StrokeNCT04228224
Stroke Rehabilitation Program Based on a Powered Lower Extremity Exoskeleton in Chile
A study testing Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain) and Conventional gait rehabilitation in people with Stroke, run by Corporación de Rehabilitación Club de Leones Cruz del Sur at 1 site in Chile.
Trial summary
This research will study the effects of a rehabilitation program assisted by a powered lower extremity exoskeleton in patients after stroke. It will compare clinical and biomechanical features of patients at baseline and after intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain) and Conventional gait rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- 1 Jul 2019to 31 Mar 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- unilateral lower extremity paresis
- haemorrhagic or ischemic stroke
- a minimum of six months after the acute infarction/onset of the disease
- full passive range of motion in lower extremity or at least at neutral position
- be able to stand freely
- be able to walk with or without aid for at least 20 meters in less than 2 minutes
Who cannot join
- peripheral nervous system pathology
- epilepsy
- weight over 100 kg
- no cognitive ability to follow the study instructions
- pregnancy
- use of implanted devices
- instable lower extremity joints or fixed contracture
Trial locations and contacts
1 site in 1 country.
Chile1 site
Corporación de Rehabilitación Club de Leones Cruz del Sur
Punta Arenas, Region of Magallanes, 6211525
About this study
This research will study the effects of a rehabilitation program assisted by a powered lower extremity exoskeleton in patients after stroke. It will compare clinical and biomechanical features of patients at baseline and after intervention. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.
Read the detailed description
Stroke is one of the leading causes of mortality, morbidity and disability in adults in developed countries. Survivors may suffer several neurological deficits or deficiencies, such as hemiparesis, communication disorders, cognitive deficits and visuospatial perception disorders. Hemiplegia is a par loss of hemi-body voluntary motricity following a brain injury, usually resulting in alterations of the locomotor system with persistent disorders of movement and posture. Hemiplegia significantly affects gait performance. Gait recovery is an important objective in the rehabilitation program for stroke patients.The currently available treatment techniques include classical techniques of gait rehabilitation, functional electrical stimulation, electromechanic devices, robotic devices and brain-computer interfaces, among others.The evidence suggest that the combination of different rehabilitation strategies is more effective than conventional rehabilitation techniques alone. Technology-based rehabilitation methods such as robotic devices need more research to demonstrate their effects on gait recovery.
This study will assess the effects of a rehabilitation program with a powered lower extremity exoskeleton in people with stroke. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.
- Conditions
- Stroke
- Being tested
- Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain), Conventional gait rehabilitation
- Keywords
- Stroke, Hemiparesis, Gait, Brain-Computer Interface, Rehabilitation, Exoskeleton
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain)Device
The H3 is a powered lower extremity exoskeleton with actuated at hips, knees and ankles joints. A novel control software has been design and implemented in this device, which allows selective joint movement and recording of data from each rehabilitation session.
Conventional gait rehabilitationBehavioural
Conventional gait rehabilitation consist in walking and other applicable lower limb exercises performed by participants with assistance of a physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted Rehabilitation | Experimental | Participants will receive Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain). Patients will perform lower limb exercises assisted by the device. Training involve 24 sessions, 2 sessions per week for 12 weeks, each lasting about 1 hour. Receives: Device: Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain) |
| Conventional Gait Rehabilitation | Active comparator | Participants in this group will perform conventional gait rehabilitation on a rehabilitation institution with assistance of a physical therapist. Training involve 24 sessions, 2 sessions per week, each session lasting about 1 hour. Receives: Behavioral: Conventional gait rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Deviation Index Baseline
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Measured: Baseline
Gait Deviation Index Post-Intervention
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Measured: 12 weeks
Secondary outcomes (21)
Maximal muscle strength Baseline
Maximal muscle strength (peak torque, Nm) during maximal voluntary unilateral hip extension-flexion, and hip adduction-abduction (standing), knee extension-flexion (seated), respectively. Both the affected (AF) and non-affected (NA) leg. A hand-held dynamometer will be used for the assessment.
Measured: Baseline
Maximal muscle strength Post-Intervention
Maximal muscle strength (peak torque, Nm) during maximal voluntary unilateral hip extension-flexion, and hip adduction-abduction (standing), knee extension-flexion (seated), respectively. Both the affected (AF) and non-affected (NA) leg. A hand-held dynamometer will be used for the assessment.
Measured: 12 weeks
Distance in 6 Minute Walk Test (6MWT) Baseline
Measure of the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test consist in a evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance.
Measured: Baseline
Distance in 6 Minute Walk Test (6MWT) Post-Intervention
Measure of the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test consist in a evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance.
Measured: 12 weeks
Muscle tone measured using modified ashworth scale (MAS) Baseline
Tests resistance to passive movement about a joint with varying degrees of velocity. A score of 1 indicates no resistance, and 5 indicates rigidity.
Measured: Baseline
Muscle tone measured using modified ashworth scale (MAS) Post-Intervention
Tests resistance to passive movement about a joint with varying degrees of velocity. A score of 1 indicates no resistance, and 5 indicates rigidity.
Measured: 12 weeks
Passive range of motion Baseline
Passive range of motion in lower extremities. ROM will be assessed by using an universal goniometer
Measured: Baseline
Passive range of motion Post-Intervention
Passive range of motion in lower extremities. ROM will be assessed by using an universal goniometer
Measured: 12 weeks
10 meter walk test Baseline
The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
Measured: Baseline
10 meter walk test Post-Intervention
The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
Measured: 12 weeks
Timed Up and Go Baseline
Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. The person wears regular footwear and customary walking aid.
Measured: Baseline
Timed Up and Go Post-Intervention
Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. The person wears regular footwear and customary walking aid.
Measured: 12 weeks
Berg Balance Scale Baseline
Berg balance scale is used for functional balance. participants are asked to perform 14 tasks frequently used in daily life activities. The highest possible score is 56 points. A higher score indicates better balance.
Measured: Baseline
Berg Balance Scale Post-Intervention
Berg balance scale is used for functional balance. participants are asked to perform 14 tasks frequently used in daily life activities. The highest possible score is 56 points. A higher score indicates better balance.
Measured: 12 weeks
Functional Ambulation Classification (FAC) Baseline
FAC is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.
Measured: Baseline
Functional Ambulation Classification (FAC) Post-Intervention
FAC is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.
Measured: 12 weeks
Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
Measured with QUEST scale. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components, Device and Services. Scores of 1 indicate dissatisfaction and scores of 5 indicate high satisfaction
Measured: 12 weeks
Medical Research Council test (MRC) Baseline
Manual evaluation of muscle strength. This scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. Grade 0 = no movement is observed, grade 5= muscle contracts normally against full resistance. Six muscles groups are tested at both sides of the body: shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, ankle dorsiflexion. Maximal total score is 60.
Measured: Baseline
Medical Research Council test (MRC) Post-Intervention
Manual evaluation of muscle strength. This scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. Grade 0 = no movement is observed, grade 5= muscle contracts normally against full resistance. Six muscles groups are tested at both sides of the body: shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, ankle dorsiflexion. Maximal total score is 60.
Measured: 12 weeks
Gait Speed Baseline
Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
Measured: Baseline
Gait Speed Post-intervention
Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Jul 2019
- Primary completion31 Jan 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporación de Rehabilitación Club de Leones Cruz del Sur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asterio H Andrade Gallardo, MSc., Study chair, Corporación de Rehabilitacion Club de Leones Cruz del Sur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228224
- Sponsor's protocol ID
- CorporacionRCLCS0001
- Status last verified
- Jul 2020
- First submitted
- 8 Jan 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flansbjer UB, Holmback AM, Downham D, Patten C, Lexell J. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005 Mar;37(2):75-82. doi: 10.1080/16501970410017215.
