Clinical Trial: Robot Walking Rehabilitation in Stroke Patients

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effect of Robot Assisted Treatment on Gait Performace in Stroke Patients

Brief Summary: Stroke are the main causes of motor disability among adults and are expected to impose an increasing social and economic burden for our Country. The impact of stroke on patients is enormous, with negative ramifications on the persons participation in social, vocational, and recreational activities. It is the primary cause of long-term disability in these countries. At the present stage, it is well known that control of balance during upright standing depends upon the central integration of afferent information from vestibular, somatosensory (proprioceptive, tactile), and visual systems, which constitute a multilink neural network for the control of neck, hip, and ankle joints. More recently, it has been studied at the level of cerebral cortex; vestibular inputs would reach face/neck representation of primary somatosensory cortex and would be then integrated with visual and somatosensory inputs in intraparietal, posterior end of the insula and medial superior temporal cortices. Remarkably, balance impairment and the associated risk of falling represent one of the most prominent and potentially disabling features in stroke subjects. The specific aims of this project are: to verify whether the robotics lower limb treatment with body weight support is more effective than the treadmill treatment in the reduction of motor impairment in Stroke patients, and to improve the quality of the gait and the endurance and to analyze possible improvements in terms of physiological biomechanical gait through analysis of spatio-temporal parameters.

Detailed Summary:

Objective: to assess the lower limb recovery after the gait rehabilitation training exercises in acute and chronic stroke patients.

The proposed project, through a Randomized controlled observer-blind trial aimed at evaluating the effectiveness of end-effector robot assisted therapy vs the treadmill and ground treatment in sub-acute and chronic stroke subjects. 90 inpatients and out-patients with a stroke will be recruited. We will randomize the patients on 3 groups [15 sub-acute (ischemic and hemorrhagic) stroke patients (after 30±7 days from injury) and 15 chronic (ischemic and hemorrhagic) patients (after 3/6 months days from injury) for all groups]:

  1. sub-acute and chronic stroke patients robot treatment.
  2. sub-acute and chronic patients treadmill treatment.
  3. sub-acute and chronic patients ground treatment.

The specific aims of this project are:

  1. to verify whether the robotics end-effector GEO lower limb treatment with body weight support is more effective than the treadmill treatment or ground treatment in the reduction of motor impairment in sub-acute and Chronic stroke patients, and to improve the quality of the gait and the endurance;
  2. to analyse possible improvements in terms of physiological biomechanical gait through analysis of kinematics , kinetics and EMG evaluation;
  3. to analyse possible improvements in terms of reduction of instable posture and movements, which can represent a reduction of the risk of fall typical of these subjects;
  4. to evaluate the kinematic, kinetic and
    Sponsor: IRCCS San Raffaele

    Current Primary Outcome: 6 minuts walking test. [ Time Frame: Change from Baseline in gait speed at 6 months follow up. ]

    The 6 minuts walking test as primary outcome assessments will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Fugl Meyer (lower limb section) [ Time Frame: Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up. ]
      The Fugl Meyer (lower limb section) scale will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).
    • Borg scale [ Time Frame: Change from Baseline in Borg scale at 6 months follow up. ]
      Cost of Waking walking effort using Borg scale will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).
    • Gait Parameters with EMG [ Time Frame: baseline, weekly during intervention, 6 months follow up ]
      Gait analysis with EMG will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).
    • Functional Ambulation Classification [ Time Frame: Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up. ]
      The Functional Ambulation Classification will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).
    • Walk Handicap Scale (WHS) [ Time Frame: Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up. ]
      The Walk Handicap Scale (WHS) will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).


    Original Secondary Outcome: Same as current

    Information By: IRCCS San Raffaele

    Dates:
    Date Received: August 31, 2012
    Date Started: September 2012
    Date Completion: September 2015
    Last Updated: February 12, 2014
    Last Verified: February 2014