Abstract
BackgroundStroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. The incidence of stroke rapidly increases with age, doubling for each decade after age 55 years. Gait impairment is one of the most important problems after stroke, and improving walking function is often a key component of any rehabilitation program. To achieve this goal, a robotic gait trainer seems to be promising. In fact, some studies underline the efficacy of robotic gait training based on end-effector technology, for different diseases, in particular in stroke patients. In this randomized controlled trial, we verify the efficacy of the robotic treatment in terms of improving the gait and reducing the risk of falling and its long-term effects.MethodsIn this single-blind randomized controlled trial, we will include 152 elderly subacute stroke patients divided in two groups to receive a traditional rehabilitation program or a robotic rehabilitation using G-EO system, an end-effector device for the gait rehabilitation, in addition to the traditional therapy. Twenty treatment sessions will be conducted, divided into 3 training sessions per week, for 7 weeks. The control group will perform traditional therapy sessions lasting 50 min. The technological intervention group, using the G-EO system, will carry out 30 min of traditional therapy and 20 min of treatment with a robotic system. The primary outcome of the study is the evaluation of the falling risk. Secondary outcomes are the assessment of the gait improvements and the fear of falling. Further evaluations, such as length and asymmetry of the step, walking and functional status, and acceptance of the technology, will be carried.DiscussionThe final goal of the present study is to propose a new approach and an innovative therapeutic plan in the post-stroke rehabilitation, focused on the use of a robotic device, in order to obtain the beneficial effects of this treatment.Trial registrationClinicalTrials.gov NCT04087083. Registered on September 12, 2019
Highlights
Stroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences
The study aims to evaluate the effect of the rehabilitation treatment on the balance and gait performance, on the gait speed, on the fear of falling, and on the quality of life, acceptance of technology, and improvement of functional status as results of the use of the G-EO system
The target population of the study consists of stroke patients within 3 months from the event, who need physical assistance from another person to walk in the form of continuous or intermittent manual contact, or who cannot walk independently
Summary
Stroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. Gait impairment is one of the most important problems after stroke, and improving walking function is often a key component of any rehabilitation program To achieve this goal, a robotic gait trainer seems to be promising. Gait impairment is one of the most important problems after stroke and it is associated with difficulties in performing daily activities and in maintaining indoor and outdoor mobility For this reason, improving walking function is often a key component of any rehabilitation program. To achieve this goal, a specific task-repetitive training seems the most promising one since, by increasing therapy dosage, intensity, and number of repetitions, the plasticity and the functional recovery are promoted [7,8,9]. On the basis of the support provided, the electromechanical devices can be divided into inactive, passive, active-assisted, resistive, and interactive devices [13]
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