Spinal Cord InjuriesNCT04047992
Seated Balance Using the Indego™
A study testing Indego™ Exoskeleton in people with Spinal Cord Injuries, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial summary
Exoskeleton-assisted walking (EAW) provides a new mobility option and appears to have potential therapeutic benefits for persons with SCI. However, present day technology is not sufficient to replace the wheelchair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Traumatic or non-traumatic SCI ≥6 months duration of SCI;
- Wheelchair-user for indoor and outdoor mobility;
- Level and completeness of injury T4 and below with complete or incomplete SCI (ISNCSCI A to D);
- Able to hold the crutches in hands with or without modifications; and
- Able to provide informed consent.
Who cannot join
- Diagnosis of neurological injury other than SCI;
- Progressive condition that would be expected to result in changing neurological status;
- Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;
- Anthropocentric incompatibility to be fitted with the device;
- Traumatic or high impact lower extremity fracture within the past 2 years;
- Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury;
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- Knee BMD < 0.60 gm/cm2;
- Total hip BMD T-scores < -3.5;
- Untreatable severe spasticity judged to be contraindicated by the Site Physician;
- Flexion contracture that is incompatible with the device;
- Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion > 00);
- Fracture of the foot by x-ray and confirmed by CT;
- Untreated or uncontrolled hypertension (systolic blood pressure >140 mmHg; diastolic blood pressure >90 mmHg);
- Unresolved orthostatic hypotension (systolic blood pressure <90 mmHg; diastolic blood pressure <60 mmHg) as judged to be contraindicated by the Site Physician;
- Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;
- History of seizure;
- Use of medications that significantly lower seizure threshold, such as tricyclic antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;
- History of stroke, brain tumor, brain abscess, or multiple sclerosis;
- History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging);
- History of implanted brain/spine/nerve simulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator;
- Psychopathology documentation in the medical record or history that may conflict with study objectives; and/or
- Pregnancy or women who plan to become pregnant during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
James J. Peters VA Medical Center
The Bronx, New York, 10468
Steven Knezevic, MS, 718-584-9000 ext. 3130, Steven.Knezevic@va.gov
Pierre K Asselin, MS, 718-584-9000 ext. 3124, Pierre.Asselin@va.gov
About this study
Official title: "The Effects of Exoskeletal-Assisted Walking on Seated Balance Using the Indego™"
Exoskeleton-assisted walking (EAW) provides a new mobility option and appears to have potential therapeutic benefits for persons with SCI. However, present day technology is not sufficient to replace the wheelchair. During EAW, users stand upright, maintain static and dynamic balance by actively and passively stimulating trunk and lower limb muscles in a manner not challenged during wheelchair use. Preliminary results in our laboratory suggest that the indirect balance challenges and postural perturbations that result during EAW training transfer to better seated balance control, resulting in more independence during seated activities. The purpose of this pilot study is to determine the effects of EAW training on various measures of seated balance (primary outcomes) and body composition (secondary outcomes). Twenty people with SCI (T4 and below) who are wheelchair users for mobility and cannot walk independently will be recruited. The participants will receive 36 sessions of EAW training in 12 weeks. The outcomes will be evaluated pre (baseline) and post (24 and 36 sessions). If EAW devices can be demonstrated to help people with SCI have better seated balance, in addition to the other potential benefits that are being investigated elsewhere, then exoskeletons may have the possibility to be more readily accepted in the clinical, home environments, and by the insurance companies.
Read the detailed description
Introduction/Background: People with spinal cord injury (SCI) can lose partial to complete voluntary control of arm, trunk and leg muscles, resulting in an inability to sit with stability, stand and/or walk. Because of poor trunk control during sitting, it may be challenging to reach for objects, dress or transfer independently, and the risk of a fall from their wheelchair is increased. Exoskeleton-assisted walking (EAW) provides upright, over ground mobility and has been demonstrated to be beneficial to improve patient-reported quality of life and some health-related outcomes. However, present day exoskeletons are not ready to replace the wheelchair. Our preliminary findings suggest that while walking in an exoskeleton, people with SCI are challenged to maintain upright balance by using their trunk muscles in a way that is rarely done from a wheelchair. Stimulation of the trunk muscles from upright postural challenges during EAW appears to benefit overall seated trunk control.
