StrokeSPIRITNCT04187209
Evaluation of the Use of the Atalante System in Patients Presenting a Non-traumatic Hemiplegia in Acute-subacute Phase (15 Days to 6 Months).
A study testing Use of the Atalante exoskeleton in people with Stroke and Stroke, Acute, run by Wandercraft at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Acute, Stroke, Subacute
- What is being tested?
- Use of the Atalante exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesFrance
- Study dates
- 11 Sep 2019to 13 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
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- 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.
Who cannot join
- 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
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- 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 locations and contacts
3 sites in 1 country.
France3 sites
Centre Jacques Calvé - Fondation Hopale
Berck, 62600
Centre de Médecine Physique et de Réadaptation de Pionsat
Pionsat, 63330
Centre mutualiste de Rééducation et de Réadaptation de Kerpape
Ploemeur, 56270
About this study
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
- Being tested
- Use of the Atalante exoskeleton
- Keywords
- Stroke, Acute Stroke, Subacute Stroke, Robotics, Physiotherapy, Rehabilitation, Powered exoskeleton, Walking, Exercises, Ambulation
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the Atalante exoskeletonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-traumatic hemiplegia in post stroke acute subacute phase | Other | Not described Receives: Device: Use of the Atalante exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
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
Measured: 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)
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"
Measured: Day 2 until study mid term, day 5
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",
Measured: Day 2, day 4
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
Measured: Day 2, day 4
Evaluate the patient's ability to perform a semi-squat
Success/ Failure to the exercise: perform a semi-squat
Measured: Day 3, day 5
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).
Measured: Throughout study completion, an average of 10 days
Evaluate the time needed for the patient to don and doff
Collection of data regarding the time needed for patient to donning and doff
Measured: At study completion, day 10
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
Measured: At baseline, day 0 and at study completion, up to 10 days
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.
Measured: At baseline, day 0
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
- Very easy
- Somewhat easy-
- Moderate
- Somewhat hard
- Hard
7 Very hard 8 9 10 Very, very hard
Measured: Throughout study completion, an average of 10 days
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.
Measured: Throughout study completion, an average of 10 days
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",
Measured: At study start, day 1 and at study completion, up to 10 days
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.
Measured: At baseline, day 0 and at study completion, up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start11 Sep 2019
- Primary completion13 Jan 2021
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wandercraft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacques Kerdraon, Dr, Principal investigator, Centre mutualiste de Rééducation et de Réadaptation de KerpapeJean-Gabriel Prévinaire, Dr, Principal investigator, Centre Jacques Calvé - Fondation Hopale de Berck-sur-MerSoultana Tatsidou, Dr, Principal investigator, Centre de Médecine Physique et de Réadaptation de Pionsat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187209
- Sponsor's protocol ID
- SPIRIT
- Acronym
- SPIRIT
- Status last verified
- Sep 2024
- First submitted
- 15 Nov 2019
- Last updated
- 26 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04187209
- Acronym / sponsor ID
- SPIRIT / SPIRIT
- Conditions
- Stroke, Stroke, Acute, Stroke, Subacute, Robotics
- Keywords
- Stroke, Acute Stroke, Subacute Stroke, Robotics, Physiotherapy, Rehabilitation, Powered exoskeleton, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- WandercraftIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-traumatic hemiplegia in post stroke acute subacute phase | Other | Device: Use of the Atalante exoskeleton |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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,
Key exclusion criteria (13 listed)
- Ranges of motion below:
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of the Atalante exoskeletonA 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. | Device | Non-traumatic hemiplegia in post stroke acute subacute phase |
Primary outcome
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.
Time frame: At study mid-term, 6 days in average
Defined by the patient's ability to perform the 10mWT with the Atalante system.
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.
Time frame: At study mid-term, 7 days in average
Defined by the patient's ability to perform the 10mWT with the Atalante system
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.
Time frame: At study mid-term, 8 days in average
Defined by the patient's ability to perform the 10mWT with the Atalante system
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.
Time frame: At study completion, 9 days in average
Defined by the patient's ability to perform the 10mWT with the Atalante system
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.
Time frame: At study completion, 10 days in average
Defined by the patient's ability to perform the 10mWT with the Atalante system
13 secondary outcomes
Evaluate the patient's ambulatory ability without the Atalante exoskeleton with the Functional Ambulation Classification (FAC).
Time frame: 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)
Time frame: Day 2 until study mid term, day 5
Evaluate the assistive control settings
Time frame: Day 2, day 4
Evaluate the patient's ability to perform weight transfer on the hemiplegic side or the healthy side
Time frame: Day 2, day 4
Evaluate the patient's ability to perform a semi-squat
Time frame: Day 3, day 5
Evaluate the level of assistance needed by the patient from the healthcare staff to perform tests
Time frame: Throughout study completion, an average of 10 days
Evaluate the time needed for the patient to don and doff
Time frame: At study completion, day 10
Evaluate the patient's physical and cognitive conditions using the Berg Balance Scale
Time frame: At baseline, day 0 and at study completion, up to 10 days
Evaluate the patient's physical and cognitive conditions
Time frame: At baseline, day 0
Evaluate the level of effort perceived during each test by using the Borg scale
Time frame: Throughout study completion, an average of 10 days
Evaluate the level of security perceived during each test by using a 5-level Likert scale
Time frame: Throughout study completion, an average of 10 days
Evaluate the level of anxiety of patient related to the use of the exoskeleton
Time frame: At study start, day 1 and at study completion, up to 10 days
Evaluate the emergence of musculoskeletal disorders in the therapist
Time frame: At baseline, day 0 and at study completion, up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Kerdraon, Dr principal investigator
Centre mutualiste de Rééducation et de Réadaptation de Kerpape
Jean-Gabriel Prévinaire, Dr principal investigator
Centre Jacques Calvé - Fondation Hopale de Berck-sur-Mer
Soultana Tatsidou, Dr principal investigator
Centre de Médecine Physique et de Réadaptation de Pionsat
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the Atalante exoskeleton in people with Stroke and Stroke, Acute, run by Wandercraft at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: At study mid-term, 6 days in average). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.