StrokeNCT05334030
Walking With the EksoNR in Stroke Patients and Healthy Controls: Biomechanical Changes and User Experience.
A study testing High Swing Assistance, Neutral Swing Assistance and High Swing Resistance in people with Stroke and Healthy, run by Vrije Universiteit Brussel.
Trial summary
Further studies are needed to provide more detailed information on the potential effects of robotic gait training in general, as well as on the influence on gait movement patterns in particular. Patient perspectives and feedback contribute to the continuous development of exoskeletal technology. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- What is being tested?
- High Swing Assistance, Neutral Swing Assistance and High Swing Resistance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2022to Dec 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People diagnosed with first-ever stroke (as defined by the WHO);
- Age between 18 and 80 years;
- Time since diagnosis between 1 week and 6 months;
- Functional ambulation category below 3 (meaning a patient who requires intermittent or continuous manual contact to support body weight, maintain balance or assist coordination.);
- Does not meet the Ekso robotic exoskeleton frame limitations (See list below)
- Able to provide written or verbal informed consent.
Who cannot join
- Extensive experience with the use of the EksoNR (more than four training sessions);
- Other neurological or musculoskeletal problems leading to impaired gait (unrelated to their stroke);
- Severe complicating comorbidities (e.g., cardiovascular instability, pulmonary diseases);
- Severe deficits of communication, memory or understanding (25 points or less on the MoCA test);
- And contraindications for EksoNR use (see list below).
- A group of healthy participants within the same age category will be used as controls.
Show all 33Show fewer
- Disabilities leading to impaired gait;
- Severe complicating comorbidities (e.g.: cardiovascular instability, pulmonary diseases);
- Severe deficits of communication, memory or understanding (25 points or less on the MoCA test);
- Contraindications for EksoNR use (see list below).
- Severe concurrent medical conditions: infections, circulatory, heart or lung, pressure sores.
- Severe spasticity (Modified Ashworth 4).
- Unstable spine or unhealed limbs or pelvic fractures.
- Active heterotopic ossification interfering with lower extremity range of motion.
- Significant contractures.
- Psychiatric or cognitive situations that may interfere with the proper operation of the device.
- Cognitive impairments resulting in the inability to follow directions.
- Pregnancy.
- Colostomy.
- Poor skin integrity in areas in contact with the device.
- Decreased standing tolerance due to orthostatic hypotension.
- Range of motion restrictions that would prevent a patient from achieving a normal, reciprocal gait pattern, or would restrict a patient from completing normal sit-to-stand or stand-to-sit transitions: Knee flexion contracture greater than 12° and inability to achieve 0° neutral angle dorsiflexion with knee flexion up to 12°.
- Leg length discrepancy greater than 1.27 cm for thighs or 1.91 cm for lower legs.
- Unresolved deep vein thrombosis.
- Uncontrolled autonomic dysreflexia.
- Lower limb prosthesis.
- Requirements for the use of the EksoNR:
- Weigh 100 kg or less.
- Between 1.5 m and 1.88 m tall.
- Have a standing hip width of 45 cm or less.
- Have a near-normal range of motion in hips, knees, and ankles.
- Able to attain neutral ankle dorsiflexion with <12 degrees of knee flexion contracture.
- Upper leg length discrepancy must be equal to or less than 1.27 cm and lower leg discrepancy equal to or less than 1.91 cm.
Trial locations and contacts
No sites are listed yet.
About this study
Further studies are needed to provide more detailed information on the potential effects of robotic gait training in general, as well as on the influence on gait movement patterns in particular. Patient perspectives and feedback contribute to the continuous development of exoskeletal technology. For these reasons, the main objective of this study is to decipher the relationship between EksoNR's robotic control settings and walking biomechanics in stroke patients and healthy subjects; the second objective is to discover the user experience during the use of EksoNR.
