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Exoskeleton-Assisted Walking ExoAtlet II

Primary Purpose

Spinal Cord Injuries

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ExoAtlet II
Sponsored by
Craig Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ExoAtlet II

    Arm Description

    Safety/feasibility of utilizing the ExoAtlet II in a clinical setting with a group of individuals with SCI

    Outcomes

    Primary Outcome Measures

    Change in Skin Integrity
    Skin breakdown
    Change in Falls
    Number of falls
    Change in Fractures
    Number of fractures and cause

    Secondary Outcome Measures

    Heart Rate
    Heart rate beats per minute
    Blood pressure
    Blood pressures mm/Hg
    Spasticity
    Modified Ashworth
    Standing Time
    Upright and weight bearing total time
    Ambulation Time
    Total walking time
    Standing Assistance
    level of assistance in standing
    Ambulation Assistance
    Level of assistance for walking
    6 Minute Walk Test
    Total distance walked in 6 minutes
    10 Meter Walk Test
    total time to walk 10 meters
    Physical Activity Enjoyment Scale
    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
    BORG Rate of Perceived Exertion
    Scale of participant effort. Lowest score is 6 and 20 is highest score. Higher scores reflect greater effort exerted by participant

    Full Information

    First Posted
    July 15, 2020
    Last Updated
    August 20, 2021
    Sponsor
    Craig Hospital
    Collaborators
    ExoAtlet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04532723
    Brief Title
    Exoskeleton-Assisted Walking ExoAtlet II
    Official Title
    Exoskeleton-Assisted Walking ExoAtlet II
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Company lost funding
    Study Start Date
    June 2021 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    October 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Craig Hospital
    Collaborators
    ExoAtlet

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ExoAtlet II
    Arm Type
    Experimental
    Arm Description
    Safety/feasibility of utilizing the ExoAtlet II in a clinical setting with a group of individuals with SCI
    Intervention Type
    Device
    Intervention Name(s)
    ExoAtlet II
    Intervention Description
    ExoAtlet II is the second version of an exoskeleton that ExoAtlet has manufactured
    Primary Outcome Measure Information:
    Title
    Change in Skin Integrity
    Description
    Skin breakdown
    Time Frame
    change from baseline skin integrity at 2 weeks
    Title
    Change in Falls
    Description
    Number of falls
    Time Frame
    change from baseline number of falls at 2 weeks
    Title
    Change in Fractures
    Description
    Number of fractures and cause
    Time Frame
    change from baseline number of fractures at 2 weeks
    Secondary Outcome Measure Information:
    Title
    Heart Rate
    Description
    Heart rate beats per minute
    Time Frame
    Baseline, Week 1
    Title
    Blood pressure
    Description
    Blood pressures mm/Hg
    Time Frame
    Baseline, Week 1
    Title
    Spasticity
    Description
    Modified Ashworth
    Time Frame
    Baseline, Week 1, Week 2
    Title
    Standing Time
    Description
    Upright and weight bearing total time
    Time Frame
    Baseline, Week 1
    Title
    Ambulation Time
    Description
    Total walking time
    Time Frame
    Week 1
    Title
    Standing Assistance
    Description
    level of assistance in standing
    Time Frame
    Baseline, Week 1
    Title
    Ambulation Assistance
    Description
    Level of assistance for walking
    Time Frame
    Week 1
    Title
    6 Minute Walk Test
    Description
    Total distance walked in 6 minutes
    Time Frame
    Week 1
    Title
    10 Meter Walk Test
    Description
    total time to walk 10 meters
    Time Frame
    Week 1
    Title
    Physical Activity Enjoyment Scale
    Description
    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
    Time Frame
    Baseline, Week 1, Week 2
    Title
    BORG Rate of Perceived Exertion
    Description
    Scale of participant effort. Lowest score is 6 and 20 is highest score. Higher scores reflect greater effort exerted by participant
    Time Frame
    Baseline, Week 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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).

    12. IPD Sharing Statement

    Learn more about this trial

    Exoskeleton-Assisted Walking ExoAtlet II

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