Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)NCT05138211
Effects of Unilateral Robotic Assistance on Compensation Strategies and Muscular Activity During Hemiparetic Gait
A study testing Exoskeleton assisted gait on a treadmill in people with Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis), run by Spanish National Research Council at 1 site in Spain.
Trial summary
Hemiparetic gait is characterized by strong asymmetries that could severely affect the quality of life of stroke survivors. This asymmetry is due to motor deficits in the paretic leg and the resulting compensations in the non-paretic limb. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
- What is being tested?
- Exoskeleton assisted gait on a treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 18 Oct 2021to 30 Apr 2022
- 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
None listed.
Who cannot join
- Acute musculoskeletal diseases
- Peripheral vascular diseases
- Acute cardiopulmonary diseases
- Acute neurological diseases
- Excessive spasticity in any joint of the lower limb (Ashworth scale> 2)
- Joint mobility restriction of lower limb joints due to any cause
- Pain due to impaired mobility of the lower limb
- Inability to use robotic exoskeleton prototypes due to his/her health condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Evolution of Compensatory Strategies and Muscular Response in Hemiparetic Post-stroke Gait Due to Unilateral Robotic Assistance
Hemiparetic gait is characterized by strong asymmetries that could severely affect the quality of life of stroke survivors. This asymmetry is due to motor deficits in the paretic leg and the resulting compensations in the non-paretic limb.
In this study, the investigators aim to evaluate the effect of actively promoting gait symmetry in hemiparetic patients by assessing the motion and muscular activity of both paretic and non-paretic lower limbs. To this end, the investigators use a unilateral active Knee-Ankle-Foot Orthosis able to assist the paretic limb of hemiparetic patients during gait.
Read more
The system is able to synchronize its action with the movement of the unassisted joints, promoting a natural and intuitive interaction. The device generates assistance to induce a healthy gait pattern on the paretic leg.
The hypothesis is that a proper and natural interaction between the user and the exoskeleton would enable the patients to consider the robot action as a part of their own gait capability, improving their gait quality as consequence. Hemiparetic asymmetry is not only due to impairments in the affected limb, but also it is the consequence of biomechanical compensatory mechanisms that might arose in the non-paretic leg. The aim of this study is to assess the adaptation process of the subject to the exoskeleton assistance, and to evaluate the effects of such human-robot interaction in both paretic and non-paretic legs.
Read the detailed description
- Materials: The investigators have developed a Knee-Ankle-Foot orthosis (KAFO) composed of two joints aligned to the knee and ankle of the user. The length of its bars and the positions of its braces can be tailored to the anthropometry of different users. The knee joint is actuated by a DC brushless motor EC-60 flat 408057 (Maxon ag, Switzerland) coupled with a harmonic drive CSD-20-160-2AGR (Harmonic Drive LLC, EE.UU.). The transmission ratio of 1:60 of this system enables the application of a mean torque of 35Nm. The ankle joint of the prototype remains non-actuated and unlimited, enabling its free movement in the sagittal plane. The total weight of the KAFO is about 4kg.
The prototype is equipped with sensors that provide information on system variables that are used for its control in real-time, such as the flexion angle of the robot joint or the interaction torque between user and robot. In addition, the gait kinematic of the user is measured by Inertial Measurement Units (IMUs) and the contact of both feet with the floor by Force Sensing Resistors (FSRs).
The system uses an Adaptive Frequency Oscillator to estimate the continuous gait phase of the contralateral limb and synchronically assists the paretic leg by inducing a healthy gait pattern. The action of the robot depends on the gait phase of the assisted leg: during the stance phase, the robot reinforces the limb so the system composed of the leg and the exoskeleton can load the user's weight and not collapse, while during the swing phase the robot guides the limb's movement according to the Assisted-As-Needed (AAN) paradigm creating a force tunnel around the prescribed trajectory.
- Procedures:
The experimental protocol is divided in three sessions. During all of them, the patient will walk on a treadmill commanded by the physiotherapist while wearing a safety harness to avoid falls and while wearing the robotic exoskeleton in the paretic leg. During the second and third sessions, electromyography will also be acquired by using surface electrodes (Trigno System, Delsys Inc.) and according to the SENIAM guidelines. The muscle activity of Rectus Femoris, Biceps Femoris Long Head, Tibialis Anterior and Medial Gastrocnemius of both legs will be measured through this method. Each experimental session is described next:
- - Training session: The patient will wear the robotic exoskeleton to familiarize with the action of the device. Comfortable and maximum velocities will be identified for each subject.