Read the detailed description
Stroke is the leading cause of severe disability in adults resulting in mobility, balance, and coordination deficits. Because of this, walking recovery has a significant impact on stroke patients' quality of life. To improve rehabilitation techniques, robotic exoskeletons are being increasingly used during physiotherapy sessions. The use of robotic exoskeletons enhances conventional poststroke rehabilitation via intense and task-oriented training. To achieve a normal gait pattern, it is essential to restore the correct activation timing of the lower limb muscles.
Designed by Ekso Bionics, EksoNR is the first exoskeleton device to receive FDA clearance for rehabilitation use with patients with acquired brain injury and stroke patients. EksoNR has several settings that can be adapted to have the best user experience possible and to provide individual-specific training. This study is being proposed to better understand the impact of each setting on stroke recovery and user experience. The two key outcomes are 1) to decipher the relationship between EksoNR robotic control settings and the biomechanics of walking; and 2) to uncover the psychological experiences during EksoNR use. To achieve these outcomes, the investigators are going to measure the effects of Swing Assist EksoNR settings on Gait kinematics; Kinetics; Muscle activity and Activation Timing; and User Experience.
The investigators will use a two-way repeated-measures design with a group (2 levels, healthy and stroke patients) as between factor and settings (4 levels) and user experience as within factors. It is an intra-subject design with an allocation ratio of 1/1. The healthy and stroke patients will have the same age limits.
Because there has not been a lot of research yet about the effect of different settings of the EksoNR on the rehabilitation of stroke patients or on the user experience using the EksoNR this study will use an exploratory framework. The purpose is to investigate what the different outcomes are for all the settings on biomechanical factors: muscle activity, kinematics and spatiotemporal factors.
The experiments will be conducted at the Brubotics Rehabilitation Research Center at the Vrije Universiteit Brussel (VUB)'s Brussels health campus (centrally located between Universitair Ziekenhuis Brussel (UZBrussel), Erasmushogeschool Brussel (EhB ) campus Jette and VUB Jette), led by Prof. Eva Swinnen and Prof. Nina Lefeber.
The participant needs to go to Brubotics Rehabilitation Research Center to perform two or three sessions in total with a break of 10 days (about 1 and a half weeks) in between.
Session 1 - Take in Session (1h) - At the beginning of this session the informed consent will be signed. Afterwards, the research team will prepare the settings and inquire about patient history, functional history, and physical evaluation. During the physical evaluation, it is necessary to do a gross assessment of strength, range of motion, and spasticity/tone; a detailed assessment of critical range of motion measurements; a qualitative assessment of pelvic posture and lumbar mobility; and check skin integrity. The patients walk with the EksoNR for at least 20 minutes.
Session 2 (1h) - This is a session to get familiar with walking with EksoNR for at least 20 minutes. It is only for stroke patients who have never walked with EksoNR, for that reason, if a patient has already used EksoNR before, will only do Session 1 + Session 3, skipping Session 2.
Session 3 (2h) - Each participant is going to walk 7 min (or min 25 gait cycles) in every condition, the order being randomly assigned and concealed from the patient (Trial 1- 4). For the random generation, each setting is going to be labelled and the sequence is going to be generated at the beginning of the session with a Matlab script. This script will randomly sort an array for each participant. Between trials, there is a rest of 5 min. During all walking trials, participants are allowed to stop and rest if necessary and research staff provided non-contact guarding for safety. In this session, kinetic data, spatio-temporal parameters, muscle activity and patient experience are going to be analyzed.
To make the analysis, the program Statistical Package for the Social Sciences (SPSS) version 27.0.1 will be used with a significance level set at 0,05. All data were summarized by using medians, standard deviations and means.
- Being tested
- High Swing Assistance, Neutral Swing Assistance, High Swing Resistance, Max Trajectory Control
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Swing AssistanceDevice
On this study, four settings are going to be evaluated being that High Swing Assistance, Neutral Swing Assistance, High Swing Resistance and Max Trajectory Control. The following settings will be used in all three conditions:
- Sitting program - "Min lean";
- Standing program - "Auto lean";
- Step initiation program - "ProStep+",
- Training mode - "Off",
- SmartAssist option - "2Free";
- Stance support - "Low". The level of stance support and swing assistance will be set symmetrically for the affected and non-affected side.
