Innovative Models in the Rehabilitation of the Elderly With Stroke Through Technological Innovation
Innovative Models in the Rehabilitation of the Elderly With Stroke Through Technological Innovation
The final goal of the present study is to propose a new approach and an innovative
 therapeutic plan in the post-stroke rehabilitation of elderly patients, focused on the use of
 robotic device, in order to obtain the beneficial effects of this treatment.
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 improve walking function is
 often a key component of any rehabilitation program. To achieve this goal, 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.

 In this single blind randomized controlled trial the investigators will include 150 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. A 20 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 minutes. The technological intervention
 group, using G-EO system, will carry out 30 minutes of traditional therapy and 20 minutes 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, acceptance of the technology, will be carried.
Inclusion Criteria:

 -  Capacity to consent

 -  Ischemic or hemorrhagic stroke within 3 months to the recruitment, proven by
 computerized axial tomography or nuclear magnetic resonance

 -  Functional Ambulation Category (FAC) score ≤ 2

 -  Ranking scale score ≤ 3

 -  Complete communication and comprehension skills, assessed during the objective
 examination

 -  Ability to stand upright, supported or unsupported, for 1 minute

 Exclusion Criteria:

 -  Concomitant participation in other studies

 -  Severe hypertonus of the hip, knee, ankle of the paretic leg with a modified Ashworth
 scale score ≥3

 -  Severe hip, knee or ankle contracture or orthopedic problem affecting ambulation that
 would preclude passive range of motion of the paretic leg

 -  Deep vein thrombosis of the lower limbs

 -  Other cognitive, motor and sensory deficits that negatively condition robotic training

 -  Treatment of spasticity of the lower limb within 3 months to the start of the study or
 during the study

 -  Lack of written informed consent

 -  Clinical dementia rating (CDR) score ≥ 3

 -  Severe systemic diseases with life expectancy < 1 year