HemiplegiaVAWAKENCT07867847
Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
A study testing Bionic System (AWAKE) in people with Hemiplegia and Hemiparesis, run by Bionic Mobility Solutions, S.L..
Trial summary
Stroke is a leading cause of disability in adults, with gait impairment being a key functional limitation. Although lower limb exoskeletons are used in rehabilitation, the available evidence focuses on bilateral devices used in clinical settings with continuous supervision by healthcare professionals, and is limited… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiplegia, Hemiparesis
- What is being tested?
- Bionic System (AWAKE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, over 18 years old, diagnosed with hemiplegia or hemiparesis secondary to stroke.
- Subacute or chronic phase of stroke.
- Height between 155 and 185 cm. Weight between 50 and 100 kg.
- Spasticity <=3 according to the Modified Ashworth Scale (MAS) in the lower extremity affected.
- Range of motion in the joints between 0º and 110º of flexion in the knee and 120º of flexion and 20º of extension in the hip.
- To have a minimum functional level that permit the safe use of the device, including sufficient strength on the unaffected side, trunk control, and the ability to perform basic transfers with assistance. This requirement is met if the patient can maintain a supported standing position for at least 30 seconds and safely perform bed-to-chair and chair-to-standing transfers with assistance/supervision
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Comité de Ética de la Incestigació Germans Trias i Pujol contact
About this study
Stroke is a leading cause of disability in adults, with gait impairment being a key functional limitation. Although lower limb exoskeletons are used in rehabilitation, the available evidence focuses on bilateral devices used in clinical settings with continuous supervision by healthcare professionals, and is limited for solutions with alternative configurations and usage conditions.
The AWAKE device is designed as a compensatory solution for gait impairment following stroke. It features a unilateral configuration, low weight, and a design intended for use with a companion (not necessarily a medical professional) in broader settings. The purpose of this study is to demonstrate that the AWAKE device is safe and functions properly for its intended use in patients with hemiplegia or hemiparesis secondary to a stroke, together with a companion, provided that both have successfully completed the planned training and education program.
Read more
This is a prospective, multicenter, single-arm, open-label, interventional clinical study designed to evaluate the safety and performance of the AWAKE device in patients with hemiplegia or hemiparesis secondary to stroke, along with their usual companion.
The total number of patients will be:
Twenty pairs (patient + regular companion) will be recruited and equally divided between two participating centers.
Each pair will undergo 10 to 20 sessions, two or three times per week, under the supervision of healthcare professionals previously trained by the manufacturer.
Read the detailed description
The main objective of this study is to demonstrate that the AWAKE device is safe and functions properly for its intended use and for the users for whom it is designed; that is, so that patients with hemiplegia or hemiparesis secondary to a stroke (ACV) can safely perform walking functions together with a companion, provided that both have successfully completed the planned training program.
The secondary objectives are:
To evaluate the usability of the AWAKE device for the patient and, To evaluate the usability of AWAKE device for the regular caregiver of the patient.
Additionally, it will be assessed the following exploratory objectives:
Evaluate the degree of dependence, functional status, gait quality, and quality of life of the patients at the beginning and end of the study. Evaluate the patients' perception of the usefulness of the AWAKE device.
- Conditions
- Hemiplegia, Hemiparesis
- Being tested
- Bionic System (AWAKE)
- Keywords
- Stroke, Hemiplegia, Hemiparesis
- Medical subject headings
- Hemiplegia, Paresis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bionic System (AWAKE)Device
Intervention involving the use of this bionic system to perform walking functions
| Study group | Role | What they receive |
|---|---|---|
| Robotic orthesis | Experimental | This arm permits to assess the usability of the device (bionic system) from the patient point of view Receives: Device: Bionic System (AWAKE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients able to perform walking functions
To confirm the design and operating specifications of the bionic system permit that patient performs the walking function.
