Evaluation of the Use of the Atalante Exoskeleton in Patients Presenting an Hemiplegia Due to Cerebrovascular Accident

NCT04694001 | Completed DMC

• 1 other identifier: INSPIRE
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 6

Brief Summary

The INSPIRE study is interventional, European, prospective, open, multicentric, each patient being his/her own control. It is conducted to assess the safety and performance of the Atalante exoskeleton system in patients presenting an hemiplegia due to cerebrovascular accident. The primary endpoint is defined by the reported adverse events. The study will include 40 patients and takes place in six rehabilitation centers (4 in France, 1 in Luxembourg, 1 in Belgium).

Conditions

Stroke; Stroke, Acute; Stroke, Subacute; Chronic Stroke

Keywords

Robotics; Rehabilitation; Physiotherapy; Powered exoskeleton; Walking; Exercises; Ambulation; Stroke; Acute stroke; Subacute stroke; Chronic stroke

Outcome Measures

Primary Outcomes (1)

• The primary objective is to evaluate the incidence of treatment-emergent adverse events.

  The primary endpoint is measured through reported Adverse Events (AEs) including adverse events (AEs), adverse device effects (ADEs), serious adverse events (SAEs), serious adverse device effects (SADEs), adverse procedure effects (APE), and new findings (NFs).

  Throughout study completion, an average of 6 days

Secondary Outcomes (11)

• Evaluate the patient's ability to walk without the Atalante exoskeleton

  At study start, day 1 and at study completion, up to 6 days

• Evaluate the patient's gait speed without the Atalante exoskeleton

  At study start, day 1 and at study completion, up to 6 days

• Evaluate the patient's endurance without the Atalante exoskeleton

  At study start, day 1 and at study completion, up to 6 days

• Evaluate the patient's static and dynamic balance without the Atalante exoskeleton

  At study start, day 1 and at study completion, up to 6 days

• Evaluate the patient's spasticity

  At study start, day 1 and at study completion, up to 6 days

Study Arms (1)

Hemiplegia due to Cerebrovascular Accident (CVA)

OTHER

Device: Use of the Atalante exoskeleton

Interventions

Use of the Atalante exoskeleton DEVICE

A session includes stand-up, walks, exercises with or without the assistance of the exoskeleton, rotation, side and back step, squat and sitting.

Hemiplegia due to Cerebrovascular Accident (CVA)

Eligibility Criteria

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

You may qualify if:

• Patient with hemiplegia due to cerebrovascular accident, occurred two weeks ago or more, follow up in a rehabilitation center or in a hospital (inpatient or outpatient),
• Patient presenting a FAC score of 0, 1, 2 or 3,
• Patient whose etiological evaluation of the stroke has been complete,
• Adult patient ≥18 years old,
• Patient able to read and write in at least one of the languages of the country and who have signed an informed consent form.

You may not qualify if:

• Individuals with severe spasticity of adductor muscles, hamstring, quadriceps and triceps surae. Severe spasticity is defined by a score greater than 3 on the modified Ashworth scale,
• Pregnant women
• Individuals with history of osteoporotic fracture and pathology or treatment causing secondary osteoporosis,
• Pressure Ulcer of Grade I or higher according to the National Pressure Ulcer Advisory Panel (NPUAP) International Pressure Ulcer Classification System- European Pressure Ulcer Advisory Panel (EPUAP), in areas of contact with the Atalante system,
• Severe aphasia limiting ability to express needs or to fulfil questionnaires, at the discretion of the physician.
• Patient with a cardiac or respiratory contraindication to physical exertion,
• Patient with a score below 18 on the Mini Mental State test,
• Patient unable to deliver his/her consent,
• Patient under legal protection,
• Patient participating at the same time in another study,
• Patients with morphological contraindications to the use of the Atalante exoskeleton.

Sponsors & Collaborators

• Wandercraft: lead

Study Sites (6)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Centre Jacques Calvé - Fondation Hopale

Berck, 62600, France

Location

Centre de Médecine Physique et de Réadaptation

Pionsat, 63330, France

Location

Centre mutualiste de Rééducation et de Réadaptation de Kerpape

Ploemeur, 56270, France

Location

Hôpital La Musse, La Renaissance Sanitaire

Saint-Sébastien-de-Morsent, 20119, France

Location

Rehazenter

Luxembourg, 2674, Luxembourg

Location

Related Publications (1)

• Lejeune T, Nuic D, Dehem S, Previnaire JG, Cuenot C, Debugne T, Kaps J, Paul B, Pean V, Perez SS, Juhel F, Tatsidou S, Kerdraon J. Hands-free Atalante exoskeleton in post-stroke gait and balance rehabilitation: a safety study. J Neuroeng Rehabil. 2025 Apr 12;22(1):82. doi: 10.1186/s12984-025-01621-z.

  PMID: 40221748 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Design

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

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 5, 2021
• Study Start: April 12, 2021
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

BE (1); FR (4); LU (1)