Each patient is going to walk 7 min (or min 25 gait cycles) with every setting
Neutral Swing AssistanceDevice
On this study, four settings are going to be evaluated being that High Swing Assistance, Neutral Swing Assistance, High Swing Resistance and Max Trajectory Control. The following settings will be used in all three conditions:
- Sitting program - "Min lean";
- Standing program - "Auto lean";
- Step initiation program - "ProStep+",
- Training mode - "Off",
- SmartAssist option - "2Free";
- Stance support - "Low". The level of stance support and swing assistance will be set symmetrically for the affected and non-affected side.
Each patient is going to walk 7 min (or min 25 gait cycles) with every setting
High Swing ResistanceDevice
On this study, four settings are going to be evaluated being that High Swing Assistance, Neutral Swing Assistance, High Swing Resistance and Max Trajectory Control. The following settings will be used in all three conditions:
- Sitting program - "Min lean";
- Standing program - "Auto lean";
- Step initiation program - "ProStep+",
- Training mode - "Off",
- SmartAssist option - "2Free";
- Stance support - "Low". The level of stance support and swing assistance will be set symmetrically for the affected and non-affected side.
Each patient is going to walk 7 min (or min 25 gait cycles) with every setting
Max Trajectory ControlDevice
On this study, four settings are going to be evaluated being that High Swing Assistance, Neutral Swing Assistance, High Swing Resistance and Max Trajectory Control. The following settings will be used in all three conditions:
- Sitting program - "Min lean";
- Standing program - "Auto lean";
- Step initiation program - "ProStep+",
- Training mode - "Off",
- SmartAssist option - "Bilateral";
- Stance support - "Low". The level of stance support and swing assistance will be set symmetrically for the affected and non-affected side.
Each patient is going to walk 7 min (or min 25 gait cycles) with every setting
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Experimental | Not described Receives: Device: High Swing Assistance; Device: Neutral Swing Assistance; Device: High Swing Resistance; Device: Max Trajectory Control |
| Healthy | Experimental | Not described Receives: Device: High Swing Assistance; Device: Neutral Swing Assistance; Device: High Swing Resistance; Device: Max Trajectory Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematics parameters
Measured using the Vicon Nexus. For kinematics, the angles of the lower extremities will be determined. Markers will be placed on the pelvis and the lower body both on the right and left side. The kinematics parameters will be measured while walking during the different conditions.
Measured: Data is only going to be collected on session 3 (day 3), between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway
Cadence
Measured using the Vicon Nexus. Markers will be placed on the pelvis and the lower body both on the right and left side. The cadence will be measured while walking during the different conditions.
Measured: Data is only going to be collected on session 3, between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway
Gait speed
Measured using the Vicon Nexus. Markers will be placed on the pelvis and the lower body both on the right and left side. Gait speed will be measured while walking during the different conditions.
Measured: Data is only going to be collected on session 3 (day 3), between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway
Step length
Measured using the Vicon Nexus. Markers will be placed on the pelvis and the lower body both on the right and left side. Step length will be measured while walking during the different conditions.
Measured: Data is only going to be collected on session 3 (day 3), between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway
Muscle Activity
The EMG Cometa will be used to evaluate muscle activity; therefore, the Electromyography (EMG) wireless sensors will be used. First the position of the anatomical landmarks must be located according to the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) guidelines for the following lower extremity muscles: Rectus Femoris (RF), Vastus Lateralis (VL), Vastus Medialis (VM), Biceps Femoris (BF), Tibialis Anterior (TA), Soleus (SOL), Gastrocnemius Lateralis (GL).
