Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Home and Community Setting (SC140121 Study 3)

November 5, 2020 updated by: Michael Goldfarb, Vanderbilt University
The proposed study is a pilot study intended to inform the hypothesis that regular walking in an exoskeleton within the home and community might offer health benefit, neurological recovery, and/or mobility benefit to the user. This exploratory pilot study is also intended to assess the level of compliance (i.e., exoskeleton use) among study participants by characterizing extent the device is used beyond the minimum required.

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Withdrawn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.

Detailed Description

Study 3 Outline Study 3 enrollment will be limited to 1 or 2 subjects at each site. Each subject will take home an exoskeleton for the 8-week duration of the treatment period. The subjects will be selected from the pool of poorly-ambulatory subjects previously enrolled in Studies 1 and/or 2, and as such will have prior experience walking in the exoskeleton. Note that study 3 will emply the exoskeleton as per existing FDA approval (510(k) number K171334); specifically, "to enable individuals with spinal cord injury at levels T3 to L5 to perform ambulatory functions [in the home and community] with supervision of a specially trained companion in accordance with the user assessment and training certification program." Use of the exoskeleton in the home and community (i.e., outside a clinical setting) is referred to as "personal use." So that this study complies with FDA approval for personal use, subjects selected for enrollment in Study 3, along with each subject's designated support person, will be trained and certified for personal use in accordance with the manufacturer's FDA-approved personal use training program.

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33637
        • Tampa VA
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Minnesota Mayo Clinic
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years or older.
  • Size and limb proportions capable of fitting in the exoskeletal device :
  • Height between 1.55 m (5 ft, 1 in) and 1.92 m (6 ft, 3 in).
  • Femur length between 37.5 cm (15 in) and 43.125 cm (17.25 in).
  • Body mass no greater than 114 kg (250 lb).
  • "Poorly ambulatory" individual, defined as a person with FIM Gait 2- 6, who may be able to walk short distances with or without braces or stability aid, or may be able to walk with assistance of one person, but whose primary means of mobility is a manual or power-operated wheelchair.
  • Sufficient upper extremity strength and coordination to balance using appropriate stability aids, such as a rolling walker or forearm crutches, during exoskeleton walking.
  • Neurological injury level (NLI) T3 to L5 (between and inclusive).
  • Chronic SCI: at least 6 months post-injury, and preferably post-injury more than 1 year.
  • Sufficient bone health for walking with full weight-bearing without undue risk of fracture, as determined by each subject's personal medical doctor, and approved by each site's medical supervisor.
  • 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.
  • Skin intact where interfacing with robotic device.
  • MAS for spasticity score 3 or less in lower extremities.
  • Resting blood pressure and heart rate within established guidelines for locomotor training, specifically systolic 150 mmHg or less, diastolic 90 mmHg or less, heart rate 105 bpm or less.
  • Ability to tolerate an upright standing position for 20 min, passive or active, without being lightheaded or having a headache.
  • Availability and willingness of support person to be trained in accordance with the FDA training protocol for personal use of the exoskeleton, and who will assume responsibility for the support person role, which specifically includes providing ambulatory support during all exoskeletal walking.
  • Access to a wireless internet connection (for use of exoskeleton iPod device).
  • Willingness and ability to electronically send walking session reports from exoskeleton iPod to appointed site monitor following each walking session.

Exclusion Criteria:

  • Heterotopic ossification that, in the opinion of the site medical supervisor, would place the subject at undue risk for fracture.
  • Inability to follow instructions.
  • Colostomy bag.
  • Women who are pregnant or attempting to become pregnant during the course of the study. Note that a pregnancy test will be required and must be negative for all women prior to enrolling in the study, and will be additionally required and must be negative every four weeks during the course of the study protocol.
  • Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol- specified assessments.
  • Insufficient availability to complete study.
  • Any other issue which, in the opinion of the investigators or medical supervisor, make the subject unsuitable for study participation.

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: HEALTH_SERVICES_RESEARCH
  • 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.
OTHER: Interventional
Walking in an exoskeleton within the home and community.
Device: Indego Exoskeleton
Regular dosing of Indego Exoskeleton walking.

