StrokeNCT04494685
Effects of Robotic Rehabilitation in Post-Stroke Patients
A study testing Intervention group (Robotic rehabilitation) in people with Stroke, run by Federal University of Health Science of Porto Alegre.
Trial summary
This study aims to evaluate the effect of robotic rehabilitation through training on a robot-assisted orthostatic board and neuromuscular electrical stimulation (NMES) on functionality in post-stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Intervention group (Robotic rehabilitation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 31 Dec 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical diagnosis of ischemic stroke, in the subacute phase (after 48 hours);
- To present hemiparesis or muscle weakness defined by the Medical Research Council (MRC) score;
- To understand simple commands and being able to report signs of discomfort.
Who cannot join
- Severe psychomotor agitation;
- Recent acute myocardial infarction (24 hours) and/or uncontrolled arrhythmias;
- Intracranial hypertension (PIC> 20mmHg);
- Uncontrolled hypertension (PAS> 230 mmHg and PAD> 120 mmHg) or PAM <60 mmHg;
- Decompensated heart failure;
- To present important hemodynamic changes during training;
Show all 14Show fewer
- Peripheral vascular disease in the lower limb such as untreated deep vein thrombosis;
- Unconsolidated fractures or severe joint pain;
- Feverish state;
- Smokers;
- Epidermal lesions on the thighs that make it impossible to place self-adhesive electrodes for electrical stimulation;
- Pre-existing neuromuscular disease;
- Signs of rhabdomyolysis;
- Pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Robotic Rehabilitation in Post-Stroke Patients: A Randomized Controlled Trial
This study aims to evaluate the effect of robotic rehabilitation through training on a robot-assisted orthostatic board and neuromuscular electrical stimulation (NMES) on functionality in post-stroke patients. In this randomized controlled trial the patients will be allocated to a control group (which will receive conventional physiotherapy) or or to intervention group (which will receive conventional physiotherapy and robotic rehabilitation). Interventions will occur every day in the hospital phase and three times/week after discharge, totaling 18 sessions.The groups will be evaluated prior to any physiotherapy intervention, in the 10h session and at the end of six weeks of treatment (or 18 sessions).The following outcomes will be measured: functionality, peripheral muscle strength, muscle architecture and echogenicity, spasticity, cardiorespiratory repercussions, mobility, disability and dependence, quality of life and time of hospital stay.
- Conditions
- Stroke
- Being tested
- Intervention group (Robotic rehabilitation), Control group (Conventional physiotherapy)
- Keywords
- Stroke, Robotics, Electric stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group (Robotic rehabilitation)Device
Also called Erigo®
Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland). The training protocol has a progression of the board inclination up to 90º associated with flexion/extension movements of the knees and hips, with time evolution of up to 40 minutes. Such equipment is associated with electrostimulation of the quadriceps, hamstrings, sural triceps and anterior tibialis.
Control group (Conventional physiotherapy)Other
Knee and hip flexion and extension movements, hip adduction, and abduction, respecting the articular physiology of each joint. Weight transfer will also be performed in the sitting and standing position, mini squat, and gait training. All exercises will have a total of 10 repetitions in three sets. In the end, stretching of the upper and lower limbs will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Robotic rehabilitation | Experimental | Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland). Receives: Device: Intervention group (Robotic rehabilitation) |
| Conventional physiotherapy | Active comparator | The protocol will be based on lower limb exercises, aiming at maintaining and gaining muscle strength through passive, assisted or active mobilization, when possible, on the affected side. Receives: Other: Control group (Conventional physiotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionality
The change in functionality will be assessed using the Fugl-Meyer Scale. This scale consists of six domains: range of motion, pain, sensitivity, motor function of the upper and lower extremities, balance, coordination and speed. The score for each item ranges from 0 to 2, where 0 = cannot be performed; 1 = partially accomplished; 2 = completely accomplished. The total score ranges from 0 to 266 points and the higher the score the better the functionality.
Measured: Baseline, after 3 weeks and after 6 weeks
Secondary outcomes (14)
Muscle strength
The change in muscle strength will be assessed by the Medical Research Council (MRC) scale and by test of maximum repetition (1RM)
Measured: Baseline, after 3 weeks and after 6 weeks.
Quadriceps muscle thickness
The change in quadriceps muscle thickness will be evaluated for the acquisition of ultrasound images using a high resolution ultrasound device (Vivid-i, GE, USA). In order to verify the thickness of the muscle, the distance between the superficial and deep aponeurosis is measured.The thickness is given in centimeters.
Measured: Baseline and after 6 weeks
Echogenicity of the rectus femoris muscle
The change in echogenicity will be evaluated for the acquisition of ultrasound images of the rectus femoris muscle using a high resolution ultrasound device (Vivid-i, GE, USA). To check the echogenicity of the rectus femoris an image of the cross-sectional area of the muscle will be taken. The echogenicity measurement is given in an arbitrary unit.
Measured: Baseline and after 6 weeks
Spasticity
The change in spasticity will be assessed by the Modified Ashworth Scale. This scale consists of an ordinal classification of 5 points for grading the resistance found during passive stretching, with 0 indicating normal muscle tone and 4 severe increase in tone. The higher the score, the greater the spasticity.
Measured: Baseline, after after 3 weeks and after 6 weeks
Mobility
The change in mobility will be assessed using the Timed Up and Go test (TUG), which will be associated with an inertial sensor
Measured: After 3 weeks and after 6 weeks
Disability and dependence
The change in disability and dependency will be assessed using the Modified Rankin Scale. This instrument has 6 scores, where: 0 = asymptomatic; 1 = symptoms without disabilities; 2 = mild disability; 3 = moderate disability; 4 = moderate to severe disability; 5 = severe disability and 6 = death. The higher the score, the greater the degree of disability and dependence.
Measured: Baseline and after 6 weeks
Quality of life indicator
The change in quality of life will be assessed using the EuroQol-5D questionnaire. This is a generic instrument that assesses mobility, personal care, usual activities, pain and anxiety/depression. It allows to generate a global index of the value of an individual's health status. The number 1 indicates the best state of health (perfect health) and 0 the worst state of health (death).
Measured: Baseline and after 6 weeks
Heart rate
Heart rate will be assessed by pulse oximetry
Measured: From the 1st to the 18th day/session
Peripheral arterial oxygen saturation
Peripheral arterial oxygen saturation will be assessed by pulse oximetry
Measured: From the 1st to the 18th day/session
Systolic blood pressure
Systolic blood pressure will be assessed through sphygmomanometer
Measured: From the 1st to the 18th day/session
Diastolic blood pressure
Diastolic blood pressure will be assessed through sphygmomanometer
Measured: From the 1st to the 18th day/session
Muscle pain
Pain perception will be assessed using the Visual Analog Scale. This scale ranges from 0 to 10, where 0 indicates no pain and 10 maximum pain.
Measured: From the 1st to the 18th day/session
Lower limb fatigue
Lower limb fatigue will be assessed by Borg effort subjective perception scale. This scale ranges from 0 to 10, where 0 indicates no effort or fatigue and 10 indicates maximum effort.
Measured: From the 1st to the 18th day/session
Time of hospital stay
The days between admission and hospital discharge will be counted
Measured: From the 1st to the last day of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre
- Investigators
- Rodrigo DM Plentz, PhD, Principal investigator, Federal University of Health Sciences of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494685
- Sponsor's protocol ID
- Stroke_ERIGO
- Status last verified
- Jul 2020
- First submitted
- 29 May 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Robotic Rehabilitation in Post-Stroke Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04494685
- Acronym / sponsor ID
- Stroke_ERIGO
- Conditions
- Stroke
- Keywords
- Stroke, Robotics, Electric stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 31 Jul 2020 (actual)
- 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.
