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Robot Walking Rehabilitation in Stroke Patients (RoboSTROKE)

Primary Purpose

Stroke, Gait Disorders, Neurologic

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Robot-assisted walking
Treadmill Training
Ground treatment
Sponsored by
IRCCS San Raffaele Roma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Robot, Treatment, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Raffaele Cassino
  • IRCCS San Raffaele Roma

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Robot G-EO

Treadmill Training

Ground treatment

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

6 minuts walking test.
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)
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
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
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
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)
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).

Full Information

First Posted
August 31, 2012
Last Updated
July 5, 2023
Sponsor
IRCCS San Raffaele Roma
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1. Study Identification

Unique Protocol Identification Number
NCT01678547
Brief Title
Robot Walking Rehabilitation in Stroke Patients
Acronym
RoboSTROKE
Official Title
Effect of Robot Assisted Treatment on Gait Performace in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele Roma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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]: sub-acute and chronic stroke patients robot treatment. sub-acute and chronic patients treadmill treatment. sub-acute and chronic patients ground treatment. The specific aims of this project are: 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; to analyse possible improvements in terms of physiological biomechanical gait through analysis of kinematics , kinetics and EMG evaluation; 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; to evaluate the kinematic, kinetic and EMG quantitative data during selected movements (gait, posture, ) compared with age matched reference data; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Gait Disorders, Neurologic
Keywords
Stroke, Robot, Treatment, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot G-EO
Arm Type
Experimental
Arm Description
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.
Arm Title
Treadmill Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ground treatment
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Robot-assisted walking
Other Intervention Name(s)
G-EO System (Reha Technology AG Switzerland)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Treadmill Training
Other Intervention Name(s)
Gait Trainer 3 (Biodex Medical Systems New York)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Ground treatment
Other Intervention Name(s)
Physiotherapy treatment.
Intervention Description
The practice will included ground walking therapy s for 40 min with therapist support.
Primary Outcome Measure Information:
Title
6 minuts walking test.
Description
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).
Time Frame
Change from Baseline in gait speed at 6 months follow up.
Secondary Outcome Measure Information:
Title
Fugl Meyer (lower limb section)
Description
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).
Time Frame
Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.
Title
Borg scale
Description
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).
Time Frame
Change from Baseline in Borg scale at 6 months follow up.
Title
Gait Parameters with EMG
Description
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).
Time Frame
baseline, weekly during intervention, 6 months follow up
Title
Functional Ambulation Classification
Description
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).
Time Frame
Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.
Title
Walk Handicap Scale (WHS)
Description
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).
Time Frame
Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michela Goffredo, BME
Organizational Affiliation
IRCCS San Raffaele Rome Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Raffaele Cassino
City
Cassino
Country
Italy
Facility Name
IRCCS San Raffaele Roma
City
Rome
ZIP/Postal Code
00166
Country
Italy

12. IPD Sharing Statement

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Robot Walking Rehabilitation in Stroke Patients

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