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Exoskeleton-Assisted Walking ExoAtlet II

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: NCT04532723
Recruitment Status : Withdrawn (Company lost funding)
First Posted : August 31, 2020
Last Update Posted : August 26, 2021
Sponsor:
Collaborator:
ExoAtlet
Information provided by (Responsible Party):
Candace Tefertiller, Craig Hospital

Study Description
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Brief Summary:
Based on prior exoskeleton research, it was determined that 40 participants of variable height, weight and injury level would provide a significant measure of the safety and feasibility of using the ExoAtlet II in individuals with SCI for standing and walking rehabilitation therapy. Craig Hospital will be responsible for enrolling up to 30 individuals during the study duration.The inclusion criteria will be utilized to identify appropriate subjects for this study.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: ExoAtlet II Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exoskeleton-Assisted Walking ExoAtlet II
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : October 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: ExoAtlet II
Safety/feasibility of utilizing the ExoAtlet II in a clinical setting with a group of individuals with SCI
 Device: ExoAtlet II
ExoAtlet II is the second version of an exoskeleton that ExoAtlet has manufactured


Outcome Measures
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Primary Outcome Measures :
  1. Change in Skin Integrity [ Time Frame: change from baseline skin integrity at 2 weeks ]
    Skin breakdown

  2. Change in Falls [ Time Frame: change from baseline number of falls at 2 weeks ]
    Number of falls

  3. Change in Fractures [ Time Frame: change from baseline number of fractures at 2 weeks ]
    Number of fractures and cause


Secondary Outcome Measures :
  1. Heart Rate [ Time Frame: Baseline, Week 1 ]
    Heart rate beats per minute

  2. Blood pressure [ Time Frame: Baseline, Week 1 ]
    Blood pressures mm/Hg

  3. Spasticity [ Time Frame: Baseline, Week 1, Week 2 ]
    Modified Ashworth

  4. Standing Time [ Time Frame: Baseline, Week 1 ]
    Upright and weight bearing total time

  5. Ambulation Time [ Time Frame: Week 1 ]
    Total walking time

  6. Standing Assistance [ Time Frame: Baseline, Week 1 ]
    level of assistance in standing

  7. Ambulation Assistance [ Time Frame: Week 1 ]
    Level of assistance for walking

  8. 6 Minute Walk Test [ Time Frame: Week 1 ]
    Total distance walked in 6 minutes

  9. 10 Meter Walk Test [ Time Frame: Week 1 ]
    total time to walk 10 meters

  10. Physical Activity Enjoyment Scale [ Time Frame: Baseline, Week 1, Week 2 ]
    Scale of participant enjoyment in the moment. 7-point bipolar rating scale, eleven items are reverse scored. Higher total score reflect greater levels of enjoyment

  11. BORG Rate of Perceived Exertion [ Time Frame: Baseline, Week 1 ]
    Scale of participant effort. Lowest score is 6 and 20 is highest score. Higher scores reflect greater effort exerted by participant


Eligibility Criteria
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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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Spinal Cord injury with lower extremity paralysis (partial or complete) levels T4-L5 (AIS A-C) or C7-T3 (AIS D)
  • 18 Years of age or older in general good health
  • Weight, no more than 220lbs (100kg)
  • Intact Skin
  • Able to stand without exhibiting symptomatic hypotension
  • Use a wheelchair for mobility at least 50% of the day
  • Enough strength in hands and shoulders to support standing and walking using crutches or a walker

  • Medical clearance for full weight-bearing

    ---Per our clinical guidelines, we will require all individuals with SCI who are going to use an exoskeleton to receive full weight-bearing medical clearance from their physician prior to participation. If they are unable to obtain full weight-bearing medical clearance they will not be able to participate in this study.

  • Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid
  • Hip width no greater than 18" (46 cm) measured when sitting
  • Femur length between 37 cm and 49 cm measured between mid-patellar tendon and the floor

Exclusion Criteria:

  • Spinal cord injury level higher than T4 (AIS A-C) or C7 ASIA D
  • Severe muscle stiffness/tightness
  • Significant spasticity (Modified Ashworth Scale score of 3 or above)
  • Trunk or lower extremity pressure wound
  • Unstable spine, un-healed limbs, or fractures

  • Presence of bone in soft tissue where bone normally does not exist (heterotopic ossification), limiting range of motion in the hip or knee joints

    ---Each individual who is interested in participating in this study will be screened for heterotropic ossification (HO) using a verbal checklist first and then they participate in a thorough range of motion (ROM) evaluation before being fit in the exoskeleton. If they verbalize a history of HO or demonstrate a bony block/resistance to passive ROM, they will be sent back to their physician to rule out HO and will not participate in the study until they receive additional clearance.

  • Joint instability, dislocation, moderate to severe hip dysplasia
  • Uncontrolled seizures
  • Fracture or lower-limb surgery in past year
  • Psychopathology, or other condition that the physician or investigator, in his or her clinical judgment, considers to be exclusionary to safely use an exoskeleton
  • Pregnant or lactating females (Potential female participants will be informed that risks to pregnant or lactating females are unknown; then they will be asked if they are pregnant or lactating, or if they could be pregnant. If there is any uncertainty, they will not be included in the study).
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Candace Tefertiller, Executive Director of Research and Evaluation; PT,DPT,PhD,NCS, Craig Hospital
ClinicalTrials.gov Identifier: NCT04532723    
Other Study ID Numbers: IRBNet ID 1559813
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries