Robot Walking Rehabilitation in Stroke Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by IRCCS San Raffaele
Sponsor:
Information provided by (Responsible Party):
Patrizio Sale , MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01678547
First received: August 31, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Stroke
Gait Disorders, Neurologic
Device: Robot-assisted walking
Device: Treadmill Training
Other: Ground treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Robot Assisted Treatment on Gait Performace in Stroke Patients

Resource links provided by NLM:


Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • 6 minuts walking test. [ Time Frame: Change from Baseline in gait speed at 6 months follow up. ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Fugl Meyer (lower limb section) [ Time Frame: Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 90
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)
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.
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)
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.
Other: Ground treatment
The practice will included ground walking therapy s for 40 min with therapist support.
Other Name: Physiotherapy treatment.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678547

Contacts
Contact: Patrizio Sale, MD patrizio.sale@gmail.com
Contact: Marco Franceschini, MD marco.franceschini@sanraffaele.it

Locations
Italy
San Raffaele Cassino Recruiting
Cassino, Italy
Contact: Patrizio Sale, MD       patrizio.sale@gmail.com   
Sub-Investigator: Patrizio Sale, MD         
Principal Investigator: De Pandis Maria Francesca, MD         
IRCCS San Raffaele Pisana Recruiting
Rome, Italy, 00166
Contact: Patrizo Sale, MD       patrizio.sale@gmail.com   
Principal Investigator: Patrizio Sale, MD         
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Patrizio Sale, MD IRCCS San Raffaele Pisana Rome Italy
  More Information

No publications provided

Responsible Party: Patrizio Sale , MD, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01678547     History of Changes
Other Study ID Numbers: RoboSTROKE
Study First Received: August 31, 2012
Last Updated: February 12, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS San Raffaele:
Stroke
Robot
Treatment
Rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Nervous System Diseases
Gait Disorders, Neurologic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014