Gait Disorders, NeurologicNCT05811494
Effectiveness of Multiple Robotic Gait-Devices for Improving Walking Ability in Subacute Stroke Patients
A study testing Lexo, Lokomat and C-Mill in people with Gait Disorders, Neurologic and Stroke, run by Neuron, Spain at 5 sites in Spain.
Trial summary
The purpose of this study is to know the effectiveness of different robotic devices for gait rehabilitation in stroke patients Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Gait Disorders, Neurologic, Stroke, Walking
- What is being tested?
- Lexo, Lokomat and C-Mill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesSpain
- Study dates
- 15 Mar 2023to 1 Aug 2024
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having suffered an ischaemic or haemorrhagic stroke with less than 6 months of evolution at the start of the study
- Presenting gait deficits compatible with a level between 2 and 3 of the functional category of gait (FAC)
- More than 20 seconds in the Time Up and Go test
- Less than 3 points on the Reisberg Global Deterioration Scale (GDS-R).
Who cannot join
- Presenting any type of specific contraindication to use the robotic device to be used with respect to their group. Thus, those patients who present a limitation in the range of movement in the hip of more than 0º of extension and 40º of flexion, in the knee of less than 30º of flexion and in the ankle of less than 0º of dorsal flexion will not be able to participate in the study.
- Lower limb spasticity greater than 3 on the modified Asworth scale
- Unable to maintain an assisted standing position for more than 5 minutes
- Unable to understand simple commands
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Neuron Chamberí
Madrid, Madrid, 28003
Neuron Mercedes
Madrid, Madrid, 28022
Neuron Habana
Madrid, Madrid, 28023
Neuron Madrid Rio
Madrid, Madrid, 28045
Neuron Valencia
Valencia, 46023
About this study
Official title: Effectiveness of Multiple Robotic Gait-Devices for Improving Walking Ability in Subacute Stroke Patients: a Randomized Controlled Trial
The purpose of this study is to know the effectiveness of different robotic devices for gait rehabilitation in stroke patients
Read the detailed description
Subjects will attend the Neuron rehabilitation clinic on their own to begin a rehabilitation program. After being recruited for the study and signing informed consent the patient will be assessed with the Timed Up and Go Test and 10 Meter Walking Test, and it will be realized a spatio temporal variables analysis with baiobit system and a superficial Electomiografic activity analysis during gait with Noraxon system.
Once the assessment is completed, the participant will receive the treatment assigned at his rehabilitation clinic. The patient will receive 30 minutes of robotic treatment with Lexi, Lokomat, C-Mill or the body-weight support treadmill and 15 minutes of overground walking training between 70-85% of HR max.
Once the treatment period is over, after 25 sessions, the assessment will be carried out again, recording the initial tests in the same order by the same assessors.
- Conditions
- Gait Disorders, Neurologic, Stroke, Walking
- Being tested
- Lexo, Lokomat, C-Mill, Body-weight support treadmill
- Keywords
- Gait-Devices, Robotics, Stroke, Gait
- Medical subject headings
- Gait Disorders, Neurologic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LexoDevice
Lexo is a Robot-Assited Gait device based on an end-effector system that supports the weight of the patient and help him to recover the walking function.
LokomatDevice
Lokomat is a Robot-Assited Gait device based on a fixed exoskeleton that supports the weight of the patient and help him to recover the walking function guiding the hips, knees and feet of the patient while walking.
C-MillDevice
C- Mill is a body weight support treadmill which includes virtual reality. I can provide feedback to the patient, assisting or hindering the gait task.
Body-weight support treadmillDevice
Body-weight support treadmill group will receive the same time and intensity of training like the robotic groups but using the treadmill
| Study group | Role | What they receive |
|---|---|---|
| End-Effector walking training | Experimental | Participants in the End-effector group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of Lexo training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers. Receives: Device: Lexo |
| Fixed Exoskeleton walking training | Experimental | Participants in the fixed-exoskeleton group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of Lokomat training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers. Receives: Device: Lokomat |
| Body-Weight Support treadmill training with augmented reality | Experimental | Participants in the Body-Weight Support treadmill training with augmented reality group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of C-Mill training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers. Receives: Device: C-Mill |
| Body-Weight Support treadmill training | Active comparator | Participants in the Body-Weight Support treadmill training group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of body-weight support treadmill training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers. Receives: Device: Body-weight support treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait speed
The velocity at which the patient is able to cover 6 meters at comfortable speed. It will be measured with the 10 Meter walking test in which the evaluator tells the patient to walk over 10 meters and takes the time required to cover the 6 meters in the middle, leaving the 2 initial and final meter for acceleration and deceleration.
