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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110561
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Wandercraft

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Paraplegia Paralysis, Lower Limbs Lower Extremity Robotics Device: Use of the Atalante exoskeleton Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis
Actual Study Start Date : May 5, 2018
Actual Primary Completion Date : November 16, 2018
Actual Study Completion Date : November 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Arm Intervention/treatment
Spinal Cord Injury patients with motor complete paralysis Device: Use of the Atalante exoskeleton
A session basically includes a stand up, walks over a distance of 10 meters, exercises, U-turns and a sitting




Primary Outcome Measures :
  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. [ Time Frame: At study completion, up to 3 weeks ]

    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.



Secondary Outcome Measures :
  1. Capacity of patient in walking defined by Success / Failure on a 10mWT test at the 6th session. [ Time Frame: At study mid-term, 10 days in average ]
  2. The maximum distance walked during the 10mWT at the 6th and 12th sessions. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: At study mid-term, 10 days in average and at study completion, up to 3 weeks ]

    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

  10. Average scores of safety perceived by the patient on a 7-point Likert scale 7 levels at the 6th and 12th sessions. [ Time Frame: At study mid-term, 10 days in average and at study completion, up to 3 weeks ]

    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"


  11. Observation of the skin condition was made before and after each session on the subject's back, thighs, knees and feet. [ Time Frame: Throughout study completion, an average of 3 weeks ]
  12. Comparison of the NBD score before the 1st session and after the 12th session. [ Time Frame: At study start, day 1 and at study completion, up to 3 weeks ]
    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.

  13. Comparison of the Bristol scale before the 1st session and after the 12th session. [ Time Frame: At study start, day 1 and at study completion, up to 3 weeks ]

    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.


  14. Definition of the voiding mode at the 1st and 12th sessions. [ Time Frame: At study start, day 1 and at study completion, up to 3 weeks ]
    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).

  15. Qualiveen score at the 1st and 12th sessions. [ Time Frame: At study start, day 1 and at study completion, up to 3 weeks ]

    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.


  16. Spasticity according to the Modified Ashworth scale at the 1st and 12th sessions. [ Time Frame: At study start, day 1 and at study completion, up to 3 weeks ]

    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.


  17. Heart rate measurement at rest and after the 10mWT at the 1st, 6th and 12th sessions. [ Time Frame: 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. [ Time Frame: At study start, day 1 and at study completion, up to 3 weeks ]

    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.


  19. Comparison of the NPSI scores at the 1st and 12th sessions. [ Time Frame: At study start, day 1 and at study completion, up to 3 weeks ]

    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)


  20. Patient Global Impression of Improvement (PGI-I) at the 12th session. [ Time Frame: At study completion, up to 3 weeks ]

    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

  21. Average scores of the 7-point Likert scale for ergonomics at the 12th session. [ Time Frame: At study completion, up to 3 weeks ]

    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

  22. Time of installation of the patient in the exoskeleton at the 12th session. [ Time Frame: At study completion, up to 3 weeks ]
  23. Assistance level for each fastener at the 12th session. [ Time Frame: At study completion, up to 3 weeks ]

    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.

  24. Average scores of the 7-point Likert scale for exoskeleton attachment questionnaire at the 12th session. [ Time Frame: At study completion, up to 3 weeks ]

    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

  25. Evaluation of sitting balance using the Boubee test at the 1st and 12th sessions. [ Time Frame: At study start, day 1 and at study completion, up to 3 weeks ]
    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.

  26. Adverse events collection at each session. [ Time Frame: Throughout study completion, an average of 3 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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):

      • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110561


Locations
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France
Centre Jacques Calvé - Fondation Hopale
Berck, France, 62600
Centre mutualiste de Rééducation et de Réadaptation de Kerpape
Ploemeur, France, 56270
Sponsors and Collaborators
Wandercraft
Investigators
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Principal Investigator: Jacques Kerdraon, Dr Centre mutualiste de Rééducation et de Réadaptation de Kerpape
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Responsible Party: Wandercraft
ClinicalTrials.gov Identifier: NCT04110561    
Other Study ID Numbers: TPL005
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wandercraft:
Spinal Cord Injuries
Paraplegia
Paralysis, Lower Limbs
Lower Extremity
Robotics
Physiotherapy
Rehabilitation
Powered Exoskeleton
Walking
Ambulation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Paralysis
Paraplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations