An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial

Abstract Background 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 incidence of stroke rapidly increases with age, doubling for each decade after age 55 years. Gait impa...

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Main Authors: Elvira Maranesi, Roberta Bevilacqua, Mirko Di Rosa, Giuseppe Pelliccioni, Valentina Di Donna, Riccardo Luzi, Micaela Morettini, Agnese Sbrollini, Elisa Casoni, Nadia Rinaldi, Renato Baldoni, Fabrizia Lattanzio, Laura Burattini, Giovanni R. Riccardi
Format: Article
Language:English
Published: BMC 2021-06-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-021-05357-8
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spelling doaj-b6030d7c27d741bea33f88249886f0d22021-06-20T11:30:13ZengBMCTrials1745-62152021-06-012211810.1186/s13063-021-05357-8An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trialElvira Maranesi0Roberta Bevilacqua1Mirko Di Rosa2Giuseppe Pelliccioni3Valentina Di Donna4Riccardo Luzi5Micaela Morettini6Agnese Sbrollini7Elisa Casoni8Nadia Rinaldi9Renato Baldoni10Fabrizia Lattanzio11Laura Burattini12Giovanni R. Riccardi13Clinical Unit of Physical Rehabilitation, IRCCS INRCAScientific Direction, IRCCS INRCAUnit of Geriatric Pharmacoepidemiology, IRCCS INRCANeurology Unit, IRCCS INRCAClinical Unit of Physical Rehabilitation, IRCCS INRCAMedical Direction, IRCCS INRCACardiovascular Bioengineering Lab, Department of Information Engineering, Università Politecnica delle MarcheCardiovascular Bioengineering Lab, Department of Information Engineering, Università Politecnica delle MarcheClinical Unit of Physical Rehabilitation, IRCCS INRCAClinical Unit of Physical Rehabilitation, IRCCS INRCAClinical Unit of Physical Rehabilitation, IRCCS INRCAScientific Direction, IRCCS INRCACardiovascular Bioengineering Lab, Department of Information Engineering, Università Politecnica delle MarcheClinical Unit of Physical Rehabilitation, IRCCS INRCAAbstract Background 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 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. Methods In 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. Discussion The 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 registration ClinicalTrials.gov NCT04087083 . Registered on September 12, 2019https://doi.org/10.1186/s13063-021-05357-8Stroke patientsGait trainingEnd-effector gait rehabilitation
collection DOAJ
language English
format Article
sources DOAJ
author Elvira Maranesi
Roberta Bevilacqua
Mirko Di Rosa
Giuseppe Pelliccioni
Valentina Di Donna
Riccardo Luzi
Micaela Morettini
Agnese Sbrollini
Elisa Casoni
Nadia Rinaldi
Renato Baldoni
Fabrizia Lattanzio
Laura Burattini
Giovanni R. Riccardi
spellingShingle Elvira Maranesi
Roberta Bevilacqua
Mirko Di Rosa
Giuseppe Pelliccioni
Valentina Di Donna
Riccardo Luzi
Micaela Morettini
Agnese Sbrollini
Elisa Casoni
Nadia Rinaldi
Renato Baldoni
Fabrizia Lattanzio
Laura Burattini
Giovanni R. Riccardi
An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial
Trials
Stroke patients
Gait training
End-effector gait rehabilitation
author_facet Elvira Maranesi
Roberta Bevilacqua
Mirko Di Rosa
Giuseppe Pelliccioni
Valentina Di Donna
Riccardo Luzi
Micaela Morettini
Agnese Sbrollini
Elisa Casoni
Nadia Rinaldi
Renato Baldoni
Fabrizia Lattanzio
Laura Burattini
Giovanni R. Riccardi
author_sort Elvira Maranesi
title An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial
title_short An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial
title_full An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial
title_fullStr An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial
title_full_unstemmed An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial
title_sort innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial
publisher BMC
series Trials
issn 1745-6215
publishDate 2021-06-01
description Abstract Background 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 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. Methods In 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. Discussion The 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 registration ClinicalTrials.gov NCT04087083 . Registered on September 12, 2019
topic Stroke patients
Gait training
End-effector gait rehabilitation
url https://doi.org/10.1186/s13063-021-05357-8
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