Summary of Goals and Objectives: The purpose of this study is to determine whether EAW can improve the primary outcomes of: seated balance, seated activities of daily living, and trunk muscle use. Additional secondary outcomes for body composition will be studied. Twenty people with SCI (T4 and below) who are wheelchair users will be recruited to participate.
Impact: The investigators believe that EAW training will significantly improve seated balance to improve wheelchair safety, stability and quality of life, thus, empowering people with SCI who use a wheelchair to live more independently. If EAW is demonstrated to have a significant benefit on seated balance, then use of these devices in the clinical and home environments may be further justified.
- Conditions
- Spinal Cord Injuries
- 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
The Indego® is a powered exoskeleton that can be used as a mode of therapy in an institutional setting. Proper walking in this device requires the user to manipulate their center of gravity and balance by postural trunk excursions in order for the legs to take steps.
| Study group | Role | What they receive |
|---|---|---|
| Exoskeleton Users | Experimental | All participants will receive 36 sessions of supervised EAW training using Indego™ for 12 weeks (3 to 4 sessions per week, 4-6 hours per week). The goal is to complete all 36 sessions in 12 weeks, but allowing for a two-week carryover to accommodate schedule conflicts or missed sessions. Receives: Device: Indego™ Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seated Computerized Dynamic Posturography (sCDP)
Seated balance will be measured by assessment of the limits of stability (LOS) using computerized dynamic posturography (SMART EquiTest, Natus). The SMART EquiTest® system utilizes a dynamic force plate to quantify the vertical forces exerted through the participant's center of gravity as s/he sits on a cushioned block with back unsupported and arms crossed over the clavicles.
Measured: Change from baseline after 8 weeks and after 12 weeks.
Secondary outcomes (2)
Seated Activities of Daily Living (ADLs)
Participants' seated ADLs will be assessed by self-reported Spinal Cord Independence Measure (SCIM) and Spinal Cord Injury - Functional Index (SCI-FI, short forms). Participants' functional performance of ADLs will be assessed using the timed t-shirt dressing test by a study team member.
Measured: Change from baseline after 8 weeks and after 12 weeks.
Motor Evoked Potentials (MEPs)
Leg muscles will be used to assess neuroplastic changes between the motor cortex and descending neural pathways below incomplete spinal lesions.
Measured: Change from baseline after 8 weeks and after 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Feb 2018
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047992
- Sponsor's protocol ID
- SPU-17-029
- Status last verified
- May 2025
- First submitted
- 15 May 2018
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effects of Exoskeletal-Assisted Walking on Seated Balance Using the Indego™"
- ClinicalTrials.gov ID
- NCT04047992
- Acronym / sponsor ID
- SPU-17-029
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exoskeleton-assisted walking (EAW) provides a new mobility option and appears to have potential therapeutic benefits for persons with SCI. However, present day technology is not sufficient to replace the wheelchair. During EAW, users stand upright, maintain static and dynamic balance by actively and passively stimulating trunk and lower limb muscles in a manner not challenged during wheelchair use. Preliminary results in our laboratory suggest that the indirect balance challenges and postural perturbations that result during EAW training transfer to better seated balance control, resulting in more independence during seated activities. The purpose of this pilot study is to determine the effects of EAW training on various measures of seated balance (primary outcomes) and body composition (secondary outcomes). Twenty people with SCI (T4 and below) who are wheelchair users for mobility and cannot walk independently will be recruited. The participants will receive 36 sessions of EAW training in 12 weeks. The outcomes will be evaluated pre (baseline) and post (24 and 36 sessions). If EAW devices can be demonstrated to help people with SCI have better seated balance, in addition to the other potential benefits that are being investigated elsewhere, then exoskeletons may have the possibility to be more readily accepted in the clinical, home environments, and by the insurance companies.
