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

Stroke Clinical Trial

— SPIRIT  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04187209
• Other study ID #: SPIRIT
• Status: Completed
• Phase: N/A
• Start date: September 11, 2019
• Est. completion date: January 13, 2021

Study information

• Verified date: November 2022
• Source: Wandercraft
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The SPIRIT study is interventional, national, prospective, open, bicentric 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 16 patients and takes place in two french rehabilitation centers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 13, 2021
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Non-walking patient (FAC score at 0 or 1) with non-traumatic vascular hemiplegia in acute subacute phase (15 days to 3 months) hospitalized in rehabilitation center,
• Patient with ischemic stroke of which etiological evaluation is complete,
• Adult patient =18 years old and <75 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.

Related Conditions & MeSH terms

• Hemiplegia
• Robotics
• Stroke
• Stroke, Acute
• Stroke, Subacute

Intervention

Device:
• Use of the Atalante exoskeleton
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.

Locations

Country	Name	City	State
France	Centre Jacques Calvé - Fondation Hopale	Berck
France	Centre mutualiste de Rééducation et de Réadaptation de Kerpape	Ploemeur

Sponsors (1)

Lead Sponsor	Collaborator
Wandercraft

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Evaluate the patient's ambulatory ability without the Atalante exoskeleton with the Functional Ambulation Classification.	Evaluation of the walk performance with the FAC classification.; 0: Nonfunctional ambulation; Ambulator-Dependent for Physical Assistance Level II; Ambulator-Dependent for Physical Assistance Level I; Ambulator-Dependent for Supervision; Ambulator-Independent Level Surfaces only; Ambulator-Independent	At baseline, day 0 and at study completion, up to 10 days
Secondary	Evaluate the settings of the walking parameters of the exoskeleton deemed most efficient by the patient (step length, cadence)	During sessions 2 to 5, the physiotherapist will vary the step length and cadence of the exoskeleton's walk.; Each parameter will be tested over a distance of 10 meters. Perceived exertion and perceived safety will be assessed by the patient using a Likert Scale. Physiotherapist satisfaction (evaluated on a Likert Scale) will be assessed at the end of the test.; Likert scale : "strongly disagree"; "disagree"; "neither agree or disagree",; "agree",; "strongly agree",	At study start, day 2 until study mid term, day 5
Secondary	Evaluate the assistive control settings	The test is performed in EXERCISE mode. Atalante accompanies the movements of the upper body while stabilizing the entire system.; As a result of this transfer, a quasi-static step is triggered. This step is more or less assisted: the effort provided by the patient is modulated by the physiotherapist (100% of assistance equals 0% effort of the patient, Atalante performs the movement instead of the patient). The patient takes a step forward and at the end of the step, Atalante returns to the EXERCISE mode and is ready to connect a second quasi-static step by soliciting the opposite leg. The patient has to transfer his/her weight for 2 seconds on the opposite leg to trigger the step.; Values of tested assistance levels assessed will be collected as perceived exertion, perceived safety and physiotherapist satisfaction (evaluated on a Likert Scale).; Likert scale : "strongly disagree"; "disagree"; "neither agree or disagree",; "agree",; "strongly agree",	At study start, day 2
Secondary	Evaluate the assistive control settings	The test of dynamic assistance is performed in WALK mode. The patient starts by leaning the right side (or left side). Then, as soon as the user presses WALK button, a first step is triggered by the exoskeleton. Next steps are more or less assisted depending on the level of assistance chosen by the physiotherapist (100% of assistance equals 0% effort of the patient, Atalante performs the movement instead of the patient). The patient must initiate each step by pushing on the opposite leg and making a pelvic rotation towards the forward foot.; Values of tested assistance levels assessed will be collected as perceived exertion, perceived safety and physiotherapist satisfaction (evaluated on a Likert Scale).; Likert scale : "strongly disagree"; "disagree"; "neither agree or disagree",; "agree",; "strongly agree",	Study mid term, day 4
Secondary	Evaluate the patient's ability to perform weight transfer on the hemiplegic side or the healthy side	Success/ Failure to the exercise: transfer of weight to the right or left side until the sound signal is triggered	At study start, day 2 until study mid term, day 4
