Evaluation of the Use of the Atalante System in Patients Presenting a Non-traumatic Hemiplegia in Acute-subacute Phase (15 Days to 6 Months).

NCT04187209 | Completed

• 1 other identifier: SPIRIT
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

The SPIRIT study is interventional, national, 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 a non-traumatic acute-subacute hemiplegia. The primary endpoint is defined by the patient's ability to perform the 10 MWT with the Atalante system. The study will include at least 12 patients and takes place in three french rehabilitation centers.

Conditions

Stroke; Stroke, Acute; Stroke, Subacute; Robotics

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Evaluate the use of the Atalante system in patients with non-traumatic acute-subacute hemiplegia over several sessions with a 10 meter Walk Test. This test will show the incidence of test success and emergence of adverse events.

  Defined by the patient's ability to perform the 10mWT with the Atalante system.

  At study mid-term, 6 days in average

• Evaluate the use of the Atalante system in patients with non-traumatic acute-subacute hemiplegia over several sessions with a 10 meter Walk Test. This test will show the incidence of test success and emergence of adverse events.

  Defined by the patient's ability to perform the 10mWT with the Atalante system

  At study mid-term, 7 days in average

• Evaluate the use of the Atalante system in patients with non-traumatic acute-subacute hemiplegia over several sessions with a 10 meter Walk Test. This test will show the incidence of test success and emergence of adverse events.

  Defined by the patient's ability to perform the 10mWT with the Atalante system

  At study mid-term, 8 days in average

• Evaluate the use of the Atalante system in patients with non-traumatic acute-subacute hemiplegia over several sessions with a 10 meter Walk Test. This test will show the incidence of test success and emergence of adverse events.

  Defined by the patient's ability to perform the 10mWT with the Atalante system

  At study completion, 9 days in average

• Evaluate the use of the Atalante system in patients with non-traumatic acute-subacute hemiplegia over several sessions with a 10 meter Walk Test. This test will show the incidence of test success and emergence of adverse events.

  Defined by the patient's ability to perform the 10mWT with the Atalante system

  At study completion, 10 days in average

Secondary Outcomes (13)

• Evaluate the patient's ambulatory ability without the Atalante exoskeleton with the Functional Ambulation Classification (FAC).

  At baseline, day 0 and at study completion, up to 10 days

• Evaluate the settings of the walking parameters of the exoskeleton deemed most efficient by the patient (step length, cadence)

  Day 2 until study mid term, day 5

• Evaluate the assistive control settings

  Day 2, day 4

• Evaluate the patient's ability to perform weight transfer on the hemiplegic side or the healthy side

  Day 2, day 4

• Evaluate the patient's ability to perform a semi-squat

  Day 3, day 5

Study Arms (1)

Non-traumatic hemiplegia in post stroke acute subacute phase

OTHER

Device: Use of the Atalante exoskeleton

Interventions

Use of the Atalante exoskeleton DEVICE

A session includes a stand-up, walks over a distance of 10 meters, exercises with or without the assistance of the exoskeleton, U-turns and a sitting.

Non-traumatic hemiplegia in post stroke acute subacute phase

Eligibility Criteria

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

You may qualify if:

• Patient with non-traumatic vascular hemiplegia in acute subacute phase (15 days to 6 months) hospitalized in rehabilitation center,
• Patients presenting a FAC score of 0, 1 or 2,
• Patient with ischemic or hemorrhagic stroke of which etiological evaluation is complete,
• Adult patient ≥18 years old,
• Patient able to verticalize on a daily basis and having a stabilized blood pressure,
• Patient's height is at least 1m55,
• Lengths of patient's lower limb are in the following intervals:
• Thigh (distance gluteus maximus - patella): 56.8 and 64.8 cm,
• Distance between the ground and the joint space of the knee (to be measured while wearing the shoes the patient intends to wear with Atalante):
• cm for patient with an ankle dorsiflexion ≥ 16°
• cm for patient with an ankle dorsiflexion \> 13° et \< 16°
• cm for patient with an ankle dorsiflexion \> 10° et ≤ 13°
• cm for patient with an ankle dorsiflexion ≥ 0° et ≤ 10°
• Intertrochanteric distance lower or equal to 46.0 cm when seated,
• Maximum weight: 90 kg,

You may not qualify if:

• Ranges of motion below:
• Hip: 90° flexion, 5° extension, 17° abduction, 10° adduction, 10° medial rotation, 20° lateral rotation
• Knee: 5° extension, 110° flexion
• Ankle: 0° dorsiflexion, 9° plantar flexion, 18° inversion and eversion
• Patient whose joint centers cannot be aligned Atalante's system,
• Severe spasticity (greater than 3 on the modified Ashworth scale) of the adductor muscles, hamstrings, quadriceps and triceps surae
• Pregnant or lactating women,
• Medical history of osteoporotic fracture and/or disease or treatment responsible for a secondary osteoporosis,
• Patient with a cardiac contraindication to physical exertion,
• Evolutive intercurrent disease: venous thrombosis, hypotension,
• Patient unable to deliver his/her consent,
• Patient under legal protection,
• Patient participating at the same time in another study.

Sponsors & Collaborators

• Wandercraft: lead

Study Sites (3)

Centre Jacques Calvé - Fondation Hopale

Berck, 62600, France

Location

Centre de Médecine Physique et de Réadaptation de Pionsat

Pionsat, 63330, France

Location

Centre mutualiste de Rééducation et de Réadaptation de Kerpape

Ploemeur, 56270, France

Location

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 Officials

• Jacques Kerdraon, Dr

  Centre mutualiste de Rééducation et de Réadaptation de Kerpape

  PRINCIPAL INVESTIGATOR

• Jean-Gabriel Prévinaire, Dr

  Centre Jacques Calvé - Fondation Hopale de Berck-sur-Mer

  PRINCIPAL INVESTIGATOR

• Soultana Tatsidou, Dr

  Centre de Médecine Physique et de Réadaptation de Pionsat

  PRINCIPAL INVESTIGATOR

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: November 15, 2019
• First Posted: December 5, 2019
• Study Start: September 11, 2019
• Primary Completion: January 13, 2021
• Study Completion: January 13, 2021
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

FR (3)