Detailed description
Introduction/Background: People with spinal cord injury (SCI) can lose partial to complete voluntary control of arm, trunk and leg muscles, resulting in an inability to sit with stability, stand and/or walk. Because of poor trunk control during sitting, it may be challenging to reach for objects, dress or transfer independently, and the risk of a fall from their wheelchair is increased. Exoskeleton-assisted walking (EAW) provides upright, over ground mobility and has been demonstrated to be beneficial to improve patient-reported quality of life and some health-related outcomes. However, present day exoskeletons are not ready to replace the wheelchair. Our preliminary findings suggest that while walking in an exoskeleton, people with SCI are challenged to maintain upright balance by using their trunk muscles in a way that is rarely done from a wheelchair. Stimulation of the trunk muscles from upright postural challenges during EAW appears to benefit overall seated trunk control.
Summary of Goals and Objectives: The purpose of this study is to determine whether EAW can improve the primary outcomes of: seated balance, seated activities of daily living, and trunk muscle use. Additional secondary outcomes for body composition will be studied. Twenty people with SCI (T4 and below) who are wheelchair users will be recruited to participate.
Impact: The investigators believe that EAW training will significantly improve seated balance to improve wheelchair safety, stability and quality of life, thus, empowering people with SCI who use a wheelchair to live more independently. If EAW is demonstrated to have a significant benefit on seated balance, then use of these devices in the clinical and home environments may be further justified.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton Users | Experimental | Device: Indego™ ExoskeletonAll participants will receive 36 sessions of supervised EAW training using Indego™ for 12 weeks (3 to 4 sessions per week, 4-6 hours per week). The goal is to complete all 36 sessions in 12 weeks, but allowing for a two-week carryover to accommodate schedule conflicts or missed sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Traumatic or non-traumatic SCI ≥6 months duration of SCI;
- Wheelchair-user for indoor and outdoor mobility;
- Level and completeness of injury T4 and below with complete or incomplete SCI (ISNCSCI A to D);
- Able to hold the crutches in hands with or without modifications; and
- Able to provide informed consent.
Key exclusion criteria (22 listed)
- Diagnosis of neurological injury other than SCI;
- Progressive condition that would be expected to result in changing neurological status;
- Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;
- Anthropocentric incompatibility to be fitted with the device;
- Traumatic or high impact lower extremity fracture within the past 2 years;
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™ ExoskeletonThe Indego® is a powered exoskeleton that can be used as a mode of therapy in an institutional setting. Proper walking in this device requires the user to manipulate their center of gravity and balance by postural trunk excursions in order for the legs to take steps. | Device | Exoskeleton Users |
Primary outcome
Seated Computerized Dynamic Posturography (sCDP)
Time frame: Change from baseline after 8 weeks and after 12 weeks.
Seated balance will be measured by assessment of the limits of stability (LOS) using computerized dynamic posturography (SMART EquiTest, Natus). The SMART EquiTest® system utilizes a dynamic force plate to quantify the vertical forces exerted through the participant's center of gravity as s/he sits on a cushioned block with back unsupported and arms crossed over the clavicles.
2 secondary outcomes
Seated Activities of Daily Living (ADLs)
Time frame: Change from baseline after 8 weeks and after 12 weeks.
Motor Evoked Potentials (MEPs)
Time frame: Change from baseline after 8 weeks and after 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
James J. Peters VA Medical Center
The Bronx, United States
1 site 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 Injuries, run by James J. Peters Veterans Affairs Medical Center at 1 site 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 5 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seated Computerized Dynamic Posturography (sCDP) (time frame: Change from baseline after 8 weeks and after 12 weeks.). 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 14 May 2025; AzTrials last refreshed its copy on 29 Oct 2026.