Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).

NCT07867847 | Not Yet Recruiting

• 1 other identifier: Ver. 4.4 date 06/08/2026
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Hemiplegia; Hemiparesis

Keywords

Stroke; Hemiplegia; Hemiparesis

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 20 sessions that corresponds up to 8 weeks

Study Arms (1)

Robotic orthesis

EXPERIMENTAL

This arm permits to assess the usability of the device (bionic system) from the patient point of view

Device: Bionic System (AWAKE)

Interventions

Bionic System (AWAKE) DEVICE

Intervention involving the use of this bionic system to perform walking functions

Robotic orthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Bionic Mobility Solutions, S.L.: lead

MeSH Terms

Conditions

Hemiplegia; Paresis; Stroke

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Julian Mateus

  Hospital d'Atenció Intermèdia Colisée Barcelona Isabel Roig

  PRINCIPAL INVESTIGATOR

• Gabriel Fernando Sandoval

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Comité de Ética de la Incestigació Germans Trias i Pujol

CONTACT

+34 93 497 8956; ceic.germanstrias@gencat.cat

Robopedics

CONTACT

+34 659440164; ivan@robopedics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: October 9, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share