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

Wandercraft

Status: Completed

Conditions: Stroke, Subacute; Robotics; Stroke; Stroke, Acute

Treatments: Device: Use of the Atalante exoskeleton

Study type: Interventional

Funder types: Industry

Identifiers

NCT04187209

SPIRIT

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 with stable medical condition at the time of inclusion in the study (absence of infectious and cardiorespiratory events),

• 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):

    • 45.7-60.7 cm for patient with an ankle dorsiflexion ≥ 16°
    • 45.7-57.7 cm for patient with an ankle dorsiflexion > 13° et < 16°
    • 45.7-56.7 cm for patient with an ankle dorsiflexion > 10° et ≤ 13°
    • 45.7-55.7 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,

• Patient able to read and write French and who have signed an informed consent form.

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Non-traumatic hemiplegia in post stroke acute subacute phase

Other group

Treatment:

Device: Use of the Atalante exoskeleton