Exoskeleton-Assisted Walking ExoAtlet II

August 20, 2021 updated by: Candace Tefertiller, Craig Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Skin Integrity
Time Frame: change from baseline skin integrity at 2 weeks
Skin breakdown
change from baseline skin integrity at 2 weeks
Change in Falls
Time Frame: change from baseline number of falls at 2 weeks
Number of falls
change from baseline number of falls at 2 weeks
Change in Fractures
Time Frame: change from baseline number of fractures at 2 weeks
Number of fractures and cause
change from baseline number of fractures at 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: Baseline, Week 1
Heart rate beats per minute
Baseline, Week 1
Blood pressure
Time Frame: Baseline, Week 1
Blood pressures mm/Hg
Baseline, Week 1
Spasticity
Time Frame: Baseline, Week 1, Week 2
Modified Ashworth
Baseline, Week 1, Week 2
Standing Time
Time Frame: Baseline, Week 1
Upright and weight bearing total time
Baseline, Week 1
Ambulation Time
Time Frame: Week 1
Total walking time
Week 1
Standing Assistance
Time Frame: Baseline, Week 1
level of assistance in standing
Baseline, Week 1
Ambulation Assistance
Time Frame: Week 1
Level of assistance for walking
Week 1
6 Minute Walk Test
Time Frame: Week 1
Total distance walked in 6 minutes
Week 1
10 Meter Walk Test
Time Frame: Week 1
total time to walk 10 meters
Week 1
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
Baseline, Week 1, Week 2
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
Baseline, Week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Craig Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ExoAtlet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRBNet ID 1559813

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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