Spinal Cord InjuryNCT03082898
Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Clinical Setting (SC140121 Study 1 and 2)
A study testing Indego Exoskeleton in people with Spinal Cord Injury, run by Vanderbilt University at 3 sites in United States.
Trial summary
The proposed study is intended to inform the hypotheses that (1) regular dosing of exoskeleton walking will provide health benefits to non-ambulatory and poorly-ambulatory individuals with SCI, including decreased pain and spasticity, improvements in bowel and bladder function, decreased body-mass index (BMI)… 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
- 41 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Nov 2016to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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).
- Non-ambulatory or poorly-ambulatory. In this study, "non-ambulatory" is defined as a person who cannot walk, or is classified with a Functional Independence Measure (FIM) Gait score 1; "poorly ambulatory" is 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 a appropriate stability aids, such as a rolling walker or forearm crutches, during exoskeleton walking.
- For Study 1 Present with SCI and NLI C5 or lower, with AIS A, B, C or D (as per the International Standard for Neurological Classification of SCI, ISNCSCI), who are non-ambulatory or poorly ambulatory.
- For Study 2: Present with SCI AIS classification A or B at neurological injury level (NLI) T4 or below, or with AIS classification C or D at neurological injury level C5 or below.
- 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: At rest: systolic 150 mmHg or less, diastolic 90 mmHg or less, heart rate 105 bpm or less. During exercise: systolic 180 mmHg or less, diastolic 105 mmHg or less, heart rate 145 bpm or less for Study 1.
- Ability to tolerate an upright standing position for 20 min, passive or active, without being lightheaded or having a headache.
- Sufficient responsiveness to FES in the quadriceps, hamstrings, tibialis anterior, and gastrocnemius, as defined by MMT in response to stimulation of 3 or greater on a 5-point MMT scale. Note that this is specifically for Study 2, but is included in Study 1 in order to economize study resources regarding enrollment, training, and assessment, as previously discussed.
- Access to a wireless internet connection. Note that is required only for Study 3, but is included in Study 1 in order to economize study resources regarding enrollment, training and assessment, as previously discussed.
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
Nashville, Tennessee, 37212
Mayo Clinic
Rochester, Minnesota, 55905
Tampa VA
Tampa, Florida, FL 33637-1022
About this study
The proposed study is intended to inform the hypotheses that (1) regular dosing of exoskeleton walking will provide health benefits to non-ambulatory and poorly-ambulatory individuals with SCI, including decreased pain and spasticity, improvements in bowel and bladder function, decreased body-mass index (BMI), enhanced well-being; (2) regular dosing of exoskeleton walking will facilitate neurological or functional recovery in some individuals with SCI, particularly those with incomplete injuries; and (3) the level of mobility enabled by a lower limb exoskeleton is commensurate with the walking speeds, distances, and surfaces required for community ambulation.
Read the detailed description
Study Outline Study 1, as described herein, will assess the three hypotheses, i.e., health benefit, neurological recovery, and mobility benefits, in the context of regular dosing of exoskeleton walking in a clinical setting. These studies will be conducted at three study sites, Vanderbilt University Medical Center in Nashville TN, the James A. Haley Veterans Hospital in Tampa FL, and the Mayo Clinic in Rochester MN. All study sites will conduct an identical study protocol. The study will involve 24 non-ambulatory and poorly-ambulatory individuals with incomplete and complete SCI (i.e., 8 subjects at each site). In this study, "poorly ambulatory" is defined as persons with functional independence measure (FIM) gait score of 2 to 6 who may be able to walk short distances with or without braces and 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. Of the 24 individuals, half will be individuals with motor-complete injuries (i.e., American Spinal Injury Association Injury Scale, AIS, A or B), and half with motor-incomplete injuries (i.e., AIS C or D). As described subsequently in the Study Procedures section, the study will assess the therapeutic and functional effects of exoskeleton walking over an 8-week period of treatment, where the treatment consists of 3 walking sessions per week, each approximately 1.5 hours in duration for a total of 24 walking sessions. Therapeutic effects will be assessed via a number of measurements recorded primarily at study start, at the 4-week study midpoint, at the 8-week completion of treatment, and in a follow-up session, 8 weeks following the conclusion of treatment.
Study 2 will add 10 channels of functional electrical stimulation (FES )to the Indego exoskeleton , which include the quadriceps, hamstrings, gastrocnemius, and tibialis anterior muscle groups of each leg, in addition to a pair of trunk muscle channels. The nature of stimulation is fully consistent with standard-of-care FES units, although the timing and amplitude of the leg muscle stimulation is adjusted automatically by the exoskeleton, in a manner similar to the automated adjustment of stimulation in FES-aided cycling devices (also a standard intervention).
