NCT07867847Not yet recruiting
Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 22 Sept 2026
- Start date
- 21 Sept 2026
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Bionic Mobility Solutions, S.L.
- Diseases
- Stroke
- NCT number
- NCT07867847
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 21 Sept 2026 to the primary completion date, 30 Nov 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.