, 2018.
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Project description:BackgroundTimely provision of an ankle-foot orthosis (AFO) orthotist customized for individuals early after stroke can be problematic.ObjectiveTo evaluate the efficacy of a therapist-made AFO (SWIFT Cast) for walking recovery.MethodsThis was a randomized controlled, observer-blind trial. Participants (n = 105) were recruited 3 to 42 days poststroke. All received conventional physical therapy (CPT) that included use of "off-the-shelf" and orthotist-made AFOs. People allocated to the experimental group also received a SWIFT Cast for up to 6 weeks. Measures were undertaken before randomization, 6 weeks thereafter (outcome), and at 6 months after stroke (follow-up). The primary measure was walking speed. Clinical efficacy evaluation used analysis of covariance.ResultsUse of a SWIFT Cast during CPT sessions was significantly higher (P < .001) for the SWIFT Cast (55%) than the CPT group (3%). The CPT group used an AFO in 26% of CPT sessions, compared with 11% for the SWIFT Cast group (P = .005). At outcome, walking speed was 0.42 (standard deviation [SD] = 0.37) m/s for the CPT group and 0.32 (SD = 0.34) m/s for the SWIFT Cast group. Follow-up walking speed was 0.53 (SD = 0.38) m/s for the CPT group and 0.43 (0.34) m/s for the SWIFT Cast group. Differences, after accounting for minimization factors, were insignificant at outcome (P = .345) and follow-up (P = .360).Conclusion and implicationsSWIFT Cast did not enhance the benefit of CPT, but the control group had greater use of another AFO. However, SWIFT Cast remains a clinical option because it is low cost and custom-made by therapists who can readily adapt it during the rehabilitation period.
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Project description:BackgroundAdult participation in sport is associated with important positive psychosocial outcomes. Despite the multitude of benefits that have been linked to sport participation, adult participation rates in Canada remain low. Parents with young children represent a demographic that may benefit considerably from sport participation, given the prevalence of inactivity coupled with increased levels of psychosocial distress among this group. This study aims to evaluate the efficacy of two types of sport participation (individual sport and team sport) on key psychosocial outcomes compared with a "personal time" control condition among parents with young children.Methods/designThe three-arm, parallel design, single-blind, randomized controlled trial will compare a team sport condition, an individual sport condition, and a "personal time" control condition over 3 months. Parents are eligible if they have a child under 13 years of age, are not participating in a sport at baseline, and are not meeting Canadian Physical Activity Guidelines. Psychosocial variables (quality of life, relationship satisfaction, social functioning, parental stress, and enjoyment) will be assessed at baseline, 6 weeks, and 3 months. A total of 161 parents have been recruited thus far from the Greater Victoria region in British Columbia, Canada. The study is ongoing with a target goal of 240 participants and an anticipated completion date of December 2021.DiscussionThis protocol describes the implementation of a randomized controlled trial that evaluates the effectiveness of sport participation for increasing positive psychosocial outcomes. This information could prove useful for future adult sport participation and potentially inform public health initiatives involving parents and families.Trial registrationClinicalTrials.gov, NCT02898285. Registered 13 September 2016.
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Project description:Over a third of community-residing elderly have clinical gait abnormalities, and gait impairment is associated with morbidity, mortality and dementia. Motor imagery - envisioning motor actions without actual execution - has been used to improve gait in Parkinson's disease and poststroke, but the efficacy of motor imagery in healthy elderly is unknown. This single-blind pilot randomized-controlled trial aims to establish feasibility and explore the efficacy of a 3-month, telephone-based motor imagery intervention - that involves imagined walking, imagined talking and imagined walking while talking for improving gait in 48 healthy elderly. The primary outcomes will be gait speed during actual walking and walking while talking. Secondary outcomes will include cognitive performance during actual talking and walking while talking, and functional neuroplasticity during imagined walking and walking while talking. This clinical trial has been registered on clinicaltrials.gov (identifier NCT02762604).
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