AzTrials
AzTrials

Spinal Cord InjuriesNCT04110561

Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis

A study testing Use of the Atalante exoskeleton in people with Spinal Cord Injuries and Paraplegia, run by Wandercraft at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study is a prospective, open, bicentric and observational study. It is conducted to assess the safety and performance of the Atalante exoskeleton system with patients with lower limb paralysis. Read more about this study

Who is it for?
Ages 18 to 65 years
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
12 participants
Where
2 sitesFrance
Study dates
5 May 2018to 16 Nov 2018
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Motor complete traumatic Spinal Cord Injury (AIS A and B) since at least 4 months
  • Spinal Injury Level between AIS T5 and AIS T12
  • Able to verticalize on a daily basis
  • Height: between approximately 1.60 and 1.90 m. More specifically, Atalante is able to accommodate the following limb lengths:
  • Thigh: 380-460 mm
  • Distance between the ground and the joint space of the knee (to be measured while wearing the shoes they intend to wear with Atalante):
Show all 12Show fewer
  • 457-607 mm for patient with an ankle dorsiflexion ≥ 16°
  • 457-577 mm for patient with an ankle dorsiflexion between 13° et 16°
  • 457-567 mm for patient with an ankle dorsiflexion between 10° et 13°
  • 457-557 mm for patient with an ankle dorsiflexion between 0° et 10° o Hip width less of equal to 460 mm when seated
  • Maximum weight: 90 kg
  • Patient having given his written consent

Who cannot join

  • Patients whose joint centers cannot be aligned Atalante's
  • Ranges of motion below:
  • Hip: 115° flexion, 15° 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
  • Severe spasticity (greater than 3 on the modified Ashworth scale) of the adductor muscles, hamstrings, quadriceps and triceps surae
Show all 17Show fewer
  • Pregnant or lactating woman
  • Unbalanced psychiatric or cognitive status which may interfere with an appropriate use of the device
  • Other neurological disorder
  • History of osteoporotic fracture and/or disease or treatment responsible for a secondary osteoporosis
  • Active implantable medical device
  • Evolutive intercurrent disease: pressure sore, infection, venous thrombosis
  • Unstable and unhealed limb and pelvic fracture
  • Unstable spine
  • Severe illness which may interfere with the verticalized posture and tolerance to effort
  • Evolutive osteoma
  • Syringomyelia

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Centre Jacques Calvé - Fondation Hopale

    Berck, 62600

  • Centre mutualiste de Rééducation et de Réadaptation de Kerpape

    Ploemeur, 56270

Other trials in France

About this study

The study is a prospective, open, bicentric and observational study. It is conducted to assess the safety and performance of the Atalante exoskeleton system with patients with lower limb paralysis.

The principal objective is to assess the performance of the Atalante system in performing ambulatory functions with motor complete SCI patients characterized by the success rate in performing a 10mWT at the last session of training with the Atalante system.

Being tested
Use of the Atalante exoskeleton
Keywords
Spinal Cord Injuries, Paraplegia, Paralysis, Lower Limbs, Lower Extremity, Robotics, Physiotherapy, Rehabilitation, Powered Exoskeleton, Walking, Ambulation
Medical subject headings
Spinal Cord Injuries, Paraplegia

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 basically includes a stand up, walks over a distance of 10 meters, exercises, U-turns and a sitting

Study groups in NCT04110561
Study groupRoleWhat they receive
Spinal Cord Injury patients with motor complete paralysisOtherNot 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.

  1. The primary endpoint of the clinical investigation is defined by the success or failure at the 10 Meter Walk Test (10mWT) at the latest session.

    The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance.

    A clear pathway of at least 10-meter length is drawn. The start and the end point of a 10-m walkway is marked by lines.

    The patient starts a few steps prior the starting line; during the few steps needed to reach the starting line, the physiotherapist should stabilize the exoskeleton in the frontal plane. When the patient's first foot crosses the starting line, the test begins, and the stopwatch is started. The stopwatch is stopped at the end of the 10 meters in case of success, that is to say when the patient crosses the end line.

    The total time taken to ambulate is recorded. The distance covered is then divided by the total time (in seconds) taken to ambulate and recorded in meters per seconds.

    In case of failure, the distance walked by the patient is measured and recorded, and the speed to walk this distance is calculated as described above.

    Measured: At study completion, up to 3 weeks

Secondary outcomes (26)

  1. Capacity of patient in walking defined by Success / Failure on a 10mWT test at the 6th session.

    Measured: At study mid-term, 10 days in average

  2. The maximum distance walked during the 10mWT at the 6th and 12th sessions.

    Measured: At study mid-term, 10 days in average and at study completion, up to 3 weeks

  3. The average walking speeds during the 10mWT at the 6th and 12th sessions.

    Measured: At study mid-term, 10 days in average and at study completion, up to 3 weeks

  4. Capacity of the patient to perform verticalization as defined by the test "Stand-up" at the 6th and 12th sessions.

    Measured: At study mid-term, 10 days in average and at study completion, up to 3 weeks

  5. Capacity of a standing patient to reach a sitting position as defined by the test "Sit down" at the 6th and 12th sessions.