Measured: Data is only going to be collected on session 3 (day 3), between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway
Secondary outcomes (1)
User Experience
The secondary outcome is the acceptance and the experience of the users wearing and walking with the exoskeleton EksoNR. By the end of Session 3, each participant is going to fill an online survey created by the investigators, based on two existing questionnaires: Intrinsic Motivation Inventory (IMI) and Quebec User Evaluation of Satisfaction with assistive Technology 2.0 (QUEST 2.0). The questionnaire consists of six subscales: interest/enjoyment, perceived competence, effort/importance, pressure/tension, value/usefulness and relatedness. All different statements of the six subscales use a 5-point Likert scale, which means that participants give a score of one to five. With a score of one being "not at all true" and five being "very true". A higher score is associated with a higher internal motivation, excluding the pressure/ tension scale where a higher score is associated with a higher feeling of pressure .
Measured: Filled out by both the stroke and healthy patients immediately after the end of session 3 (day 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start25 Apr 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (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.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Responsible party
- Principal investigator, Eva Swinnen, Vrije Universiteit Brussel
- Investigators
- EVA SWINNEN, Prof. Ph.D, Study director, Vrije Universiteit BrusselChiara Cavallaro, Bachelor's, Principal investigator, Vrije Universiteit BrusselJoana Brites, Master's, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334030
- Sponsor's protocol ID
- EksoRehab
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking With the EksoNR in Stroke Patients and Healthy Controls: Biomechanical Changes and User Experience.
- ClinicalTrials.gov ID
- NCT05334030
- Acronym / sponsor ID
- EksoRehab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Study start
- 25 Apr 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 19 Apr 2022 (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.
Further studies are needed to provide more detailed information on the potential effects of robotic gait training in general, as well as on the influence on gait movement patterns in particular. Patient perspectives and feedback contribute to the continuous development of exoskeletal technology. For these reasons, the main objective of this study is to decipher the relationship between EksoNR's robotic control settings and walking biomechanics in stroke patients and healthy subjects; the second objective is to discover the user experience during the use of EksoNR.
Detailed description
Stroke is the leading cause of severe disability in adults resulting in mobility, balance, and coordination deficits. Because of this, walking recovery has a significant impact on stroke patients' quality of life. To improve rehabilitation techniques, robotic exoskeletons are being increasingly used during physiotherapy sessions. The use of robotic exoskeletons enhances conventional poststroke rehabilitation via intense and task-oriented training. To achieve a normal gait pattern, it is essential to restore the correct activation timing of the lower limb muscles.
Designed by Ekso Bionics, EksoNR is the first exoskeleton device to receive FDA clearance for rehabilitation use with patients with acquired brain injury and stroke patients. EksoNR has several settings that can be adapted to have the best user experience possible and to provide individual-specific training. This study is being proposed to better understand the impact of each setting on stroke recovery and user experience. The two key outcomes are 1) to decipher the relationship between EksoNR robotic control settings and the biomechanics of walking; and 2) to uncover the psychological experiences during EksoNR use. To achieve these outcomes, the investigators are going to measure the effects of Swing Assist EksoNR settings on Gait kinematics; Kinetics; Muscle activity and Activation Timing; and User Experience.
The investigators will use a two-way repeated-measures design with a group (2 levels, healthy and stroke patients) as between factor and settings (4 levels) and user experience as within factors. It is an intra-subject design with an allocation ratio of 1/1. The healthy and stroke patients will have the same age limits.
Because there has not been a lot of research yet about the effect of different settings of the EksoNR on the rehabilitation of stroke patients or on the user experience using the EksoNR this study will use an exploratory framework. The purpose is to investigate what the different outcomes are for all the settings on biomechanical factors: muscle activity, kinematics and spatiotemporal factors.
The experiments will be conducted at the Brubotics Rehabilitation Research Center at the Vrije Universiteit Brussel (VUB)'s Brussels health campus (centrally located between Universitair Ziekenhuis Brussel (UZBrussel), Erasmushogeschool Brussel (EhB ) campus Jette and VUB Jette), led by Prof. Eva Swinnen and Prof. Nina Lefeber.
