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Robot Walking Rehabilitation in Stroke Patients

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ClinicalTrials.gov Identifier: NCT01678547
Recruitment Status : Unknown
Verified February 2014 by Patrizio Sale , MD, IRCCS San Raffaele.
Recruitment status was:  Recruiting
First Posted : September 5, 2012
Last Update Posted : February 14, 2014
Sponsor:
Information provided by (Responsible Party):
Patrizio Sale , MD, IRCCS San Raffaele

Tracking Information
First Submitted Date  ICMJE August 31, 2012
First Posted Date  ICMJE September 5, 2012
Last Update Posted Date February 14, 2014
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2012)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2012)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Robot Walking Rehabilitation in Stroke Patients
Official Title  ICMJE 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 Description

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 EMG quantitative data during selected movements (gait, posture, ) compared with age matched reference data;
  5. to investigate the stability of the effects of robot-assisted treatment at 4/6 months follow-up in terms of Quality of Life (QoL).

A first goal of this project is to investigate the differences in improvement of the quality and safety of the gait (motor performance and functional recovery) through kinematic/kinetic and EMG parameters (Change in Step Length, Change in Gait Velocity and Change in Stride Time Variability, 3D joints kinematics, ground reaction forces, joint kinetics, muscle activation,) and traditional clinical scales in sub-acute and chronic stroke patients.

The second goals is aimed at identifying possible advantages in the QoL of patients undergoing such a kind of in-patients and out-patients rehabilitation treatment and at investigating novel methods enabling lower limb functional recovery, leading to wide potential for regaining personal independence.

The third goal is to analyse direct cost savings associated with the use of such technologies, measured as direct, indirect and intangible costs, through specific HTA procedures.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Gait Disorders, Neurologic
Intervention  ICMJE
  • Device: Robot-assisted walking
    The practice will included an add-on robot-assisted walking therapy at variable speeds for 40 min with a partial body weight support (BWS). All participants will start with 30-40% BWS and an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h and the BWS % will be decreased.
    Other Name: G-EO System (Reha Technology AG Switzerland)
  • Device: Treadmill Training
    The practice will included an add-on treadmill walking therapy at variable speeds for 40 min with a partial body weight support (BWS). All participants will start with 30-40% BWS and an initial comfortable treadmill speed and the speed will be increased to a range of 1,0 to 2.5 km/h and the BWS % will be decreased.
    Other Name: Gait Trainer 3 (Biodex Medical Systems New York)
  • Other: Ground treatment
    The practice will included ground walking therapy s for 40 min with therapist support.
    Other Name: Physiotherapy treatment.
Study Arms  ICMJE
  • Experimental: Robot G-EO
    Each subject will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) consisting of a treatment cycle using the GE-O system device, according to individually tailored exercise scheduling.
    Intervention: Device: Robot-assisted walking
  • Active Comparator: Treadmill Training
    Each subject will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) consisting of a treatment cycle using the treadmill system device, according to individually tailored exercise scheduling.
    Intervention: Device: Treadmill Training
  • Active Comparator: Ground treatment
    Ground Control Group (cCG): Each subject will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) of traditional lower limb physiotherapy treatment.
    Intervention: Other: Ground treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 31, 2012)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • between the ages of 18-95 years;
  • able to walk 25 feet unassisted or with assistance
  • truck control
  • first acute event of cerebrovascular stroke
  • unilateral paresis,
  • ability to understand and follow simple instructions
  • ability to walk without assistance prior to stroke
  • endurance sufficient to stand at least 20 minutes unassisted per patient report.

Exclusion Criteria:

  • unable to understand instructions required by the study (Informed Consent Test of Comprehension).
  • medical or neurological comorbidities that might contribute to significant gait dysfunction.
  • uncontrolled hypertension > 190/110 mmHg.
  • significant symptoms of orthostasis when standing up.
  • circulatory problems, history of vascular claudication or significant (+3) pitting edema.
  • lower extremity injuries or joint problems (hip or leg) that limit range of motion or function, or cause pain with movement
  • bilateral impairment,
  • severe sensory deficits in the paretic upper limb,
  • cognitive impairment or behavioral dysfunction that would influence the ability to comprehend or participate in the study.
  • Women who are pregnant and/or lactating.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01678547
Other Study ID Numbers  ICMJE RoboSTROKE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patrizio Sale , MD, IRCCS San Raffaele
Study Sponsor  ICMJE IRCCS San Raffaele
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrizio Sale, MD IRCCS San Raffaele Pisana Rome Italy
PRS Account IRCCS San Raffaele
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP