Protocol for promoting recovery optimization of walking activity in stroke (PROWALKS): a randomized controlled trial.
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ABSTRACT:
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: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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Project description:BackgroundGait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy, presenting a major obstacle towards regaining activities-of-daily-living performance and achieving social reintegration.ObjectiveThis study aims to clarify the effectiveness of a walking program involving the wearable Hybrid Assistive Limb (HAL-TS01) robotic exoskeleton for improving walking ability in stroke patients with hemiparesis and stagnant recovery despite ongoing rehabilitation.MethodsThis is a multicenter, randomized, parallel-group, controlled study (HAL group, n=27; control group, n=27). The study period includes preintervention observation (until stagnant recovery), intervention (HAL-based walking therapy or conventional rehabilitation; 5 weeks), and postintervention observation (2 weeks). Following provision of informed consent and primary registration, the patients undergo conventional rehabilitation for preintervention observation, during which the recovery of walking ability is monitored to identify patients with stagnant recovery (based on weekly assessments using the 10-meter maximum walking speed [MWS] test). Patients with an MWS of 30-60 m/minute and insufficient weekly improvement in MWS undergo secondary registration and are randomly assigned to undergo HAL-based walking therapy (HAL group) or conventional rehabilitation (control group). The primary outcome is the change in MWS from baseline to the end of the 5-week intervention.ResultsThis study began in November 2016 and is being conducted at 15 participating facilities in Japan.ConclusionsAssessments of walking ability vary greatly and it is difficult to define the threshold for significant differences. To reduce such variability, our study involves conducting conventional rehabilitation to the point of saturation before starting the intervention. Stagnation in the recovery of walking ability despite conventional rehabilitation highlights the limits of current medical care. The present study may bring evidence that HAL-based therapy can overcome such limitations and induce added recovery of walking ability, which would promote the use of HAL technology in the clinical setting.Trial registrationUMIN Clinical Trials Registry UMIN000024805; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028545.
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