Spinal Cord InjuryNCT02793635
Indego Exoskeleton After SCI
A study testing Indego Powered Exoskeleton in people with Spinal Cord Injury, run by Parker Hannifin Corporation at 3 sites in United States.
Trial summary
The purpose of this study is to assess the use of Indego as a gait training tool for subjects with complete or incomplete paraplegia as a result of spinal cord injury (SCI) who have preserved lower extremity function. 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 Powered Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2016to Mar 2018
- 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
- 18 years or older
- Height 5'1" to 6'3" (Acceptable height may vary by a few inches depending on femur length)
- Weight 250 lbs or less
- Present with paraplegia resulting from a complete or incomplete (AIS A, B, C, or D) Spinal Cord Injury (>1 year post-injury), with preserved LE function
- Uses wheelchair as primary means of mobility in the community
- Able to ambulate 14 meters with assist of 2 people and no orthostasis. Subjects may use any combination of stability aids and/or bracing.
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- Medical clearance for weight bearing and locomotor training
- Bone density exams will be at the discretion of each sites' Principle Investigator
- Passive range of motion (PROM) at shoulders, trunk, hips, knees and ankles within functional limits for safe gait and use of appropriate assistive device/stability aid
- Skin intact where interfaces with the Indego device
- Modified Ashworth Scale 3 or less in bilateral LEs
- Blood pressure and heart rate within Locomotor Training Guidelines
- At rest: Systolic 150 or less Diastolic 90 or less and Heart rate 105 or less
- Exercise: Systolic 180 or less Diastolic 105 or less and Heart Rate 145 or less
Who cannot join
- Inability to meet ALL inclusion criteria
- Currently participating in physical therapy for gait training
- Joint contractures of the shoulders, trunk, hips knees or ankles deemed unsafe for locomotor training by PT and or MD
- Edema that would put skin at risk for breakdown
- Modified Ashworth Spasticity of 4
- Inability to achieve adequate fit of the Indego device
- Pregnancy
- Colostomy bag
Trial locations and contacts
3 sites in 1 country.
United States3 sites
TIRR Memorial Hermann
Houston, Texas, - TIRR Memorial Hermann,
Sheltering Arms
Mechanicsville, Virginia, 23116
St. Charles Hospital
Port Jefferson, New York
About this study
Official title: Impact of Gait Training With an Exoskeleton on Walking Function After Spinal Cord Injury (SCI)
The purpose of this study is to assess the use of Indego as a gait training tool for subjects with complete or incomplete paraplegia as a result of spinal cord injury (SCI) who have preserved lower extremity function. It is hypothesized that subjects with complete or incomplete paraplegia who have preserved their lower extremity function will experience functional improvements after gait training with the Indego exoskeleton.
Subjects will complete a total of fifteen (15) sessions which include a combination of the following; Physical Therapy Evaluation, Indego Training, Mid-Way Assessment, and Post-Assessment.
The aim of this study is to measure the impact of gait training with the Indego device on body structure, function, and participation. Additionally it will assess the perceptions of physical therapists and subjects with SCI on the effectiveness of gait training with the Indego exoskeleton in subjects with preserved limited function.
- Conditions
- Spinal Cord Injury
- Being tested
- Indego Powered Exoskeleton
- Keywords
- Paraplegia, Gait, Exoskeleton
- Medical subject headings
- Spinal Cord Injuries, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indego Powered ExoskeletonDevice
Also called Vanderbilt exoskeleton
Subjects who have Spinal Cord Injury will wear the Indego device which will include being trained and evaluated for fifteen (15) sessions.
| Study group | Role | What they receive |
|---|---|---|
| SCI Patients | Experimental | * 10 subjects with complete or incomplete SCI (> 1 year post-injury) with preserved LE function will be recruited.
* No control group Receives: Device: Indego Powered Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional ambulation category (FAC) to measure gait quality
Categorizes patients according to basic motor skills necessary for functional ambulation
Measured: 1 Day
10 Meter Walking Test to measure fast gait speed
Assesses walking speed in meters per second over a short duration
Measured: 1 Day
6 Minute Walking test to measure endurance
Measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
Measured: 6 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker Hannifin Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793635
- Sponsor's protocol ID
- 15-01399
- Status last verified
- Aug 2018
- First submitted
- 24 May 2016
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gait Training With an Exoskeleton on Walking Function After Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT02793635
- Acronym / sponsor ID
- 15-01399
- Conditions
- Spinal Cord Injury
- Keywords
- Paraplegia, Gait, Exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Parker Hannifin CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 8 Jun 2016 (estimated)
- 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.
The purpose of this study is to assess the use of Indego as a gait training tool for subjects with complete or incomplete paraplegia as a result of spinal cord injury (SCI) who have preserved lower extremity function. It is hypothesized that subjects with complete or incomplete paraplegia who have preserved their lower extremity function will experience functional improvements after gait training with the Indego exoskeleton.
Subjects will complete a total of fifteen (15) sessions which include a combination of the following; Physical Therapy Evaluation, Indego Training, Mid-Way Assessment, and Post-Assessment.
The aim of this study is to measure the impact of gait training with the Indego device on body structure, function, and participation. Additionally it will assess the perceptions of physical therapists and subjects with SCI on the effectiveness of gait training with the Indego exoskeleton in subjects with preserved limited function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCI Patients | Experimental | Device: Indego Powered Exoskeleton* 10 subjects with complete or incomplete SCI (> 1 year post-injury) with preserved LE function will be recruited. * No control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18 years or older
- Height 5'1" to 6'3" (Acceptable height may vary by a few inches depending on femur length)
- Weight 250 lbs or less
- Present with paraplegia resulting from a complete or incomplete (AIS A, B, C, or D) Spinal Cord Injury (>1 year post-injury), with preserved LE function
- Uses wheelchair as primary means of mobility in the community
Key exclusion criteria (8 listed)
- Inability to meet ALL inclusion criteria
- Currently participating in physical therapy for gait training
- Joint contractures of the shoulders, trunk, hips knees or ankles deemed unsafe for locomotor training by PT and or MD
- Edema that would put skin at risk for breakdown
- Modified Ashworth Spasticity of 4
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 Powered ExoskeletonAlso: Vanderbilt exoskeletonSubjects who have Spinal Cord Injury will wear the Indego device which will include being trained and evaluated for fifteen (15) sessions. | Device | SCI Patients |
Primary outcome
Functional ambulation category (FAC) to measure gait quality
Time frame: 1 Day
Categorizes patients according to basic motor skills necessary for functional ambulation
10 Meter Walking Test to measure fast gait speed
Time frame: 1 Day
Assesses walking speed in meters per second over a short duration
6 Minute Walking test to measure endurance
Time frame: 6 Minutes
Measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Powered Exoskeleton in people with Spinal Cord Injury, run by Parker Hannifin Corporation 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 14 inclusion and 8 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 31 Aug 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional ambulation category (FAC) to measure gait quality (time frame: 1 Day). The study lists 3 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 31 Aug 2018; AzTrials last refreshed its copy on 27 Oct 2026.