An interventional study of Bionic System (AWAKE) in Hemiplegia and Hemiparesis, sponsored by Bionic Mobility Solutions, S.L.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Bionic Mobility Solutions, S.L. · Not applicable, Interventional, and Device feasibility
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.
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.
390 studies on the registry are indexed under Hemiplegia; 87 are open to participants now.
This study's planned enrollment of 20 is below the median of 36 across 322 interventional studies indexed under Hemiplegia.
Browse Hemiplegia studies →This is the only study on the registry with Bionic Mobility Solutions, S.L. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
This arm permits to assess the usability of the device (bionic system) from the patient point of view
Device: Bionic System (AWAKE)
Intervention involving the use of this bionic system to perform walking functions
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.
Time frame: Up to 20 sessions that corresponds up to 8 weeks
No study locations are listed for this record.
Plan to share: 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
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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