Measured: Change from Baseline in gait speed at 4 weeks
Secondary outcomes (7)
Gait ratio
This refers to the relationship between stride length and gait cadence during walking, and is expressed in mm/step/minute. It represents the tendency of motor stride optimisation to minimise the metabolic cost during walking and has normal values of 6 mm/step/minute in women and 7 mm/step/minute in men with a standard deviation of ±08%. It will be measured using Biobit device.
Measured: Change from Baseline in gait ratio at 4 weeks
Double stance time during the gait cycle
Double stance during gait occurs when both feet are in contact with the ground at the same time. It will be measured using Biobit device
Measured: Change from Baseline in double stance time during the gait cycle at 4 weeks
Percentage of time in stance phase during the gait cycle
The stance phase is the part of each gait cycle that begins at heel strike and ends at toe-off. The stance time is therefore the time between the initial contact and the last contact of a single stride. It will be measured using Biobit device
Measured: Change from Baseline in percentage of time in stance phase during the gait cycle at 4 weeks
Maximal Voluntary Contraction (MVC) of the rectus femurs
Motor unit recruitment capacity of the rectus femoris muscle during maximal contraction. An electrode will be placed in the middle third of the rectus femoris muscle parallel to the muscle fibres and in line with the midline of the patella as described by SENIAM. To carry out the measurement, the patient will be placed in a seated position with the knee at 90º of flexion and in contact with the edge of the stretcher. The patient will be asked to do 2 sets of 10 repetitions at 50% of the MVC as a warm-up and then, after 1 minute rest, the patient will be asked to extend the knee as hard and fast as possible for 3 seconds. This process shall be repeated twice more, leaving 1 minute rest between each contraction, and the measurement with the highest average score in those 3 seconds shall be taken. It will be measured using Noraxon EMG software
Measured: Change from Baseline in MVC of the rectus femurs at 4 weeks
Co-contraction index
It is an indirect measure of muscle metabolic cost during walking. Thus, using the formula provided by Falconer et al ,ICC=(2×EMG antagonist)/((EMG antagonist+EMG agonist)) ×100, and applying it during the different phases of gait (double stance, monopodal stance, second double stance and swing phase), we obtain the ICC of the muscles responsible for flexion and flexion, second double stance and swing phase), we will obtain the ICC of the musculature in charge of knee flexion-extension (rectus femoris and semitendinosus) and of the musculature in charge of plantar and dorsal flexion of the ankle (tibialis anterior and medial gastrocnemius). It will be measured using Norton EMG software
Measured: Change from Baseline in co-contraction index at 4 weeks
Changue in balance
Balance has been described as the capacity of controlling the center of pressures while realizing any task. It will be measured with the Berg Balance Scale
Measured: Change from Baseline in balance at 4 weeks
Change in risk of falling
A fall is defined as an event in which an adult unintentionally loses balance and descends to the ground or other lower surface. It is not related to a medical incident or other overwhelming external force. On the other hand, risk was defined by the World Health Organisation (WHO) as the probability that an undesirable event with respect to an individual's health status will occur. It will be measured by Timed Up and Go Test
Measured: Change from Baseline in risk of falling at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start15 Mar 2023
- Primary completion1 Jun 2024
- Study completion1 Aug 2024
Why it stopped: One of the clinics was closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorders, NeurologicStudies 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
- Model description
- There will be three groups of robotic treatment. One of them will receive the walking training with an End-effector Device (LEXO), another with a fixed exoskeleton (Lokomat), and the last one with a Body-Weight Support Treadmill system with Augmented Reality (C-Mill). Theree will be an experimental group which will receive the walking rehabilitation by using a Treadmill with Body-Weight Support
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuron, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo Lerín Calvo, Neuron, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811494
- Sponsor's protocol ID
- ALC001NR003
- Status last verified
- Jan 2025
- First submitted
- 29 Mar 2023
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Multiple Robotic Gait-Devices for Improving Walking Ability in Subacute Stroke Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05811494
- Acronym / sponsor ID
- ALC001NR003
- Conditions
- Gait Disorders, Neurologic, Stroke, Walking
- Keywords
- Gait-Devices, Robotics, Stroke, Gait
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: One of the clinics was closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Neuron, SpainUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 13 Apr 2023 (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.
The purpose of this study is to know the effectiveness of different robotic devices for gait rehabilitation in stroke patients
Detailed description
Subjects will attend the Neuron rehabilitation clinic on their own to begin a rehabilitation program. After being recruited for the study and signing informed consent the patient will be assessed with the Timed Up and Go Test and 10 Meter Walking Test, and it will be realized a spatio temporal variables analysis with baiobit system and a superficial Electomiografic activity analysis during gait with Noraxon system.