- - Ramp Velocity Session: the session will be divided into five trials: (a) Pre, the patient will not wear the device; (b) Free, the patient will wear the robot but it is mechanically decoupled so it will enable the free knee movement; (c) Active, the robot will assist the gait until 75% maximum gait velocity ; (d) MaxActive, the robot will assist the gait until maximum gait velocity ; and (e) Post, the patient will repeat the Pre condition. Velocity will increase from a comfortable velocity to the maximum and then come back to the comfortable one.
- - Random Velocity session: the session will be divided into the same trials than the Ramp Velocity Session.
The difference between RampVel and RandomVel sessions will be the sequence of gait speeds at which the patient will walk. During RampVel, five velocity steps will be defined from comfortable to maximum velocity with or without exo (depending on the trial) and coming back to comfortable velocity. During RandomVel, the same range of velocity will be used, but defining five steps in the whole range and setting them in a random order. In both sessions, each gait speed step will last one minute, therefore, all trials will last five minutes. Trials Free, Active and MaxActive will be also randomly ordered in each session.
Between trials, patients will rest during 10 minutes to avoid summation effects. Each session will occur in different days, leaving 1 or 2 days in between.
- Intervention providers A physiotherapist and an engineer will be present during the trials. The first will be responsible of assessing the basal gait of the subjects and evaluating his/her state while the assistance is provided. The engineer will be responsible of managing the device and recording the data.
Both researchers monitor fidelity to the intervention by direct supervision.
- Modes of delivery The protocol is provided to one participant at a time. Each patient completes the protocol once.
- Location Hospital Beata María Ana (Madrid, Spain)
- Tailoring and modifications The protocol remains unaltered across applications. The only adaptation to patients is the choice of the comfortable and maximum gait speeds for the trials.
- Being tested
- Exoskeleton assisted gait on a treadmill
- Keywords
- Hemiparetic Gait, Robotic Knee Exoskeleton
- Medical subject headings
- Paresis, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exoskeleton assisted gait on a treadmillDevice
The experimental protocol is divided in three sessions. During all of them, the patient will walk on a treadmill for 6 minutes while wearing a safety harness and the robotic exoskeleton in the paretic leg.
- - Training session: The patient will wear the robotic exoskeleton to familiarize with the action of the device.
- - Ramp Velocity Session: the session will be divided into five trials: (a) Pre, the patient will not wear the device; (b) Free, the patient will wear the robot but it is mechanically decoupled so it will enable the free knee movement; (c) Active, the robot will assist the gait until 75% maximum gait velocity ; (d) MaxActive, the robot will assist the gait until maximum gait velocity ; and (e) Post, the patient will repeat the Pre condition. Velocity will increase from comfortable velocity to the maximum and then come back to the comfortable one.
- - Random Velocity session: the session will be divided into the same trials than the Ramp Velocity Session.
| Study group | Role | What they receive |
|---|---|---|
| Hemiparetic patients | Experimental | Patients with hemiparetic gait who will be assisted by the exoskeleton action Receives: Device: Exoskeleton assisted gait on a treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symmetry of knee flexion/extension kinematics
The joint motion will be measured by Inertial Sensors
Measured: During the intervention
Symmetry of Integrated EMG in Rectus Femoris
The muscle activity data will be acquired by EMG sensors according to the SENIAM guidelines
Measured: During the intervention
Symmetry of Integrated EMG in Biceps Femoris Long Head
The muscle activity data will be acquired by EMG sensors according to the SENIAM guidelines
Measured: During the intervention
Symmetry of Integrated EMG in Tibialis Anterior
The muscle activity data will be acquired by EMG sensors according to the SENIAM guidelines
Measured: During the intervention
Symmetry of Integrated EMG in Medial Gastrocnemius
The muscle activity data will be acquired by EMG sensors according to the SENIAM guidelines
Measured: During the intervention
Secondary outcomes (2)
Symmetry of step time
Floor contact events are detected by FSRs
Measured: During the intervention
Symmetry of step length
Thigh and shank kinematics measured by inertial sensors
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start18 Oct 2021
- Primary completion1 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)Studies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish National Research Council
- Sponsor type
- Other government
- Collaborators
- Hospital Beata María Ana
- Responsible party
- Principal investigator, Julio S. Lora Millan, Spanish National Research Council
- Investigators
- Julio S. Lora-Millan, Principal investigator, Spanish National Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138211
- Sponsor's protocol ID
- REFLEX_HemipareticEMG
- Status last verified
- Oct 2022
- First submitted
- 23 Oct 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Evolution of Compensatory Strategies and Muscular Response in Hemiparetic Post-stroke Gait Due to Unilateral Robotic Assistance
- ClinicalTrials.gov ID
- NCT05138211
- Acronym / sponsor ID
- REFLEX_HemipareticEMG
- Keywords
- Hemiparetic Gait, Robotic Knee Exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Spanish National Research CouncilOther government
- Collaborators
- Hospital Beata María Ana
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 30 Nov 2021 (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.
