Evaluation of the Use of the Atalante Exoskeleton in Patients Presenting an Hemiplegia Due to Cerebrovascular Accident - Clinical Trial for Stroke | NCT04694001

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Use of the Atalante exoskeleton

About this trial

This is an interventional other trial for Stroke focused on measuring Robotics, Rehabilitation, Physiotherapy, Powered exoskeleton, Walking, Exercises, Ambulation, Stroke, Acute stroke, Subacute stroke, Chronic stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Cliniques universitaires Saint-Luc
Centre Jacques Calvé - Fondation Hopale
Centre de Médecine Physique et de Réadaptation
Centre mutualiste de Rééducation et de Réadaptation de Kerpape
Hôpital La Musse, La Renaissance Sanitaire
Rehazenter

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hemiplegia due to Cerebrovascular Accident (CVA)

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Evaluation of the walk performance with the Functional Ambulation Category (FAC) at baseline and session 6 (from 0 to 5, 0 being "patient cannot walk" and 5 "patient can walk independently anywhere")

Evaluate the patient's gait speed without the Atalante exoskeleton

Evaluation of the gait speed measured without the Atalante exoskeleton in 10-Meter Walk Test (10MWT) at baseline and session 6

Evaluate the patient's endurance without the Atalante exoskeleton

Evaluation of the covered distance without the Atalante exoskeleton measured in 6-Minute Walk Test (6MWT) at baseline and session 6

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

Evaluation of static and dynamic balance without the Atalante exoskeleton measured with the Berg Balance Scale (BBS) at baseline and session 6 (0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents good balance)

Evaluate the patient's spasticity

Evaluation of the spasticity of the adductor muscles, hamstrings, quadriceps, and triceps surae measured with Modified Ashworth Scale at baseline and session 6 0 No increase in muscle tone Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved Considerable increase in muscle tone, passive movement difficult Affected part(s) rigid in flexion or extension

Evaluate the patient's pain

Evaluation of the pain measured before and after sessions 1 to 5 using the Visual Analogical Scale-Pain. The patient is asked to make pain ratings between "No Pain" and "Maximum pain imaginable", , with "No pain" corresponding on 0 on the caregiver side and and "Maximum pain imaginable" to 10 on caregiver side.

Evaluate the patient's capability to stop the exoskeleton on time using the remote

Evaluation of the patient's capability to stop the exoskeleton, on time using the remote at session 5

Evaluate the patient's satisfaction and perceptions upon completion of a locomotor training program with the Atalante exoskeleton

Evaluation of the satisfaction et perceptions via a questionnaire specific to the use of robotics exoskeleton at session 6. Questions are answered on a 7-level Likert scale.

Evaluate the use of the Atalante exoskeleton

Collection of data relating to the patient's walking parameters and level of assistance with the Atalante exoskeleton during sessions 1 to 5

Evaluate the patient's skin condition to monitore the pressure points the patient may have with the contact of the exoskeleton.

The operator will perform a visual monitoring of the patient's skin to identify potential cutaneous morbidity at pressure points the patient may have with the exoskeleton before and after sessions 1 to 5.

Evaluate the patient's level of anxiety and depression

Assessment of patient anxiety and depression by means of the Hospital Anxiety and Depression (HAD) scale at baseline and one week after the 5th session

Full Information

NCT ID

NCT04694001

First Posted

December 28, 2020

Last Updated

April 26, 2022

Sponsor

Wandercraft

1. Study Identification

Unique Protocol Identification Number

NCT04694001

Brief Title

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

Acronym

INSPIRE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

April 12, 2021 (Actual)

Primary Completion Date

March 28, 2022 (Actual)

Study Completion Date

March 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wandercraft

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hemiplegia due to Cerebrovascular Accident (CVA)

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Use of the Atalante exoskeleton

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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).

Time Frame

Throughout study completion, an average of 6 days

Secondary Outcome Measure Information:

Title

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

Description

Evaluation of the walk performance with the Functional Ambulation Category (FAC) at baseline and session 6 (from 0 to 5, 0 being "patient cannot walk" and 5 "patient can walk independently anywhere")

Time Frame