The participant needs to go to Brubotics Rehabilitation Research Center to perform two or three sessions in total with a break of 10 days (about 1 and a half weeks) in between.
Session 1 - Take in Session (1h) - At the beginning of this session the informed consent will be signed. Afterwards, the research team will prepare the settings and inquire about patient history, functional history, and physical evaluation. During the physical evaluation, it is necessary to do a gross assessment of strength, range of motion, and spasticity/tone; a detailed assessment of critical range of motion measurements; a qualitative assessment of pelvic posture and lumbar mobility; and check skin integrity. The patients walk with the EksoNR for at least 20 minutes.
Session 2 (1h) - This is a session to get familiar with walking with EksoNR for at least 20 minutes. It is only for stroke patients who have never walked with EksoNR, for that reason, if a patient has already used EksoNR before, will only do Session 1 + Session 3, skipping Session 2.
Session 3 (2h) - Each participant is going to walk 7 min (or min 25 gait cycles) in every condition, the order being randomly assigned and concealed from the patient (Trial 1- 4). For the random generation, each setting is going to be labelled and the sequence is going to be generated at the beginning of the session with a Matlab script. This script will randomly sort an array for each participant. Between trials, there is a rest of 5 min. During all walking trials, participants are allowed to stop and rest if necessary and research staff provided non-contact guarding for safety. In this session, kinetic data, spatio-temporal parameters, muscle activity and patient experience are going to be analyzed.
To make the analysis, the program Statistical Package for the Social Sciences (SPSS) version 27.0.1 will be used with a significance level set at 0,05. All data were summarized by using medians, standard deviations and means.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke | Experimental | Device: High Swing Assistance, Device: Neutral Swing Assistance, Device: High Swing Resistance, Device: Max Trajectory Control |
| Healthy | Experimental | Device: High Swing Assistance, Device: Neutral Swing Assistance, Device: High Swing Resistance, Device: Max Trajectory Control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- People diagnosed with first-ever stroke (as defined by the WHO);
- Age between 18 and 80 years;
- Time since diagnosis between 1 week and 6 months;
- Functional ambulation category below 3 (meaning a patient who requires intermittent or continuous manual contact to support body weight, maintain balance or assist coordination.);
- Does not meet the Ekso robotic exoskeleton frame limitations (See list below)
Key exclusion criteria (33 listed)
- Extensive experience with the use of the EksoNR (more than four training sessions);
- Other neurological or musculoskeletal problems leading to impaired gait (unrelated to their stroke);
- Severe complicating comorbidities (e.g., cardiovascular instability, pulmonary diseases);
- Severe deficits of communication, memory or understanding (25 points or less on the MoCA test);
- And contraindications for EksoNR use (see list below).
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 |
|---|---|---|
| High Swing AssistanceOn this study, four settings are going to be evaluated being that High Swing Assistance, Neutral Swing Assistance, High Swing Resistance and Max Trajectory Control. The following settings will be used in all three conditions: * Sitting program - "Min lean"; * Standing program - "Auto lean"; * Step initiation program - "ProStep+", * Training mode - "Off", * SmartAssist option - "2Free"; * Stance support - "Low". The level of stance support and swing assistance will be set symmetrically for the affected and non-affected side. Each patient is going to walk 7 min (or min 25 gait cycles) with every setting | Device | Healthy, Stroke |
| Neutral Swing AssistanceOn this study, four settings are going to be evaluated being that High Swing Assistance, Neutral Swing Assistance, High Swing Resistance and Max Trajectory Control. The following settings will be used in all three conditions: * Sitting program - "Min lean"; * Standing program - "Auto lean"; * Step initiation program - "ProStep+", * Training mode - "Off", * SmartAssist option - "2Free"; * Stance support - "Low". The level of stance support and swing assistance will be set symmetrically for the affected and non-affected side. Each patient is going to walk 7 min (or min 25 gait cycles) with every setting | Device | Healthy, Stroke |
| High Swing ResistanceOn this study, four settings are going to be evaluated being that High Swing Assistance, Neutral Swing Assistance, High Swing Resistance and Max Trajectory Control. The following settings will be used in all three conditions: * Sitting program - "Min lean"; * Standing program - "Auto lean"; * Step initiation program - "ProStep+", * Training mode - "Off", * SmartAssist option - "2Free"; * Stance support - "Low". The level of stance support and swing assistance will be set symmetrically for the affected and non-affected side. Each patient is going to walk 7 min (or min 25 gait cycles) with every setting | Device | Healthy, Stroke |
| Max Trajectory ControlOn this study, four settings are going to be evaluated being that High Swing Assistance, Neutral Swing Assistance, High Swing Resistance and Max Trajectory Control. The following settings will be used in all three conditions: * Sitting program - "Min lean"; * Standing program - "Auto lean"; * Step initiation program - "ProStep+", * Training mode - "Off", * SmartAssist option - "Bilateral"; * Stance support - "Low". The level of stance support and swing assistance will be set symmetrically for the affected and non-affected side. Each patient is going to walk 7 min (or min 25 gait cycles) with every setting | Device | Healthy, Stroke |
Primary outcome
Kinematics parameters
Time frame: Data is only going to be collected on session 3 (day 3), between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway
Measured using the Vicon Nexus. For kinematics, the angles of the lower extremities will be determined. Markers will be placed on the pelvis and the lower body both on the right and left side. The kinematics parameters will be measured while walking during the different conditions.
Cadence
Time frame: Data is only going to be collected on session 3, between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway
Measured using the Vicon Nexus. Markers will be placed on the pelvis and the lower body both on the right and left side. The cadence will be measured while walking during the different conditions.
Gait speed
Time frame: Data is only going to be collected on session 3 (day 3), between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway
Measured using the Vicon Nexus. Markers will be placed on the pelvis and the lower body both on the right and left side. Gait speed will be measured while walking during the different conditions.
Step length
Time frame: Data is only going to be collected on session 3 (day 3), between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway
Measured using the Vicon Nexus. Markers will be placed on the pelvis and the lower body both on the right and left side. Step length will be measured while walking during the different conditions.
Muscle Activity
Time frame: Data is only going to be collected on session 3 (day 3), between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway
The EMG Cometa will be used to evaluate muscle activity; therefore, the Electromyography (EMG) wireless sensors will be used. First the position of the anatomical landmarks must be located according to the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) guidelines for the following lower extremity muscles: Rectus Femoris (RF), Vastus Lateralis (VL), Vastus Medialis (VM), Biceps Femoris (BF), Tibialis Anterior (TA), Soleus (SOL), Gastrocnemius Lateralis (GL).
1 secondary outcome
User Experience
Time frame: Filled out by both the stroke and healthy patients immediately after the end of session 3 (day 3).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
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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.
EVA SWINNEN, Prof. Ph.D study director
Vrije Universiteit Brussel
Chiara Cavallaro, Bachelor's principal investigator
Vrije Universiteit Brussel
Joana Brites, Master's principal investigator
Vrije Universiteit Brussel
Questions about this trial
What is this clinical trial studying?
A study testing High Swing Assistance, Neutral Swing Assistance and High Swing Resistance in people with Stroke and Healthy, run by Vrije Universiteit Brussel.
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 33 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 19 Apr 2022. 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 Eva SWINNEN, Prof. Ph.D (003224774527, eva.swinnen@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematics parameters (time frame: Data is only going to be collected on session 3 (day 3), between minutes 2 and 6 of recording for each setting. This time frame is used to avoid the effects of the acceleration and deceleration phases at the beginning and at the end of the walk pathway). 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 19 Apr 2022.