Hemiparetic gait is characterized by strong asymmetries that could severely affect the quality of life of stroke survivors. This asymmetry is due to motor deficits in the paretic leg and the resulting compensations in the non-paretic limb.
In this study, the investigators aim to evaluate the effect of actively promoting gait symmetry in hemiparetic patients by assessing the motion and muscular activity of both paretic and non-paretic lower limbs. To this end, the investigators use a unilateral active Knee-Ankle-Foot Orthosis able to assist the paretic limb of hemiparetic patients during gait.
The system is able to synchronize its action with the movement of the unassisted joints, promoting a natural and intuitive interaction. The device generates assistance to induce a healthy gait pattern on the paretic leg.
The hypothesis is that a proper and natural interaction between the user and the exoskeleton would enable the patients to consider the robot action as a part of their own gait capability, improving their gait quality as consequence. Hemiparetic asymmetry is not only due to impairments in the affected limb, but also it is the consequence of biomechanical compensatory mechanisms that might arose in the non-paretic leg. The aim of this study is to assess the adaptation process of the subject to the exoskeleton assistance, and to evaluate the effects of such human-robot interaction in both paretic and non-paretic legs.
Detailed description
- Materials: The investigators have developed a Knee-Ankle-Foot orthosis (KAFO) composed of two joints aligned to the knee and ankle of the user. The length of its bars and the positions of its braces can be tailored to the anthropometry of different users. The knee joint is actuated by a DC brushless motor EC-60 flat 408057 (Maxon ag, Switzerland) coupled with a harmonic drive CSD-20-160-2AGR (Harmonic Drive LLC, EE.UU.). The transmission ratio of 1:60 of this system enables the application of a mean torque of 35Nm. The ankle joint of the prototype remains non-actuated and unlimited, enabling its free movement in the sagittal plane. The total weight of the KAFO is about 4kg.
The prototype is equipped with sensors that provide information on system variables that are used for its control in real-time, such as the flexion angle of the robot joint or the interaction torque between user and robot. In addition, the gait kinematic of the user is measured by Inertial Measurement Units (IMUs) and the contact of both feet with the floor by Force Sensing Resistors (FSRs).
The system uses an Adaptive Frequency Oscillator to estimate the continuous gait phase of the contralateral limb and synchronically assists the paretic leg by inducing a healthy gait pattern. The action of the robot depends on the gait phase of the assisted leg: during the stance phase, the robot reinforces the limb so the system composed of the leg and the exoskeleton can load the user's weight and not collapse, while during the swing phase the robot guides the limb's movement according to the Assisted-As-Needed (AAN) paradigm creating a force tunnel around the prescribed trajectory.
- Procedures:
The experimental protocol is divided in three sessions. During all of them, the patient will walk on a treadmill commanded by the physiotherapist while wearing a safety harness to avoid falls and while wearing the robotic exoskeleton in the paretic leg. During the second and third sessions, electromyography will also be acquired by using surface electrodes (Trigno System, Delsys Inc.) and according to the SENIAM guidelines. The muscle activity of Rectus Femoris, Biceps Femoris Long Head, Tibialis Anterior and Medial Gastrocnemius of both legs will be measured through this method. Each experimental session is described next:
- - Training session: The patient will wear the robotic exoskeleton to familiarize with the action of the device. Comfortable and maximum velocities will be identified for each subject.
- - Ramp Velocity Session: the session will be divided into five trials: (a) Pre, the patient will not wear the device; (b) Free, the patient will wear the robot but it is mechanically decoupled so it will enable the free knee movement; (c) Active, the robot will assist the gait until 75% maximum gait velocity ; (d) MaxActive, the robot will assist the gait until maximum gait velocity ; and (e) Post, the patient will repeat the Pre condition. Velocity will increase from a comfortable velocity to the maximum and then come back to the comfortable one.