Once the assessment is completed, the participant will receive the treatment assigned at his rehabilitation clinic. The patient will receive 30 minutes of robotic treatment with Lexi, Lokomat, C-Mill or the body-weight support treadmill and 15 minutes of overground walking training between 70-85% of HR max.
Once the treatment period is over, after 25 sessions, the assessment will be carried out again, recording the initial tests in the same order by the same assessors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- There will be three groups of robotic treatment. One of them will receive the walking training with an End-effector Device (LEXO), another with a fixed exoskeleton (Lokomat), and the last one with a Body-Weight Support Treadmill system with Augmented Reality (C-Mill). Theree will be an experimental group which will receive the walking rehabilitation by using a Treadmill with Body-Weight Support
| Arm | Type | Receives |
|---|---|---|
| End-Effector walking training | Experimental | Device: LexoParticipants in the End-effector group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of Lexo training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers. |
| Fixed Exoskeleton walking training | Experimental | Device: LokomatParticipants in the fixed-exoskeleton group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of Lokomat training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers. |
| Body-Weight Support treadmill training with augmented reality | Experimental | Device: C-MillParticipants in the Body-Weight Support treadmill training with augmented reality group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of C-Mill training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers. |
| Body-Weight Support treadmill training | Active comparator | Device: Body-weight support treadmillParticipants in the Body-Weight Support treadmill training group will receive one session per day over 4 weeks of Physical Therapy. This therapy will consist in 30 minutes of body-weight support treadmill training adjusting the assistance/resistance of the device for working in 14-17 in the Borg scale and 70-85% HRmax of the patient, assessed with the Tanaka formula (208-(0,7+Age)) and with the correction of 10 beats less if the patient is taking ß-blockers. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having suffered an ischaemic or haemorrhagic stroke with less than 6 months of evolution at the start of the study
- Presenting gait deficits compatible with a level between 2 and 3 of the functional category of gait (FAC)
- More than 20 seconds in the Time Up and Go test
- Less than 3 points on the Reisberg Global Deterioration Scale (GDS-R).
Key exclusion criteria (4 listed)
- Presenting any type of specific contraindication to use the robotic device to be used with respect to their group. Thus, those patients who present a limitation in the range of movement in the hip of more than 0º of extension and 40º of flexion, in the knee of less than 30º of flexion and in the ankle of less than 0º of dorsal flexion will not be able to participate in the study.
- Lower limb spasticity greater than 3 on the modified Asworth scale
- Unable to maintain an assisted standing position for more than 5 minutes
- Unable to understand simple commands
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 |
|---|---|---|
| LexoLexo is a Robot-Assited Gait device based on an end-effector system that supports the weight of the patient and help him to recover the walking function. | Device | End-Effector walking training |
| LokomatLokomat is a Robot-Assited Gait device based on a fixed exoskeleton that supports the weight of the patient and help him to recover the walking function guiding the hips, knees and feet of the patient while walking. | Device | Fixed Exoskeleton walking training |
| C-MillC- Mill is a body weight support treadmill which includes virtual reality. I can provide feedback to the patient, assisting or hindering the gait task. | Device | Body-Weight Support treadmill training with augmented reality |
| Body-weight support treadmillBody-weight support treadmill group will receive the same time and intensity of training like the robotic groups but using the treadmill | Device | Body-Weight Support treadmill training |
Primary outcome
Change in gait speed
Time frame: Change from Baseline in gait speed at 4 weeks
The velocity at which the patient is able to cover 6 meters at comfortable speed. It will be measured with the 10 Meter walking test in which the evaluator tells the patient to walk over 10 meters and takes the time required to cover the 6 meters in the middle, leaving the 2 initial and final meter for acceleration and deceleration.
7 secondary outcomes
Gait ratio
Time frame: Change from Baseline in gait ratio at 4 weeks
Double stance time during the gait cycle
Time frame: Change from Baseline in double stance time during the gait cycle at 4 weeks
Percentage of time in stance phase during the gait cycle
Time frame: Change from Baseline in percentage of time in stance phase during the gait cycle at 4 weeks
Maximal Voluntary Contraction (MVC) of the rectus femurs
Time frame: Change from Baseline in MVC of the rectus femurs at 4 weeks
Co-contraction index
Time frame: Change from Baseline in co-contraction index at 4 weeks
Changue in balance
Time frame: Change from Baseline in balance at 4 weeks
Change in risk of falling
Time frame: Change from Baseline in risk of falling at 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lexo, Lokomat and C-Mill in people with Gait Disorders, Neurologic and Stroke, run by Neuron, Spain at 5 sites in Spain.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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 withdrawn before enrolling participants, so there are no results.
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 gait speed (time frame: Change from Baseline in gait speed at 4 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 3 Feb 2025.