Elvira Maranesi1,2, Roberta Bevilacqua3, Mirko Di Rosa4, Giuseppe Pelliccioni5, Valentina Di Donna6, Riccardo Luzi7, Micaela Morettini8, Agnese Sbrollini8, Elisa Casoni9, Nadia Rinaldi6, Renato Baldoni9, Fabrizia Lattanzio3, Laura Burattini8, Giovanni R Riccardi9. 1. Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy. e.maranesi@inrca.it. 2. Scientific Direction, IRCCS INRCA, Ancona, Italy. e.maranesi@inrca.it. 3. Scientific Direction, IRCCS INRCA, Ancona, Italy. 4. Unit of Geriatric Pharmacoepidemiology, IRCCS INRCA, Ancona, Italy. 5. Neurology Unit, IRCCS INRCA, Ancona, Italy. 6. Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy. 7. Medical Direction, IRCCS INRCA, Ancona, Italy. 8. Cardiovascular Bioengineering Lab, Department of Information Engineering, Università Politecnica delle Marche, Ancona, Italy. 9. Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.
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.
RCT Entities:
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 strokepatients. 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 strokepatients 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.
Authors: Jan F Veneman; Rik Kruidhof; Edsko E G Hekman; Ralf Ekkelenkamp; Edwin H F Van Asseldonk; Herman van der Kooij Journal: IEEE Trans Neural Syst Rehabil Eng Date: 2007-09 Impact factor: 3.802
Authors: Thomas Truelsen; Markku Mähönen; Hanna Tolonen; Kjell Asplund; Ruth Bonita; Diego Vanuzzo Journal: Stroke Date: 2003-05-08 Impact factor: 7.914
Authors: Giovanni Taveggia; Alberto Borboni; Chiara Mulé; Jorge H Villafañe; Stefano Negrini Journal: Int J Rehabil Res Date: 2016-03 Impact factor: 1.479