Clinical trial NCT04187209: Evaluation of the Use of the Atalante System in Patients Presenting a Non-traumatic Hemiplegia in Acute-subacute Phase (15 Days to 6 Months).
Official title: Evaluation of the Use of the Atalante System in Patients Presenting a Non-traumatic Hemiplegia in Acute-subacute Phase (15 Days to 6 Months).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Stroke, Acute
Stroke, Subacute
Robotics
Keywords: Stroke
Acute Stroke
Subacute Stroke
Robotics
Physiotherapy
Rehabilitation
Powered exoskeleton
Walking
Exercises
Ambulation
Lead sponsor: Wandercraft
Sponsor class: INDUSTRY
First posted: 2019-12-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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 \&gt; 13° et \&lt; 16°
    * 45.7-56.7 cm for patient with an ankle dorsiflexion \&gt; 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.

Primary outcomes:
measure: 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.
timeFrame: At study mid-term, 6 days in average
measure: 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.
timeFrame: At study mid-term, 7 days in average
measure: 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.
timeFrame: At study mid-term, 8 days in average
measure: 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.
timeFrame: At study completion, 9 days in average
measure: 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.
timeFrame: At study completion, 10 days in average
Secondary outcomes:
measure: Evaluate the patient's ambulatory ability without the Atalante exoskeleton with the Functional Ambulation Classification (FAC).
timeFrame: At baseline, day 0 and at study completion, up to 10 days
measure: Evaluate the settings of the walking parameters of the exoskeleton deemed most efficient by the patient (step length, cadence)
timeFrame: Day 2 until study mid term, day 5
measure: Evaluate the assistive control settings
timeFrame: Day 2, day 4
measure: Evaluate the patient's ability to perform weight transfer on the hemiplegic side or the healthy side
timeFrame: Day 2, day 4
measure: Evaluate the patient's ability to perform a semi-squat
timeFrame: Day 3, day 5
measure: Evaluate the level of assistance needed by the patient from the healthcare staff to perform tests
timeFrame: Throughout study completion, an average of 10 days
measure: Evaluate the time needed for the patient to don and doff
timeFrame: At study completion, day 10
measure: Evaluate the patient's physical and cognitive conditions using the Berg Balance Scale
timeFrame: At baseline, day 0 and at study completion, up to 10 days
measure: Evaluate the patient's physical and cognitive conditions
timeFrame: At baseline, day 0
measure: Evaluate the level of effort perceived during each test by using the Borg scale
timeFrame: Throughout study completion, an average of 10 days
measure: Evaluate the level of security perceived during each test by using a 5-level Likert scale
timeFrame: Throughout study completion, an average of 10 days
measure: Evaluate the level of anxiety of patient related to the use of the exoskeleton
timeFrame: At study start, day 1 and at study completion, up to 10 days
measure: Evaluate the emergence of musculoskeletal disorders in the therapist
timeFrame: At baseline, day 0 and at study completion, up to 10 days
Other outcomes:
Locations:
city: Berck
country: France
facility: Centre Jacques Calvé - Fondation Hopale
city: Pionsat
country: France
facility: Centre de Médecine Physique et de Réadaptation de Pionsat
city: Ploemeur
country: France
facility: Centre mutualiste de Rééducation et de Réadaptation de Kerpape
Study officials:
affiliation: Centre mutualiste de Rééducation et de Réadaptation de Kerpape
name: Jacques Kerdraon, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Jacques Calvé - Fondation Hopale de Berck-sur-Mer
name: Jean-Gabriel Prévinaire, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de Médecine Physique et de Réadaptation de Pionsat
name: Soultana Tatsidou, Dr
role: PRINCIPAL_INVESTIGATOR
References: