Efficacy of End-Effector Robot-Assisted Gait Training Combined With Robotic Balance Training in Subacute Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Over the last years, the introduction of robotic technologies in gait rehabilitation of
      stroke patients has aroused great interest. Some studies have been conducted to evaluate the
      effects of robot-assisted training compared to conventional gait rehabilitation in patients
      with subacute stroke but no studies seem to investigate the effects of a combined robotic
      treatment (gait plus balance).

      The aim of this study is to evaluate the efficacy of a combined gait and balance robotic
      rehabilitation compared robotic gait training alone.
    

Detailed description: 
      Stroke is not only the third cause of death after cardiovascular disease and cancer, but also
      the first cause of disability in the world with a significant impact on individuals, their
      families and finances. Post-stroke disability involves mobility and balance, muscle strength,
      control of movement, and gait pattern functions. Although the majority of stroke patients
      learns to walk independently by 6 months after stroke, gait and balance problems persist
      through the chronic stage and may have a significant impact on patients' quality of life.
      Accordingly, the restoration and improvement of walking functions is a primary concern to
      obtain independence in daily life. For this reason, gait recovery is a realist goal in the
      rehabilitation of almost all patients with stroke. The recovery of a more fluid, safe and
      correct execution of motor tasks such as gait and stair climbing are a prerequisite for the
      patients to become autonomous in the activities of daily living.

      Over the last years, the introduction of robotic technologies in gait rehabilitation of
      stroke patients has aroused great interest. Some studies have been conducted to evaluate the
      effects of robot-assisted training compared to conventional gait rehabilitation in patients
      with subacute stroke. The main results were obtained using robotic exoskeletons or a
      treadmill training with partial body weight support and only a few studies used an
      end-effector device. Preliminary studies have shown that end-effector Robot-Assisted Gait
      Training (RAGT) has produced promising effects on motor and functional outcomes in chronic
      and subacute strokes patients comparing with conventional treatment. Moreover, safe gait
      needs a continuous dynamic balance than it is possible that in gait robotic rehabilitation
      could be included a rehabilitation treatment of static and dynamic balance with a robotic
      proprioceptive platform. The hypothesis of the study is that a combined robotic treatment
      (gait plus balance) could produce more effects than just one robotic gait training.

      Therefore, the aim of this study is to evaluate the efficacy of gait and balance robotic
      rehabilitation in subacute stroke patients in terms of clinical outcomes, balance measures
      and gait kinematics, comparing them with robotic gait training alone.

      The patients following first ever stroke in sub-acute phase will be recruited and assessed
      both clinically and instrumentally (Gait Analysis and Balance evaluation) at baseline (T0),
      after 12 sessions (T1) and at the end of the training program (24 sessions: T2). The patients
      will be randomized into 2 groups and will conduct two different types of rehabilitation
      training: one group will perform, gait training using an end-effector robotic device for RAGT
      (Gait Group, GG); and the other group will receive a combined robotic treatment program with
      the same end-effector robotic system and a robotic proprioceptive platform (Balance Group,
      GHG). The rehabilitation program of both groups will be combined with conventional
      physiotherapy.
    

Intervention name(s): GEO; GEO and HUNOVA
Intervention type(s): Device; Device
Intervention description(s): Robot-Assisted Gait Training (RAGT) The Robotic Group (RG) performs a Robot-Assisted Gait Training (RAGT) using an end-effector robotic device (G-EO system-Reha Technology-Olten, Switzerland).; Robot-Assisted Gait Training (RAGT) and Balance Training. The Balance Group (GHG) performs a Robot-Assisted Gait Training (RAGT) using an end-effector robotic device (G-EO system-Reha Technology-Olten, Switzerland) and a Balance training using a robotic proprioceptive platform (Hunova - Movendo Technology, Italy).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Robotics; Gait Training; Rehabilitation; Balance; Functional Recovery; Robot-Assisted Gait Training