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Spinal Cord InjuriesNCT04532723

Exoskeleton-Assisted Walking ExoAtlet II

A study testing ExoAtlet II in people with Spinal Cord Injuries, run by Craig Hospital.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injuries
What is being tested?
ExoAtlet II
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2021to Oct 2023
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • ---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).

About this study

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.

Being tested
ExoAtlet II
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExoAtlet IIDevice

    ExoAtlet II is the second version of an exoskeleton that ExoAtlet has manufactured

Study groups in NCT04532723
Study groupRoleWhat they receive
ExoAtlet IIExperimentalSafety/feasibility of utilizing the ExoAtlet II in a clinical setting with a group of individuals with SCI
Receives: Device: ExoAtlet II

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Skin Integrity

    Skin breakdown

    Measured: change from baseline skin integrity at 2 weeks

  2. Change in Falls

    Number of falls

    Measured: change from baseline number of falls at 2 weeks

  3. Change in Fractures

    Number of fractures and cause

    Measured: change from baseline number of fractures at 2 weeks

Secondary outcomes (11)

  1. Heart Rate

    Heart rate beats per minute

    Measured: Baseline, Week 1

  2. Blood pressure

    Blood pressures mm/Hg

    Measured: Baseline, Week 1

  3. Spasticity

    Modified Ashworth

    Measured: Baseline, Week 1, Week 2

  4. Standing Time

    Upright and weight bearing total time

    Measured: Baseline, Week 1

  5. Ambulation Time

    Total walking time

    Measured: Week 1

  6. Standing Assistance

    level of assistance in standing

    Measured: Baseline, Week 1

  7. Ambulation Assistance

    Level of assistance for walking

    Measured: Week 1

  8. 6 Minute Walk Test

    Total distance walked in 6 minutes

    Measured: Week 1

  9. 10 Meter Walk Test

    total time to walk 10 meters

    Measured: Week 1

  10. 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

    Measured: Baseline, Week 1, Week 2

  11. 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

    Measured: Baseline, Week 1

Timeline

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

  1. First posted31 Aug 2020
  2. Study startJun 2021 (estimated)
  3. Primary completionJul 2023 (estimated)
  4. Study completionOct 2023 (estimated)

Why it stopped: Company lost funding

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04532723
Sponsor's protocol ID
IRBNet ID 1559813
Status last verified
Aug 2021
First submitted
15 Jul 2020
Last updated
26 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing ExoAtlet II in people with Spinal Cord Injuries, run by Craig Hospital.

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 12 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: withdrawn, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Change in Skin Integrity (time frame: change from baseline skin integrity at 2 weeks). The study lists 3 primary outcomes in all. 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 NCT04532723.

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 Aug 2021; AzTrials last refreshed its copy on 31 Oct 2026.

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