StrokeRoboSTROKENCT01678547
Robot Walking Rehabilitation in Stroke Patients
A study testing Robot-assisted walking, Treadmill Training and Ground treatment in people with Stroke and Gait Disorders, Neurologic, run by IRCCS San Raffaele Roma at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Gait Disorders, Neurologic
- What is being tested?
- Robot-assisted walking, Treadmill Training and Ground treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesItaly
- Study dates
- Sep 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effect of Robot Assisted Treatment on Gait Performace in Stroke Patients
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.
Read the 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.
- Conditions
- Stroke, Gait Disorders, Neurologic
- Being tested
- Robot-assisted walking, Treadmill Training, Ground treatment
- Keywords
- Stroke, Robot, Treatment, Rehabilitation
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted walkingDevice
Also called G-EO System (Reha Technology AG Switzerland)
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.
Treadmill TrainingDevice
Also called Gait Trainer 3 (Biodex Medical Systems New York)
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.
Ground treatmentOther
Also called Physiotherapy treatment.
The practice will included ground walking therapy s for 40 min with therapist support.
| Study group | Role | What they receive |
|---|---|---|
| Robot G-EO | Experimental | 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. Receives: Device: Robot-assisted walking |
| Treadmill Training | Active comparator | 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. Receives: Device: Treadmill Training |
| Ground treatment | Active comparator | 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. Receives: Other: Ground treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from Baseline in gait speed at 6 months follow up.
Secondary outcomes (5)
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).
Measured: Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.
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).
Measured: Change from Baseline in Borg scale at 6 months follow up.
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).
Measured: baseline, weekly during intervention, 6 months follow up
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).
Measured: Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.
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).
Measured: Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michela Goffredo, BME, Principal investigator, IRCCS San Raffaele Rome Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678547
- Sponsor's protocol ID
- RP 19/12
- Acronym
- RoboSTROKE
- Status last verified
- Apr 2024
- First submitted
- 31 Aug 2012
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Robot Assisted Treatment on Gait Performace in Stroke Patients
- ClinicalTrials.gov ID
- NCT01678547
- Acronym / sponsor ID
- RoboSTROKE / RP 19/12
- Conditions
- Stroke, Gait Disorders, Neurologic
- Keywords
- Stroke, Robot, Treatment, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 28 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robot G-EO | Experimental | Device: Robot-assisted walkingEach 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. |
| Treadmill Training | Active comparator | Device: Treadmill TrainingEach 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 treatment | Active comparator | Other: Ground treatmentGround 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted walkingAlso: G-EO System (Reha Technology AG Switzerland)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. | Device | Robot G-EO |
| Treadmill TrainingAlso: Gait Trainer 3 (Biodex Medical Systems New York)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. | Device | Treadmill Training |
| Ground treatmentAlso: Physiotherapy treatment.The practice will included ground walking therapy s for 40 min with therapist support. | Other | Ground treatment |
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).
5 secondary outcomes
Fugl Meyer (lower limb section)
Time frame: Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.
Borg scale
Time frame: Change from Baseline in Borg scale at 6 months follow up.
Gait Parameters with EMG
Time frame: baseline, weekly during intervention, 6 months follow up
Functional Ambulation Classification
Time frame: Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.
Walk Handicap Scale (WHS)
Time frame: Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michela Goffredo, BME principal investigator
IRCCS San Raffaele Rome Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted walking, Treadmill Training and Ground treatment in people with Stroke and Gait Disorders, Neurologic, run by IRCCS San Raffaele Roma at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minuts walking test. (time frame: Change from Baseline in gait speed at 6 months follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.