Ischemic StrokeNCT04497545
The Influence of EMG-triggered Robotic Movement on Function and Mobility of Stroke Patients
A study testing Luna EMG and lower limb rotor in people with Ischemic Stroke, run by EGZOTech at 1 site in Poland.
Trial summary
Rehabilitation of lower limbs after a stroke supported by robots aims to return to independence and minimize disability caused by the incident, but the results have been mixed. Objective of the study was to assess the changes in gait capabilities, muscle tone and daily activities in patients after a recent stroke who… Read more about this study
- Who is it for?
- Ages 29 to 91 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Luna EMG and lower limb rotor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 sitePoland
- Study dates
- 24 Feb 2019to 13 Jan 2020
- 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 29 to 91 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic stroke,
- not later than 6 months ago,
- muscle strength of extensors and knee flexors on the Lovetta scale below 3,
- functional disorders of the lower limb,
- patient's condition allowing full understanding of commands
- continued/uninterrupted rehabilitation process for 28 days
Who cannot join
- cognitive impairment-lack of or poor cooperation between the patient and the therapist,
- stroke (more than 6 months after the incident),
- unstable clinical condition,
- muscle strength of knee extensors and flexors on the Lovett scale greater than or equal to 3,
- rigid fixed contractures within the lower limb,
- significant spasticity (Ashworth scale of 3 and above)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of EMG-triggered Robotic Movement on Function and Mobility of Stroke
Rehabilitation of lower limbs after a stroke supported by robots aims to return to independence and minimize disability caused by the incident, but the results have been mixed. Objective of the study was to assess the changes in gait capabilities, muscle tone and daily activities in patients after a recent stroke who underwent a 6-week supervised rehabilitation process using exercises on the LUNA EMG neurorehabilitation robot. A total of 60 participants with impaired motor function and gait after subacute stroke were included in the study. Each patient was randomly assigned to an intervention (robot) or control group (RG or CG). All patients, except standard therapy, underwent 1 session of therapy per day, 5 days a week for 6 weeks. People with RG had 30 minutes of training sessions on the Luna EMG robot, while CG received exercises on the lower limb rotor. Patients were evaluated before the start of the study, and then after 2, 4 and 6 weeks of therapy using the Ashworth scale, Rivermead mobility index (RMI), Repty functional index, Time Up and Go test (TUG) and muscle circumference on the thigh.
- Conditions
- Ischemic Stroke
- Being tested
- Luna EMG, lower limb rotor
- Keywords
- stroke,, rehabilitation,, EMG-triggered rehabilitation,, robotic-assisted movement,, gait
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luna EMGDevice
The duration of the overall therapeutic intervention in both groups will be the same.
lower limb rotorDevice
The duration of the overall therapeutic intervention in both groups will be the same.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | A four-week rehabilitation program (Monday to Friday) involving the hour of individual therapy and 30 minutes of therapy on the Luna EMG device. Receives: Device: Luna EMG |
| Control Group | Other | A four-week rehabilitation program (Monday to Friday) involving one hour of individual therapy and 30 minutes on lower limb rotor Receives: Device: lower limb rotor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Timed up and go test results
the test is performed from a sitting position. The patient on command is to get up from the chair to walk a distance of 3 meters, then turn back and sit on the chair
Measured: baseline, after 4 weeks, after 6 weeks
Change in Ashworth Scale results
Measurement of resistance during passive knee flexion and extension
Scorse range from 0 to 4, with 5 choices:
Grade 0: No increase in muscle tone. Grade 1: Slight increase in muscle tone, manifested by a catch and release or by minimal.
resistance when the affected part is moved in flexion or extension. Grade 2: More marked increase in muscle tone, but affected part(s) easily moved.
Grade 3: Considerable increase in muscle tone, passive movement difficult. Grade 4: Affected part(s) rigid in flexion or extension. Higher values represent a worse outcome.
Measured: baseline, after 4 weeks, after 6 weeks
Change in Rivermeade Motor Assessment (RMA)
The RMA assess functional mobility following stroke. Gross Function (RMA-Gf) : gait, balance, transfers.
Each item is scored either yes "1" or no "0". It is based on Guttman scaling, which presumes that each subsequent item is of a more difficult nature. To advance to the next question, one must score (1) on an item, otherwise the test is stopped.