PubMed 15788341Belda-Lois JM, Mena-del Horno S, Bermejo-Bosch I, Moreno JC, Pons JL, Farina D, Iosa M, Molinari M, Tamburella F, Ramos A, Caria A, Solis-Escalante T, Brunner C, Rea M. Rehabilitation of gait after stroke: a review towards a top-down approach. J Neuroeng Rehabil. 2011 Dec 13;8:66. doi: 10.1186/1743-0003-8-66.
PubMed 22165907Bortole M, Venkatakrishnan A, Zhu F, Moreno JC, Francisco GE, Pons JL, Contreras-Vidal JL. The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study. J Neuroeng Rehabil. 2015 Jun 17;12:54. doi: 10.1186/s12984-015-0048-y.
PubMed 26076696Wallard L, Dietrich G, Kerlirzin Y, Bredin J. Effects of robotic gait rehabilitation on biomechanical parameters in the chronic hemiplegic patients. Neurophysiol Clin. 2015 Sep;45(3):215-9. doi: 10.1016/j.neucli.2015.03.002. Epub 2015 Sep 14.
PubMed 26381192
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Rehabilitation Program Based on a Powered Lower Extremity Exoskeleton in Chile
- ClinicalTrials.gov ID
- NCT04228224
- Acronym / sponsor ID
- CorporacionRCLCS0001
- Conditions
- Stroke
- Keywords
- Stroke, Hemiparesis, Gait, Brain-Computer Interface, Rehabilitation, Exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Corporación de Rehabilitación Club de Leones Cruz del SurUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will study the effects of a rehabilitation program assisted by a powered lower extremity exoskeleton in patients after stroke. It will compare clinical and biomechanical features of patients at baseline and after intervention. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.
Detailed description
Stroke is one of the leading causes of mortality, morbidity and disability in adults in developed countries. Survivors may suffer several neurological deficits or deficiencies, such as hemiparesis, communication disorders, cognitive deficits and visuospatial perception disorders. Hemiplegia is a par loss of hemi-body voluntary motricity following a brain injury, usually resulting in alterations of the locomotor system with persistent disorders of movement and posture. Hemiplegia significantly affects gait performance. Gait recovery is an important objective in the rehabilitation program for stroke patients.The currently available treatment techniques include classical techniques of gait rehabilitation, functional electrical stimulation, electromechanic devices, robotic devices and brain-computer interfaces, among others.The evidence suggest that the combination of different rehabilitation strategies is more effective than conventional rehabilitation techniques alone. Technology-based rehabilitation methods such as robotic devices need more research to demonstrate their effects on gait recovery.
This study will assess the effects of a rehabilitation program with a powered lower extremity exoskeleton in people with stroke. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted Rehabilitation | Experimental | Device: Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain)Participants will receive Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain). Patients will perform lower limb exercises assisted by the device. Training involve 24 sessions, 2 sessions per week for 12 weeks, each lasting about 1 hour. |
| Conventional Gait Rehabilitation | Active comparator | Behavioral: Conventional gait rehabilitationParticipants in this group will perform conventional gait rehabilitation on a rehabilitation institution with assistance of a physical therapist. Training involve 24 sessions, 2 sessions per week, each session lasting about 1 hour. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- unilateral lower extremity paresis
- haemorrhagic or ischemic stroke
- a minimum of six months after the acute infarction/onset of the disease
- full passive range of motion in lower extremity or at least at neutral position
- be able to stand freely
Key exclusion criteria (7 listed)
- peripheral nervous system pathology
- epilepsy
- weight over 100 kg
- no cognitive ability to follow the study instructions
- pregnancy
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 |
|---|---|---|
| Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain)The H3 is a powered lower extremity exoskeleton with actuated at hips, knees and ankles joints. A novel control software has been design and implemented in this device, which allows selective joint movement and recording of data from each rehabilitation session. | Device | Robot-assisted Rehabilitation |
| Conventional gait rehabilitationConventional gait rehabilitation consist in walking and other applicable lower limb exercises performed by participants with assistance of a physical therapist. | Behavioural | Conventional Gait Rehabilitation |
Primary outcome
Gait Deviation Index Baseline
Time frame: Baseline
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Gait Deviation Index Post-Intervention
Time frame: 12 weeks
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
21 secondary outcomes
Maximal muscle strength Baseline
Time frame: Baseline
Maximal muscle strength Post-Intervention
Time frame: 12 weeks
Distance in 6 Minute Walk Test (6MWT) Baseline
Time frame: Baseline
Distance in 6 Minute Walk Test (6MWT) Post-Intervention
Time frame: 12 weeks
Muscle tone measured using modified ashworth scale (MAS) Baseline
Time frame: Baseline
Muscle tone measured using modified ashworth scale (MAS) Post-Intervention
Time frame: 12 weeks
Passive range of motion Baseline
Time frame: Baseline
Passive range of motion Post-Intervention
Time frame: 12 weeks
10 meter walk test Baseline
Time frame: Baseline
10 meter walk test Post-Intervention
Time frame: 12 weeks
Timed Up and Go Baseline
Time frame: Baseline
Timed Up and Go Post-Intervention
Time frame: 12 weeks
Berg Balance Scale Baseline
Time frame: Baseline
Berg Balance Scale Post-Intervention
Time frame: 12 weeks
Functional Ambulation Classification (FAC) Baseline
Time frame: Baseline
Functional Ambulation Classification (FAC) Post-Intervention
Time frame: 12 weeks
Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
Time frame: 12 weeks
Medical Research Council test (MRC) Baseline
Time frame: Baseline
Medical Research Council test (MRC) Post-Intervention
Time frame: 12 weeks
Gait Speed Baseline
Time frame: Baseline
Gait Speed Post-intervention
Time frame: 12 weeks
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 16 Jul 2020.
- Background: PubMed 15788341Flansbjer UB, Holmback AM, Downham D, Patten C, Lexell J. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005 Mar;37(2):75-82. doi: 10.1080/16501970410017215.
- Background: PubMed 22165907Belda-Lois JM, Mena-del Horno S, Bermejo-Bosch I, Moreno JC, Pons JL, Farina D, Iosa M, Molinari M, Tamburella F, Ramos A, Caria A, Solis-Escalante T, Brunner C, Rea M. Rehabilitation of gait after stroke: a review towards a top-down approach. J Neuroeng Rehabil. 2011 Dec 13;8:66. doi: 10.1186/1743-0003-8-66.
- Background: PubMed 26076696Bortole M, Venkatakrishnan A, Zhu F, Moreno JC, Francisco GE, Pons JL, Contreras-Vidal JL. The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study. J Neuroeng Rehabil. 2015 Jun 17;12:54. doi: 10.1186/s12984-015-0048-y.
- Background: PubMed 26381192Wallard L, Dietrich G, Kerlirzin Y, Bredin J. Effects of robotic gait rehabilitation on biomechanical parameters in the chronic hemiplegic patients. Neurophysiol Clin. 2015 Sep;45(3):215-9. doi: 10.1016/j.neucli.2015.03.002. Epub 2015 Sep 14.
- Individual participant dataSharing planned: No
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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.
Asterio H Andrade Gallardo, MSc. study chair
Corporación de Rehabilitacion Club de Leones Cruz del Sur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain) and Conventional gait rehabilitation in people with Stroke, run by Corporación de Rehabilitación Club de Leones Cruz del Sur at 1 site in Chile.
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 7 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 16 Jul 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 Chile. 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?
Gait Deviation Index Baseline (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04228224, which also lists 4 linked publications.
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 16 Jul 2020; AzTrials last refreshed its copy on 29 Oct 2026.