This study aims to evaluate the effect of robotic rehabilitation through training on a robot-assisted orthostatic board and neuromuscular electrical stimulation (NMES) on functionality in post-stroke patients. In this randomized controlled trial the patients will be allocated to a control group (which will receive conventional physiotherapy) or or to intervention group (which will receive conventional physiotherapy and robotic rehabilitation). Interventions will occur every day in the hospital phase and three times/week after discharge, totaling 18 sessions.The groups will be evaluated prior to any physiotherapy intervention, in the 10h session and at the end of six weeks of treatment (or 18 sessions).The following outcomes will be measured: functionality, peripheral muscle strength, muscle architecture and echogenicity, spasticity, cardiorespiratory repercussions, mobility, disability and dependence, quality of life and time of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic rehabilitation | Experimental | Device: Intervention group (Robotic rehabilitation)Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland). |
| Conventional physiotherapy | Active comparator | Other: Control group (Conventional physiotherapy)The protocol will be based on lower limb exercises, aiming at maintaining and gaining muscle strength through passive, assisted or active mobilization, when possible, on the affected side. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical diagnosis of ischemic stroke, in the subacute phase (after 48 hours);
- To present hemiparesis or muscle weakness defined by the Medical Research Council (MRC) score;
- To understand simple commands and being able to report signs of discomfort.
Key exclusion criteria (14 listed)
- Severe psychomotor agitation;
- Recent acute myocardial infarction (24 hours) and/or uncontrolled arrhythmias;
- Intracranial hypertension (PIC> 20mmHg);
- Uncontrolled hypertension (PAS> 230 mmHg and PAD> 120 mmHg) or PAM <60 mmHg;
- Decompensated heart failure;
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 |
|---|---|---|
| Intervention group (Robotic rehabilitation)Also: Erigo®Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland). The training protocol has a progression of the board inclination up to 90º associated with flexion/extension movements of the knees and hips, with time evolution of up to 40 minutes. Such equipment is associated with electrostimulation of the quadriceps, hamstrings, sural triceps and anterior tibialis. | Device | Robotic rehabilitation |
| Control group (Conventional physiotherapy)Knee and hip flexion and extension movements, hip adduction, and abduction, respecting the articular physiology of each joint. Weight transfer will also be performed in the sitting and standing position, mini squat, and gait training. All exercises will have a total of 10 repetitions in three sets. In the end, stretching of the upper and lower limbs will be performed. | Other | Conventional physiotherapy |
Primary outcome
Functionality
Time frame: Baseline, after 3 weeks and after 6 weeks
The change in functionality will be assessed using the Fugl-Meyer Scale. This scale consists of six domains: range of motion, pain, sensitivity, motor function of the upper and lower extremities, balance, coordination and speed. The score for each item ranges from 0 to 2, where 0 = cannot be performed; 1 = partially accomplished; 2 = completely accomplished. The total score ranges from 0 to 266 points and the higher the score the better the functionality.
14 secondary outcomes
Muscle strength
Time frame: Baseline, after 3 weeks and after 6 weeks.
Quadriceps muscle thickness
Time frame: Baseline and after 6 weeks
Echogenicity of the rectus femoris muscle
Time frame: Baseline and after 6 weeks
Spasticity
Time frame: Baseline, after after 3 weeks and after 6 weeks
Mobility
Time frame: After 3 weeks and after 6 weeks
Disability and dependence
Time frame: Baseline and after 6 weeks
Quality of life indicator
Time frame: Baseline and after 6 weeks
Heart rate
Time frame: From the 1st to the 18th day/session
Peripheral arterial oxygen saturation
Time frame: From the 1st to the 18th day/session
Systolic blood pressure
Time frame: From the 1st to the 18th day/session
Diastolic blood pressure
Time frame: From the 1st to the 18th day/session
Muscle pain
Time frame: From the 1st to the 18th day/session
Lower limb fatigue
Time frame: From the 1st to the 18th day/session
Time of hospital stay
Time frame: From the 1st to the last day of hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Rodrigo DM Plentz, PhD principal investigator
Federal University of Health Sciences of Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group (Robotic rehabilitation) in people with Stroke, run by Federal University of Health Science of Porto Alegre.
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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo DM Plentz, PhD (+555191131651, roplentz@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionality (time frame: Baseline, after 3 weeks and after 6 weeks). 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 31 Jul 2020.