Measured: baseline, after 4 weeks, after 6 weeks
change in REPTY questionnair results
a scoring scale for evaluation of ADL in hemiplegic patients. The higher score the more independent the patient is (the better)
Measured: baseline, after 4 weeks, after 6 weeks
Change in Tight Circumference
thigh circumferences (5 and 15 centimeters above the patella),
Measured: baseline, after 4 weeks, after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start24 Feb 2019
- Primary completion13 Jan 2020
- Study completion13 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- EGZOTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497545
- Sponsor's protocol ID
- Limanowa Trial
- Status last verified
- Jul 2020
- First submitted
- 29 Jul 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of EMG-triggered Robotic Movement on Function and Mobility of Stroke
- ClinicalTrials.gov ID
- NCT04497545
- Acronym / sponsor ID
- Limanowa Trial
- Conditions
- Ischemic Stroke
- Keywords
- stroke,, rehabilitation,, EMG-triggered rehabilitation,, robotic-assisted movement,, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- EGZOTechIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2019 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 4 Aug 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.
Rehabilitation of lower limbs after a stroke supported by robots aims to return to independence and minimize disability caused by the incident, but the results have been mixed. Objective of the study was to assess the changes in gait capabilities, muscle tone and daily activities in patients after a recent stroke who underwent a 6-week supervised rehabilitation process using exercises on the LUNA EMG neurorehabilitation robot. A total of 60 participants with impaired motor function and gait after subacute stroke were included in the study. Each patient was randomly assigned to an intervention (robot) or control group (RG or CG). All patients, except standard therapy, underwent 1 session of therapy per day, 5 days a week for 6 weeks. People with RG had 30 minutes of training sessions on the Luna EMG robot, while CG received exercises on the lower limb rotor. Patients were evaluated before the start of the study, and then after 2, 4 and 6 weeks of therapy using the Ashworth scale, Rivermead mobility index (RMI), Repty functional index, Time Up and Go test (TUG) and muscle circumference on the thigh.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Luna EMGA four-week rehabilitation program (Monday to Friday) involving the hour of individual therapy and 30 minutes of therapy on the Luna EMG device. |
| Control Group | Other | Device: lower limb rotorA four-week rehabilitation program (Monday to Friday) involving one hour of individual therapy and 30 minutes on lower limb rotor |
Who may qualify
- Ages
- 29 to 91 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ischemic stroke,
- not later than 6 months ago,
- muscle strength of extensors and knee flexors on the Lovetta scale below 3,
- functional disorders of the lower limb,
- patient's condition allowing full understanding of commands
Key exclusion criteria (6 listed)
- cognitive impairment-lack of or poor cooperation between the patient and the therapist,
- stroke (more than 6 months after the incident),
- unstable clinical condition,
- muscle strength of knee extensors and flexors on the Lovett scale greater than or equal to 3,
- rigid fixed contractures within the lower limb,
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 |
|---|---|---|
| Luna EMGThe duration of the overall therapeutic intervention in both groups will be the same. | Device | Study Group |
| lower limb rotorThe duration of the overall therapeutic intervention in both groups will be the same. | Device | Control Group |
Primary outcome
Change in Timed up and go test results
Time frame: baseline, after 4 weeks, after 6 weeks
the test is performed from a sitting position. The patient on command is to get up from the chair to walk a distance of 3 meters, then turn back and sit on the chair
Change in Ashworth Scale results
Time frame: baseline, after 4 weeks, after 6 weeks
Measurement of resistance during passive knee flexion and extension Scorse range from 0 to 4, with 5 choices: Grade 0: No increase in muscle tone. Grade 1: Slight increase in muscle tone, manifested by a catch and release or by minimal. resistance when the affected part is moved in flexion or extension. Grade 2: More marked increase in muscle tone, but affected part(s) easily moved. Grade 3: Considerable increase in muscle tone, passive movement difficult. Grade 4: Affected part(s) rigid in flexion or extension. Higher values represent a worse outcome.
Change in Rivermeade Motor Assessment (RMA)
Time frame: baseline, after 4 weeks, after 6 weeks
The RMA assess functional mobility following stroke. Gross Function (RMA-Gf) : gait, balance, transfers. Each item is scored either yes "1" or no "0". It is based on Guttman scaling, which presumes that each subsequent item is of a more difficult nature. To advance to the next question, one must score (1) on an item, otherwise the test is stopped.
change in REPTY questionnair results
Time frame: baseline, after 4 weeks, after 6 weeks
a scoring scale for evaluation of ADL in hemiplegic patients. The higher score the more independent the patient is (the better)
Change in Tight Circumference
Time frame: baseline, after 4 weeks, after 6 weeks
thigh circumferences (5 and 15 centimeters above the patella),
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luna EMG and lower limb rotor in people with Ischemic Stroke, run by EGZOTech at 1 site in Poland.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Timed up and go test results (time frame: baseline, after 4 weeks, after 6 weeks). The study lists 5 primary outcomes in all. 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 4 Aug 2020.