- Conditions
- Spinal Cord Injury
- 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 group | Role | What they receive |
|---|---|---|
| AIS A or B using Indego Exoskeleton | Experimental | Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking. Receives: Device: Indego Exoskeleton |
| AIS C or D using Indego Exoskeleton | Experimental | Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking. Receives: Device: Indego Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Required to Walk 10 Meters in Seconds as Measured by the Ten Meter Walk Test (10MWT)
Measure of mobility (specifically gait speed) while wearing exoskeleton
Measured: Session 11 (Week 5), Session 16 (Week 6), Session 24 (Week 9), and Session 29 (Week 11)
The Total Distance Walked by the Patient in 6 Minutes as Measured by the Six-Minute Walk Test (6MWT)
Measure of gait speed over six minutes while wearing exoskeleton
Measured: Session 16 (Week 6) and Session 29 (Week 11)
Secondary outcomes (1)
Time Required to Independently Sit, Stand, Walk, Turn, and Return to Sitting as Measured by the Timed Up and Go (TUG) Test
Measure of ability to stand, walk, turn, and sit while wearing exoskeleton
Measured: Session 15 (Week 6), and Session 28 (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start15 Nov 2016
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Goldfarb, Vanderbilt University
- Investigators
- Michael Goldfarb, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082898
- Sponsor's protocol ID
- SC140121
- Status last verified
- Jan 2022
- First submitted
- 22 Feb 2017
- Last updated
- 16 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Clinical Setting (SC140121 Study 1 and 2)
- ClinicalTrials.gov ID
- NCT03082898
- Acronym / sponsor ID
- SC140121
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Posted 16 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is intended to inform the hypotheses that (1) regular dosing of exoskeleton walking will provide health benefits to non-ambulatory and poorly-ambulatory individuals with SCI, including decreased pain and spasticity, improvements in bowel and bladder function, decreased body-mass index (BMI), enhanced well-being; (2) regular dosing of exoskeleton walking will facilitate neurological or functional recovery in some individuals with SCI, particularly those with incomplete injuries; and (3) the level of mobility enabled by a lower limb exoskeleton is commensurate with the walking speeds, distances, and surfaces required for community ambulation.
Detailed description
Study Outline Study 1, as described herein, will assess the three hypotheses, i.e., health benefit, neurological recovery, and mobility benefits, in the context of regular dosing of exoskeleton walking in a clinical setting. These studies will be conducted at three study sites, Vanderbilt University Medical Center in Nashville TN, the James A. Haley Veterans Hospital in Tampa FL, and the Mayo Clinic in Rochester MN. All study sites will conduct an identical study protocol. The study will involve 24 non-ambulatory and poorly-ambulatory individuals with incomplete and complete SCI (i.e., 8 subjects at each site). In this study, "poorly ambulatory" is defined as persons with functional independence measure (FIM) gait score of 2 to 6 who may be able to walk short distances with or without braces and 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. Of the 24 individuals, half will be individuals with motor-complete injuries (i.e., American Spinal Injury Association Injury Scale, AIS, A or B), and half with motor-incomplete injuries (i.e., AIS C or D). As described subsequently in the Study Procedures section, the study will assess the therapeutic and functional effects of exoskeleton walking over an 8-week period of treatment, where the treatment consists of 3 walking sessions per week, each approximately 1.5 hours in duration for a total of 24 walking sessions. Therapeutic effects will be assessed via a number of measurements recorded primarily at study start, at the 4-week study midpoint, at the 8-week completion of treatment, and in a follow-up session, 8 weeks following the conclusion of treatment.
Study 2 will add 10 channels of functional electrical stimulation (FES )to the Indego exoskeleton , which include the quadriceps, hamstrings, gastrocnemius, and tibialis anterior muscle groups of each leg, in addition to a pair of trunk muscle channels. The nature of stimulation is fully consistent with standard-of-care FES units, although the timing and amplitude of the leg muscle stimulation is adjusted automatically by the exoskeleton, in a manner similar to the automated adjustment of stimulation in FES-aided cycling devices (also a standard intervention).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIS A or B using Indego Exoskeleton | Experimental | Device: Indego ExoskeletonPatients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking. |
| AIS C or D using Indego Exoskeleton | Experimental | Device: Indego ExoskeletonPatients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indego ExoskeletonRegular dosing of Indego Exoskeleton walking. | Device | AIS A or B using Indego Exoskeleton, AIS C or D using Indego Exoskeleton |
Primary outcome
Time Required to Walk 10 Meters in Seconds as Measured by the Ten Meter Walk Test (10MWT)
Time frame: Session 11 (Week 5), Session 16 (Week 6), Session 24 (Week 9), and Session 29 (Week 11)
Measure of mobility (specifically gait speed) while wearing exoskeleton
The Total Distance Walked by the Patient in 6 Minutes as Measured by the Six-Minute Walk Test (6MWT)
Time frame: Session 16 (Week 6) and Session 29 (Week 11)
Measure of gait speed over six minutes while wearing exoskeleton
1 secondary outcome
Time Required to Independently Sit, Stand, Walk, Turn, and Return to Sitting as Measured by the Timed Up and Go (TUG) Test
Time frame: Session 15 (Week 6), and Session 28 (Week 10)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Goldfarb, MD principal investigator
Vanderbilt University
3 sites in 1 country: see every site and its status.
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: finished, as of the sponsor's last update on 16 Feb 2022. 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?
Yes. Results are posted in the registry (first posted 16 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time Required to Walk 10 Meters in Seconds as Measured by the Ten Meter Walk Test (10MWT) (time frame: Session 11 (Week 5), Session 16 (Week 6), Session 24 (Week 9), and Session 29 (Week 11)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2022.