Measured: Up to 20 sessions that corresponds up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start21 Sep 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bionic Mobility Solutions, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julian Mateus, Principal investigator, Hospital d'Atenció Intermèdia Colisée Barcelona Isabel RoigGabriel Fernando Sandoval, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867847
- Sponsor's protocol ID
- Ver. 4.4 date 06/08/2026
- Acronym
- VAWAKE
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the novelty of this device and that there is no equivalent device placed into the worldwide market yet, the IPD will not be shared to protect it against competitors
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
- ClinicalTrials.gov ID
- NCT07867847
- Acronym / sponsor ID
- VAWAKE / Ver. 4.4 date 06/08/2026
- Conditions
- Hemiplegia, Hemiparesis
- Keywords
- Stroke, Hemiplegia, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bionic Mobility Solutions, S.L.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Oct 2026 (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.
Stroke is a leading cause of disability in adults, with gait impairment being a key functional limitation. Although lower limb exoskeletons are used in rehabilitation, the available evidence focuses on bilateral devices used in clinical settings with continuous supervision by healthcare professionals, and is limited for solutions with alternative configurations and usage conditions.
The AWAKE device is designed as a compensatory solution for gait impairment following stroke. It features a unilateral configuration, low weight, and a design intended for use with a companion (not necessarily a medical professional) in broader settings. The purpose of this study is to demonstrate that the AWAKE device is safe and functions properly for its intended use in patients with hemiplegia or hemiparesis secondary to a stroke, together with a companion, provided that both have successfully completed the planned training and education program.
This is a prospective, multicenter, single-arm, open-label, interventional clinical study designed to evaluate the safety and performance of the AWAKE device in patients with hemiplegia or hemiparesis secondary to stroke, along with their usual companion.
The total number of patients will be:
Twenty pairs (patient + regular companion) will be recruited and equally divided between two participating centers.
Each pair will undergo 10 to 20 sessions, two or three times per week, under the supervision of healthcare professionals previously trained by the manufacturer.
Detailed description
The main objective of this study is to demonstrate that the AWAKE device is safe and functions properly for its intended use and for the users for whom it is designed; that is, so that patients with hemiplegia or hemiparesis secondary to a stroke (ACV) can safely perform walking functions together with a companion, provided that both have successfully completed the planned training program.
The secondary objectives are:
To evaluate the usability of the AWAKE device for the patient and, To evaluate the usability of AWAKE device for the regular caregiver of the patient.
Additionally, it will be assessed the following exploratory objectives:
Evaluate the degree of dependence, functional status, gait quality, and quality of life of the patients at the beginning and end of the study. Evaluate the patients' perception of the usefulness of the AWAKE device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic orthesis | Experimental | Device: Bionic System (AWAKE)This arm permits to assess the usability of the device (bionic system) from the patient point of view |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult, over 18 years old, diagnosed with hemiplegia or hemiparesis secondary to stroke.
- Subacute or chronic phase of stroke.
- Height between 155 and 185 cm. Weight between 50 and 100 kg.
- Spasticity <=3 according to the Modified Ashworth Scale (MAS) in the lower extremity affected.
- Range of motion in the joints between 0º and 110º of flexion in the knee and 120º of flexion and 20º of extension in the hip.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Bionic System (AWAKE)Intervention involving the use of this bionic system to perform walking functions | Device | Robotic orthesis |
Primary outcome
Number of patients able to perform walking functions
Time frame: Up to 20 sessions that corresponds up to 8 weeks
To confirm the design and operating specifications of the bionic system permit that patient performs the walking function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No. Due to the novelty of this device and that there is no equivalent device placed into the worldwide market yet, the IPD will not be shared to protect it against competitors
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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.
Comité de Ética de la Incestigació Germans Trias i Pujol contact
Julian Mateus principal investigator
Hospital d'Atenció Intermèdia Colisée Barcelona Isabel Roig
Gabriel Fernando Sandoval principal investigator
Germans Trias i Pujol Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Bionic System (AWAKE) in people with Hemiplegia and Hemiparesis, run by Bionic Mobility Solutions, S.L..
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 0 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: opening soon, as of the sponsor's last update on 9 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Comité de Ética de la Incestigació Germans Trias i Pujol (+34 93 497 8956, ceic.germanstrias@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients able to perform walking functions (time frame: Up to 20 sessions that corresponds up to 8 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 9 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.