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
Ten meter walk test (10MWT)
Time Frame: 18 weeks
Measure of mobility (specifically gait speed) while wearing exoskeleton. Scale 1 to 7 (1=total assistance and 7=independent)
18 weeks
Six minute walk test (6MWT)
Time Frame: 18 weeks
Measure of gait speed over six minutes while wearing exoskeleton. Scale 1 to 7 (1=total assistance and 7=independent)
18 weeks
Walking Index for Spinal Cord Injury II (WISCI-II)
Time Frame: 18 weeks
Assessment of physical assistance required during walking while wearing exoskeleton. Scale 0 to 20 (0= unable to participate and 20 Ambulates with no devices, no braces and no physical assistance.
18 weeks
Functional Independence Measures (FIM) gait score
Time Frame: 18 weeks
Assessment of physical assistance required during walking while wearing exoskeleton. Scale 0 to 7 (0= activity does not occur and 7= complete independence
18 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
Timed Up and Go Test (TUG)
Time Frame: 18 weeks
Measure of ability to stand, walk, turn, and sit while wearing exoskeleton. ≤ to 10 seconds to > 30 seconds (≤ 10 seconds=normal to > 30 predictive of requiring assistive device for ambulation and being dependent in ADLs
18 weeks
Borg Rating Scale of Perceived Exertion (RPE)
Time Frame: 18 weeks
Measure of exertion required while using exoskeleton. Scale 6 to 20 (6= no exertion and 20 = maximal exertion
18 weeks
Modified Ashworth Score (MAS)
Time Frame: 18 weeks
Measure of bone mineral density. Scale 0 to 4 (0=No increase in muscle tone and 4=Affected part(s) rigid in flexion or extension)
18 weeks
Bone Mineral Density
Time Frame: 18 weeks
Measure of bone mineral density. Score -1 and above to -2.5 and below (-1.0 to +0.5= normal and -2.5 and below=osteoporosis)
18 weeks
Functional Reach
Time Frame: 18 weeks
Measure of core strength. 0 to 3 (0= unable to reach 3=Reach > or = to 10 inches)
18 weeks
Manual Muscle Test (MMT)
Time Frame: 18 weeks
Measure of muscle strength Scale 0 to 5 (0= No visible or palpable contraction and 5=Full ROM against gravity, maximul resistance
18 weeks
Ten Meter Walk Test without exoskeleton (10MWT)
Time Frame: 18 weeks
Measure of walking speed without exoskeleton. Measure of mobility (specifically gait speed) while wearing exoskeleton. Scale 1 to 7 (1=total assistance and 7=independent)
18 weeks
Functional Independence Measures (FIM) gait score without exoskeleton
Time Frame: 18 weeks
Measure of assistance required for walking without exoskeleton Scale 0 to 7 (0= activity does not occur and 7= complete independence
18 weeks
Walking Index for Spinal Cord Injury II (WISCI-II) score without exoskeleton
Time Frame: 18 weeks
Measure of assistance required for walking without exoskeleton. Scale 0 to 20 (0= unable to participate and 20 Ambulates with no devices, no braces and no physical assistance.
18 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET)
Time Frame: 18 weeks
Survey of severity of spasticity. Score -3 to +3 ( -3 (extremely problematic) to +3 (extremely helpful).
18 weeks
Self-Report Survey
Time Frame: 18 weeks
Survey of pain, spasticity, bowel and bladder function, and quality of life. Pain 0 to 5 (0=no pain and 5 =severe pain. Overall level of pain -3 to 3 (-3 =decreased and 3 =increased) Spasticity 0 to 5 (0= No spasticity and 5 Severe spasticity) Overall level of spasticity -3 to 3 (-3 =decreased and 3 =increased) Changes in bowel habits -3 to 3 (-3 worse and 3=better) Changes in bladder habits -3 to 3 (-3 worse and 3=better) Changes in mood -3 to 3 (-3 worse and 3=better)
18 weeks
American Spinal Injury Association (ASIA) Impairment Scale
Time Frame: 18 weeks
Measure of neurological injury level and classification. Scale A to E (A= complete and E= normal)
18 weeks

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.
Vanderbilt University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Goldfarb, PhD, Vanderbilt University

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.
May 1, 2020

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.
June 30, 2020

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.
December 31, 2020

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).
October 8, 2019

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.
October 31, 2019

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.
November 4, 2019

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.
November 9, 2020

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.
November 5, 2020

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.
November 1, 2020

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.
  • SC140121 Study 3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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