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Spinal Cord InjuryNCT04149769

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

A study testing Indego Exoskeleton in people with Spinal Cord Injury, run by Vanderbilt University at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injury
What is being tested?
Indego Exoskeleton
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
1 May 2020to 31 Dec 2020
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Minnesota Mayo Clinic

    Rochester, Minnesota, 55905

  • Tampa VA

    Tampa, Florida, 33637

Other trials in United States

About this study

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.

Read the 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.

Being tested
Indego Exoskeleton
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.

  • Indego ExoskeletonDevice

    Regular dosing of Indego Exoskeleton walking.

Study groups in NCT04149769
Study groupRoleWhat they receive
InterventionalOtherWalking in an exoskeleton within the home and community.
Receives: Device: Indego Exoskeleton

What is being measured

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

  1. Ten meter walk test (10MWT)

    Measure of mobility (specifically gait speed) while wearing exoskeleton. Scale 1 to 7 (1=total assistance and 7=independent)

    Measured: 18 weeks

  2. Six minute walk test (6MWT)

    Measure of gait speed over six minutes while wearing exoskeleton. Scale 1 to 7 (1=total assistance and 7=independent)

    Measured: 18 weeks

  3. Walking Index for Spinal Cord Injury II (WISCI-II)

    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.

    Measured: 18 weeks

  4. Functional Independence Measures (FIM) gait score

    Assessment of physical assistance required during walking while wearing exoskeleton. Scale 0 to 7 (0= activity does not occur and 7= complete independence

    Measured: 18 weeks

Secondary outcomes (9)

  1. Timed Up and Go Test (TUG)

    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

    Measured: 18 weeks

  2. Borg Rating Scale of Perceived Exertion (RPE)

    Measure of exertion required while using exoskeleton. Scale 6 to 20 (6= no exertion and 20 = maximal exertion

    Measured: 18 weeks

  3. Modified Ashworth Score (MAS)

    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)

    Measured: 18 weeks

  4. Bone Mineral Density

    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)

    Measured: 18 weeks

  5. Functional Reach

    Measure of core strength. 0 to 3 (0= unable to reach 3=Reach > or = to 10 inches)

    Measured: 18 weeks

  6. Manual Muscle Test (MMT)

    Measure of muscle strength Scale 0 to 5 (0= No visible or palpable contraction and 5=Full ROM against gravity, maximul resistance

    Measured: 18 weeks

  7. Ten Meter Walk Test without exoskeleton (10MWT)

    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)

    Measured: 18 weeks

  8. Functional Independence Measures (FIM) gait score without exoskeleton

    Measure of assistance required for walking without exoskeleton Scale 0 to 7 (0= activity does not occur and 7= complete independence

    Measured: 18 weeks

  9. Walking Index for Spinal Cord Injury II (WISCI-II) score without exoskeleton

    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.

    Measured: 18 weeks

Timeline

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

  1. First posted4 Nov 2019
  2. Study start1 May 2020 (estimated)
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Why it stopped: COVID

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Poorly-ambulatory subjects previously enrolled in Studies 1 and/or 2, and as such will have prior experience walking in the exoskeleton.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04149769
Sponsor's protocol ID
SC140121 Study 3
Status last verified
Nov 2020
First submitted
8 Oct 2019
Last updated
9 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Indego Exoskeleton in people with Spinal Cord Injury, run by Vanderbilt University at 3 sites in United States.

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 18 inclusion and 7 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 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Ten meter walk test (10MWT) (time frame: 18 weeks). The study lists 4 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 NCT04149769.

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 9 Nov 2020.

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