Protocol for promoting recovery optimization of walking activity in stroke (PROWALKS): a randomized controlled trial

Abstract

BackgroundStroke 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 than with either intervention alone.MethodsUsing a single-blind randomized controlled experimental design, 225 chronic (> 6 months) stroke survivors complete 12 weeks of fast walking training, a step activity monitoring program or a fast walking training + step activity monitoring program. Main eligibility criteria include: chronic ischemic or hemorrhagic stroke (> 6 months post), no evidence of cerebellar stroke, baseline walking speed between 0.3 m/s and 1.0 m/s, and baseline average steps / day < 8000. The primary (steps per day), secondary (self-selected and fastest walking speed, walking endurance, oxygen consumption) and exploratory (vascular events, blood lipids, glucose, blood pressure) outcomes are assessed prior to initiating treatment, after the last treatment and at a 6 and 12-month follow-up. Moderation of the changes in outcomes by baseline characteristics are evaluated to determine for whom the interventions are effective.DiscussionFollowing completion of this study, we will not only understand the efficacy of the interventions and the individuals for which they are effective, we will have the necessary information to design a study investigating the secondary prevention benefits of improved physical activity post-stroke. This study is, therefore, an important step in the development of both rehabilitative and secondary prevention guidelines for persons with stroke.Trial registrationClinicalTrials.gov Identifier: NCT02835313.First Posted: July 18, 2016.

Improved walking function in laboratory does not guarantee increased community walking in stroke survivors: Potential role of gait biomechanics

“…However, these variables individually are only able to explain 10-30% of patients' stepping activity. Few studies have evaluated specific variables that may contribute to changes in stepping activity following interventions (Danks et al, 2016a;Wright et al, 2018). A better understanding of factors that can predict changes in stepping activity following physical rehabilitation may help identify patients in whom more focused interventions are required.…”

Relationships of Linear and Non-linear Measurements of Post-stroke Walking Activity and Their Relationship to Weather

“…Participants with chronic (including single or multiple) stroke(s) to either hemisphere(s), age 21–85, with the ability to walk at a self-selected walking speed >0.3 m/s and <1.0 m/s were included. Ankle-foot orthoses, canes, and walkers were allowed, but participants must be capable of walking without additional human assistance (Wright et al, 2018 ). Exclusion criteria included evidence of cerebellar stroke, other potentially disabling neurological conditions, lower limb Botox injection within fourth months, current participation in physical therapy, inability to walk outside the home before stroke, coronary artery bypass graft or stent replacement or heart attack within 3 months, or musculoskeletal pain which limits activity (Wright et al, 2018 ).…”

“…Ankle-foot orthoses, canes, and walkers were allowed, but participants must be capable of walking without additional human assistance (Wright et al, 2018 ). Exclusion criteria included evidence of cerebellar stroke, other potentially disabling neurological conditions, lower limb Botox injection within fourth months, current participation in physical therapy, inability to walk outside the home before stroke, coronary artery bypass graft or stent replacement or heart attack within 3 months, or musculoskeletal pain which limits activity (Wright et al, 2018 ). Physical activity is defined as “bodily movement produced by skeletal muscles that results in energy expenditure” ( 2018 Physical Activity Guidelines Advisory Committee , 2018 ).…”

“…Data was collected for 172 participants after their initial study visit, with those outside the reliable walking speed range being excluded afterward; the present data was collected as pre-intervention baseline data for all participants. The goal in the clinical trial was for subjects to have 7 days of useable data (Wright et al, 2018 ), so the final number of days in the initial collection period varied depending on the participant. A custom MATLAB code was utilized to analyze the activity data (MathWorks, Natick, MA, USA).…”

“…First, we removed partially recorded days and days that recorded no physical activity from our data set. Though all trial participants were contacted daily during activity monitoring as a reminder to wear the Fitbit (Wright et al, 2018 ), not every participant wore the device every day. In total, 142 of the participants had step data collected for at least 6 entire days at reliable speeds.…”