- - Random Velocity session: the session will be divided into the same trials than the Ramp Velocity Session.
The difference between RampVel and RandomVel sessions will be the sequence of gait speeds at which the patient will walk. During RampVel, five velocity steps will be defined from comfortable to maximum velocity with or without exo (depending on the trial) and coming back to comfortable velocity. During RandomVel, the same range of velocity will be used, but defining five steps in the whole range and setting them in a random order. In both sessions, each gait speed step will last one minute, therefore, all trials will last five minutes. Trials Free, Active and MaxActive will be also randomly ordered in each session.
Between trials, patients will rest during 10 minutes to avoid summation effects. Each session will occur in different days, leaving 1 or 2 days in between.
- Intervention providers A physiotherapist and an engineer will be present during the trials. The first will be responsible of assessing the basal gait of the subjects and evaluating his/her state while the assistance is provided. The engineer will be responsible of managing the device and recording the data.
Both researchers monitor fidelity to the intervention by direct supervision.
- Modes of delivery The protocol is provided to one participant at a time. Each patient completes the protocol once.
- Location Hospital Beata María Ana (Madrid, Spain)
- Tailoring and modifications The protocol remains unaltered across applications. The only adaptation to patients is the choice of the comfortable and maximum gait speeds for the trials.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemiparetic patients | Experimental | Device: Exoskeleton assisted gait on a treadmillPatients with hemiparetic gait who will be assisted by the exoskeleton action |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Acute musculoskeletal diseases
- Peripheral vascular diseases
- Acute cardiopulmonary diseases
- Acute neurological diseases
- Excessive spasticity in any joint of the lower limb (Ashworth scale> 2)
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 |
|---|---|---|
| Exoskeleton assisted gait on a treadmillThe experimental protocol is divided in three sessions. During all of them, the patient will walk on a treadmill for 6 minutes while wearing a safety harness and the robotic exoskeleton in the paretic leg. 1. - Training session: The patient will wear the robotic exoskeleton to familiarize with the action of the device. 2. - Ramp Velocity Session: the session will be divided into five trials: (a) Pre, the patient will not wear the device; (b) Free, the patient will wear the robot but it is mechanically decoupled so it will enable the free knee movement; (c) Active, the robot will assist the gait until 75% maximum gait velocity ; (d) MaxActive, the robot will assist the gait until maximum gait velocity ; and (e) Post, the patient will repeat the Pre condition. Velocity will increase from comfortable velocity to the maximum and then come back to the comfortable one. 3. - Random Velocity session: the session will be divided into the same trials than the Ramp Velocity Session. | Device | Hemiparetic patients |
Primary outcome
Symmetry of knee flexion/extension kinematics
Time frame: During the intervention
The joint motion will be measured by Inertial Sensors
Symmetry of Integrated EMG in Rectus Femoris
Time frame: During the intervention
The muscle activity data will be acquired by EMG sensors according to the SENIAM guidelines
Symmetry of Integrated EMG in Biceps Femoris Long Head
Time frame: During the intervention
The muscle activity data will be acquired by EMG sensors according to the SENIAM guidelines
Symmetry of Integrated EMG in Tibialis Anterior
Time frame: During the intervention
The muscle activity data will be acquired by EMG sensors according to the SENIAM guidelines
Symmetry of Integrated EMG in Medial Gastrocnemius
Time frame: During the intervention
The muscle activity data will be acquired by EMG sensors according to the SENIAM guidelines
2 secondary outcomes
Symmetry of step time
Time frame: During the intervention
Symmetry of step length
Time frame: During the intervention
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 26 Oct 2022.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.
Related trials for Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
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Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
Stroke, Acute, Stroke, Ischemic
Recruiting
Isokinetic Strength Training in Hemiparetic Patient With Knee Extension Thrust
Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis), Gait Disorder
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.
Julio S. Lora-Millan principal investigator
Spanish National Research Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton assisted gait on a treadmill in people with Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis), run by Spanish National Research Council at 1 site 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 0 inclusion and 8 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 26 Oct 2022. 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 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 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?
Symmetry of knee flexion/extension kinematics (time frame: During the intervention). 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 26 Oct 2022.