Secondary	Evaluate the patient's ability to perform a semi-squat	Success/ Failure to the exercise: perform a semi-squat	At study start, day 3 until study mid term, day 5
Secondary	Evaluate the patient's ability to perform functional tests with the Atalante exoskeleton with a Time Up and Go test	Success/ Failure to the TUG test (Time Up and Go test)	At study mid-term, day 7 until study completion, day 9
Secondary	Evaluate the level of assistance needed by the patient from the healthcare staff to perform tests	The therapist will record the level(s) of assistance needed to perform each test and detail the moment on which assistance was needed during the test. The level of assistance will be determined with the number of times the therapist will have helped the patient during the tests, as well as the type of assistance he/she will have provided.; The physiotherapist will select on a scale the level of assistance he/she provided during the test:. None (0% of assistance) - Minimal (0-25% assistance) - Moderate (25-50% assistance) - High (50-75% assistance) - Maximum (75-100% assistance).	Throughout study completion, an average of 10 days
Secondary	Evaluate the time needed for the patient to don and doff	Collection of data regarding the time needed for patient to donning and doff	At study completion, day 10
Secondary	Evaluate the patient's physical and cognitive conditions using the Berg Balance Scale	The Berg Balance Scale (BBS) is a 14-item objective measure that assesses static balance and risk of fall in adult. In this 14-item scale, patient must maintain positions and complete moving tasks of varying difficulty. In most items, patient must maintain a given position for a specified time. Patient receives a score from 0-4 on his/her ability to meet these balance dimensions: 0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents good balance. This measure will be performed during sessions 0 and 10 in order to assess a potential variation.	At baseline, day 0 and at study completion, up to 10 days
Secondary	Evaluate the patient's physical and cognitive conditions	Evaluation of the level of aphasia by the aphasia severity rating scale from the Boston Diagnostic Aphasia Examination.; The degree of aphasia will be evaluated using the aphasia severity rating scale from the Boston Diagnostic Aphasia Examination (BDAE). BDAE is designed to diagnose aphasia and related disorders. This test evaluates the various conceptual modalities (auditory, visual and gestural), the processing functions (comprehension, analysis, problem solving) and the response modalities (writing, articulation and manipulation).; The aphasia severity rating scale from the BDAE will be done at baseline in order to describe the population participating in the study.	At baseline, day 0
Secondary	Evaluate the safety of the exoskeleton by collecting the incidence of points of contact, induced pain, edema, and other potential adverse events	Collection of medical events relating to cutaneous, algological and infectious morbidity	Throughout study completion, an average of 10 days
Secondary	Evaluate the level of effort perceived during each test by using the Borg scale	Rating of perceived exertion (RPE) will be used to assess the effort perceived by patient at each session. RPE is a widely used and reliable indicator to monitor and guide exercise intensity. The scale allows individuals to subjectively rate their level of exertion during exercise or exercise testing.; The revised category-ratio scale (0 to 10 scale) is used: 0 Null; 1 Very easy; 2 Somewhat easy-; 3 Moderate; 4 Somewhat hard; 5 Hard; 6; 7 Very hard; 8; 9; 10 Very, very hard	Throughout study completion, an average of 10 days
Secondary	Evaluate the level of security perceived during each test by using a 5-level Likert scale	Perceived safety during tests will be assessed by each patient using a 5-point Likert scale format ranging from 5)"strongly agree", 4)"agree", 3)"neither agree or disagree", 2)"disagree" and 1)"strongly disagree".; The range of Likert scale captures the intensity of his/her feeling for a given item	Throughout study completion, an average of 10 days
Secondary	Evaluate the level of anxiety of patient related to the use of the exoskeleton	Collection of the patient's level of anxiety assessed by a 5-level Likert scale: "strongly disagree"; "disagree"; "neither agree or disagree",; "agree",; "strongly agree",	At study start, day 1 and at study completion, up to 10 days
Secondary	Evaluate the emergence of musculoskeletal disorders in the therapist	Evaluation of musculoskeletal disorders developed by healthcare professionals in the use of exoskeleton with a Nordic style questionnaire.; The Nordic Musculoskeletal Questionnaire (NMQ) is a 2-section questionnaire. The aim was to develop and test a standardized questionnaire methodology allowing comparison of low back, neck, shoulder and general complaints.; The NMQ can be used as a questionnaire or as a structured interview.	At baseline, day 0 and at study completion, up to 10 days