    Measured: At study mid-term, 10 days in average and at study completion, up to 3 weeks

  6. Ability of the patient to maintain a stand still position for 2 minutes as defined by the test "Stand without support for 2 minutes" at the 6th and 12th sessions.

    Measured: At study mid-term, 10 days in average and at study completion, up to 3 weeks

  7. Ability of the patient to lean with extended arm in a standing position (90° arms) at the 6th and 12th sessions.

    Measured: At study mid-term, 10 days in average and at study completion, up to 3 weeks

  8. Ability of the patient to perform a U-turn in less than 3 minutes as defined by the test "Make a U-turn" at the 6th and 12th sessions.

    Measured: At study mid-term, 10 days in average and at study completion, up to 3 weeks

  9. Average scores on Borg CR-10 simple perception scale for the perceived exertion at the 6th and 12th sessions.

    Rating of perceived exertion (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.

    Developed by Gunnar Borg, it is often also referred to as the Borg Scale. Despite being a subjective measure of exercise intensity, RPE scales provide valuable information when used correctly.

    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

    Measured: At study mid-term, 10 days in average and at study completion, up to 3 weeks

  10. Average scores of safety perceived by the patient on a 7-point Likert scale 7 levels at the 6th and 12th sessions.

    A Likert scale is a psychometric scale commonly involved in research based on survey questionnaires. Here, the respondents specify their level of agreement or disagreement using a symmetric agree-disagree scale for a series of statements while responding to a particular Likert questionnaire item. The range of Likert scale captures the intensity of their feelings for a given item.

    The Likert scale ratings are:

    1. Strongly disagree
    2. Disagree
    3. Disagree somewhat
    4. Neither agree nor disagree
    5. Agree somewhat
    6. Agree
    7. Strongly agree

    The perceived safety is evaluated with the 7-point Likert scale on the following statement:

    "I felt safe during the test"

    Measured: At study mid-term, 10 days in average and at study completion, up to 3 weeks

  11. Observation of the skin condition was made before and after each session on the subject's back, thighs, knees and feet.

    Measured: Throughout study completion, an average of 3 weeks

  12. Comparison of the NBD score before the 1st session and after the 12th session.

    The neurogenic bowel dysfunction score is a questionnaire including questions about background parameters, faecal incontinence, constipation, obstructed defecation, and impact on quality of life. The NBD score is constructed from items with acceptable reproducibility and validity that were significantly associated with impact on quality of life. The type of the stool depends on the time it spends in the colon.

    Measured: At study start, day 1 and at study completion, up to 3 weeks

  13. Comparison of the Bristol scale before the 1st session and after the 12th session.

    The Bristol Stool Chart is:

    • Type 1: Separate hard lumps, like nuts (hard to pass);
    • Type 2: Sausage-shaped but lumpy;
    • Type 3: Like a sausage but with cracks on its surface;
    • Type 4: Like a sausage or snake, smooth and soft;
    • Type 5: Soft blobs with clear-cut edges (passed easily);
    • Type 6: Fluffy pieces with ragged edges, a mushy stool;
    • Type 7: Watery, no solid pieces. Entirety liquid.

    Type 1, 2 and 3 indicate constipation. Type 4 and 5 are ideal stools. Type 6 and 7 indicate diarrhea and urgency.

    Measured: At study start, day 1 and at study completion, up to 3 weeks

  14. Definition of the voiding mode at the 1st and 12th sessions.

    The management of neurogenic bladder dysfunction is crucial in the management of paraplegic patients as it affects the morbidity of these patients. The voiding mode is described. The self-survey is the standard treatment when the subject has an overactive bladder. The mictionnel mode will be informed before the first session, and at the end of the last session with the exoskeleton using an ISCOS questionnaire (International Spinal Cord Society questionnaire).

    Measured: At study start, day 1 and at study completion, up to 3 weeks

  15. Qualiveen score at the 1st and 12th sessions.

    The Qualiveen score is developed as a condition-specific quality of life measurement for individuals with SCI who have urinary disorders. It contains 4 domains:

    • Limitation/ Inconvenience;
    • Constrains/ Restrictions;
    • Fears;
    • Feelings/ Impact on Daily Life.

    The test-retest reliability is high6.

    Measured: At study start, day 1 and at study completion, up to 3 weeks

  16. Spasticity according to the Modified Ashworth scale at the 1st and 12th sessions.

    The Modified Ashworth Scale measures spasticity in patients with lesion of the Central Nervous System. The relationship between the raters' judgments was significant and the reliability was good. (PMID: 3809245)

    The scoring is:

    • 0: No increase in muscle tone
    • 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
    • 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
    • 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
    • 3: Considerable increase in muscle tone, passive movement difficult
    • 4: Affected part(s) rigid in flexion or extension

    Muscles evaluated are adductor, hamstring, triceps sural and quadriceps.

    Measured: At study start, day 1 and at study completion, up to 3 weeks

  17. Heart rate measurement at rest and after the 10mWT at the 1st, 6th and 12th sessions.

    Measured: At study start, day 1, at study mid-term, 10 days and at study completion, up to 3 weeks

  18. Comparison of the Visual Analogue Pain Scale at the 1st and 12th sessions.

    The Numeric Pain Rating Scale measures the subjective intensity of pain. The NPRS is an 11-points scale from 0 to 10: "0" = no pain; "10" = the most intense pain imaginable.

    The subject is asked to make pain rating corresponding to the current pain experienced.

    Measured: At study start, day 1 and at study completion, up to 3 weeks

  19. Comparison of the NPSI scores at the 1st and 12th sessions.

    NPSI (Neuropathic Pain Sumptom Inventory) renders it suitable for the evaluation of the different dimensions of neuropathic pain syndromes. The reliability of the different descriptors appears to be sufficient.

    It allows to quantify the various pain symptoms that can be grouped into five dimensions (burn, deep pain, paroxysmal pain, pain caused, paresthesia / dysesthesia)

    Measured: At study start, day 1 and at study completion, up to 3 weeks

  20. Patient Global Impression of Improvement (PGI-I) at the 12th session.

    The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of the use of Atalante on the bowel function.

    The subject should check the number that best describes how the twelfth session condition is, compared with how it has been at the first session for the bowel function:

    1. Very much better
    2. Much better
    3. A little better
    4. No change
    5. A little worse
    6. Much worse
    7. Very much worse

    Measured: At study completion, up to 3 weeks

  21. Average scores of the 7-point Likert scale for ergonomics at the 12th session.

    At the end of the twelfth session, the patient evaluates the interfaces and the ergonomics of Atalante (shape of the remote, mode, symbol) and the perceived safety and the level of assistance during transfer from the wheelchair to Atalante with a Likert scale.

    The Likert scale is a questionnaire where the subject chooses among seven-point scales:

    1. Strongly disagree
    2. Disagree
    3. Disagree somewhat
    4. Neither agree nor disagree
    5. Agree somewhat
    6. Agree
    7. Strongly agree

    Measured: At study completion, up to 3 weeks

  22. Time of installation of the patient in the exoskeleton at the 12th session.

    Measured: At study completion, up to 3 weeks

  23. Assistance level for each fastener at the 12th session.

    The level of assistance is specified for each attachment (thigh, knee and foot straps). The levels of assistance are:

    • Without assistance;
    • With the assistance of one health professional;
    • With the assistance of two health professional.

    Measured: At study completion, up to 3 weeks

  24. Average scores of the 7-point Likert scale for exoskeleton attachment questionnaire at the 12th session.

    At the end of the twelfth session, the strapping system is evaluated using a 7-point Likert scale:

    1. Strongly disagree
    2. Disagree
    3. Disagree somewhat
    4. Neither agree nor disagree
    5. Agree somewhat
    6. Agree
    7. Strongly agree

    Measured: At study completion, up to 3 weeks

  25. Evaluation of sitting balance using the Boubee test at the 1st and 12th sessions.

    This test evaluates the ability of the subject to balance in sitting position during disturbances induced by movements of the upper limbs. The subject is sitting without back's support and with both feet on the ground. The subject is asked to do six tasks from the easiest to the hardest. The subject must pass the task to test the next task. The score is defined by the last passed task. The sitting balance is evaluated at the first and at the last session.

    Measured: At study start, day 1 and at study completion, up to 3 weeks

  26. Adverse events collection at each session.

    Measured: Throughout study completion, an average of 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study start5 May 2018
  3. Primary completion16 Nov 2018
  4. Study completion16 Nov 2018

Resources

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04110561
Sponsor's protocol ID
TPL005
Status last verified
Oct 2019
First submitted
26 Sep 2019
Last updated
7 Oct 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Use of the Atalante exoskeleton in people with Spinal Cord Injuries and Paraplegia, run by Wandercraft at 2 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 12 inclusion and 17 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 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The primary endpoint of the clinical investigation is defined by the success or failure at the 10 Meter Walk Test (10mWT) at the latest session. (time frame: At study completion, up to 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04110561.

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 7 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in