Spinal Cord InjuryIndegoNCT02202538

Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI).

A study testing Indego in people with Spinal Cord Injury, run by Parker Hannifin Corporation at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the Indego® device for safety and effectiveness at allowing persons with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Spinal Cord Injury
What is being tested?: Indego
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 5 sitesUnited States
Study dates: Aug 2014to Oct 2015
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be 18 years or older
Height 5'1" to 6'3" (Acceptable height may vary by a few inches depending on femur length).
Hip width as measured in sitting no greater than 16.6" (42 cm) (acceptable hip width may vary depending on soft tissue).
Femur length as measured in sitting must be between 14 inches (35.5cm) and 18.5 inches (47 cm)
Weight 250lbs (113.4 kg) or less
Present with Spinal Cord Injury and NLI C5 and lower, with ISNCSCI A, B, C or D who are non-ambulatory or poorly ambulatory.

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There are no restrictions on time since injury. However, each subject must have signed medical clearance/approval for full weight bearing and locomotor training.
Determined to have sufficient bone health for walking with full weight bearing without undue risk for fracture. Meeting of this criterion is at the discretion of each subject's personal MD and must be approved by each site's Medical PI.
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 must be intact where it interfaces with robotic device
Modified Ashworth Scale for spasticity score must be 3 or less.
Blood pressure and heart rate within established guidelines for locomotor training:
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
Tolerate being in an upright standing position (passive or active) without being lightheaded or having a headache.

Who cannot join

Weight in excess of 250 lbs
Heterotopic ossification that, in the opinion of the investigator, would place the subject at undue risk for fracture.
Any subject deemed at increased risk for injury by Medical Personnel
Lower extremity joint limitation that exceeds 10 degrees at their hips, knees or ankles.
Light headedness or headache in standing position (active or passive)
Moderate to Severe Traumatic (or Acquired) Brain Injury

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Inability to follow instructions
Colostomy bag
Women who are pregnant or attempting to become pregnant during the study intervention.
Unable to obtain informed consent (either from the subject or from the subjects Legally Authorized Representative).
Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol specified assessments
Unlikely to be available for follow-up phone call.
Any other issue which, in the opinion of the investigators, will make the subject unsuitable for study participation.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Shepherd Center
Atlanta, Georgia, 30309
Rehabilitation Institue of Chicago
Chicago, Illinois, 60611
Craig Hospital
Englewood, Colorado, 80113
RUSK Rehabilitation Center
New York, New York, 10016
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052

Other trials in United States

About this study

This study will evaluate the Indego® device for safety and effectiveness at allowing persons with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.

Conditions: Spinal Cord Injury
Being tested: Indego
Keywords: SCI, Indego, Walking
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.

IndegoDevice
Indego

Study groups in NCT02202538
Study group	Role	What they receive
Indego	Experimental	Indego Receives: Device: Indego

What is being measured

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

Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)
Measured time for an individual to complete walking 600 meters on a level surface with the Indego and stability aid at the end of the study, proposed to be representative of an individual's ability to ambulate in the community.
Measured: 8 weeks
Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study
Measured time for an individual to complete walking 10 meters with the Indego and a stability aid midway through the study and at the end of the study.
Measured: 4 weeks, 8 weeks
Timed Up and Go (TUG) Test
Measures the time required for an individual to stand from a seated position, walk three meters, turn, walk back three meters, turn and return to a seated position.
Measured: 8 weeks
Average Time to Don/Doff Device
Time needed for an individual to don or doff the device.
Measured: 8 weeks
Percentage of Subjects That Could Don/Doff the Device Independently
The percentage of participants that could don/doff the device independently at the end of the study, without the help of their Physical Therapist.
Measured: 8 weeks

Secondary outcomes (3)

Walking Index for Spinal Cord Injury (WISCI-II) Assessment
Assesses physical assistance and devices required for persons to walk following paralysis resulting from a Spinal Cord Injury.
0:unable
1. parallel bars, braces, help of 2 persons,<10m
2. parallel bars, braces, help of 2 persons,10m
3. parallel bars, braces, help of 1 person,10m
4. parallel bars, no braces, help of 1 person,10m
5. parallel bars, braces, no help,10m
6. walker, braces, help of 1 person,10m 7:2 crutches, braces, help of 1 person,10m
8:walker, no braces, help of 1 person,10m 9:walker, braces, no help,10m 10:1 cane/crutch, braces, help of 1 person,10m 11:2 crutches, no braces, help of 1 person,10m 12:2 crutches, braces, no help,10m 13:walker, no braces/help,10m 14:1 cane/crutch, no braces, help of 1 person,10m 15:1 cane/crutch, braces, no help,10m 16:2 crutches, no braces/help,10m 17:no devices/braces, help of 1 person,10m 18: no devices, braces, no help,10m 19:1cane/crutch, no braces/help,10m 20:no devices/braces/help,10m
Reference: rehabmeasures.org
Measured: 8 weeks
Functional Independence Measure (FIM) Score for Walking Indoors
FIM measures an individual's level of disability and indicates how much assistance is needed for that individual to carry out activities of daily living.
7: complete independence 6: modified independence 5: supervision or setup assistance 4: minimal contact assistance 3: moderate assistance 2: maximal assistance
1: total assistance
Reference: rehabmeasures.org
Measured: 8 weeks
Borg Rating of Perceived Exertion (BRPE) for Walking Indoors
The BPRE characterizes the level of effort required by an individual to perform a task and takes into account both the person's fitness level and the difficulty of the task.
6: no exertion at all 7: extremely light 8-9: very light 10-11: light 12-13: somewhat hard 14-15: hard (heavy) 16-17: very hard 18-19: extremely hard 20: maximal exertion
Measured: 8 weeks

Timeline

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

Aug 2014Oct 2015

First posted29 Jul 2014 (estimated)
Study startAug 2014
Primary completionOct 2015
Study completionOct 2015

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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02202538
Sponsor's protocol ID: PH-IND01
Acronym: Indego
Status last verified: Jun 2017
First submitted: 23 Jul 2014
Last updated: 25 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
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All Spinal Cord Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI).
ClinicalTrials.gov ID: NCT02202538
Acronym / sponsor ID: Indego / PH-IND01
Conditions: Spinal Cord Injury
Keywords: SCI, Indego, Walking
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Parker Hannifin CorporationIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 29 Jul 2014 (estimated)
Results: Posted 20 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the Indego® device for safety and effectiveness at allowing persons with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Indego	Experimental	Device: IndegoIndego

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Be 18 years or older
Height 5'1" to 6'3" (Acceptable height may vary by a few inches depending on femur length).
Hip width as measured in sitting no greater than 16.6" (42 cm) (acceptable hip width may vary depending on soft tissue).
Femur length as measured in sitting must be between 14 inches (35.5cm) and 18.5 inches (47 cm)
Weight 250lbs (113.4 kg) or less

Key exclusion criteria (13 listed)

Weight in excess of 250 lbs
Heterotopic ossification that, in the opinion of the investigator, would place the subject at undue risk for fracture.
Any subject deemed at increased risk for injury by Medical Personnel
Lower extremity joint limitation that exceeds 10 degrees at their hips, knees or ankles.
Light headedness or headache in standing position (active or passive)

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
IndegoIndego	Device	Indego

Primary outcome

Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)
Time frame: 8 weeks
Measured time for an individual to complete walking 600 meters on a level surface with the Indego and stability aid at the end of the study, proposed to be representative of an individual's ability to ambulate in the community.
Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study
Time frame: 4 weeks, 8 weeks
Measured time for an individual to complete walking 10 meters with the Indego and a stability aid midway through the study and at the end of the study.
Timed Up and Go (TUG) Test
Time frame: 8 weeks
Measures the time required for an individual to stand from a seated position, walk three meters, turn, walk back three meters, turn and return to a seated position.
Average Time to Don/Doff Device
Time frame: 8 weeks
Time needed for an individual to don or doff the device.
Percentage of Subjects That Could Don/Doff the Device Independently
Time frame: 8 weeks
The percentage of participants that could don/doff the device independently at the end of the study, without the help of their Physical Therapist.

3 secondary outcomes

Walking Index for Spinal Cord Injury (WISCI-II) Assessment
Time frame: 8 weeks
Functional Independence Measure (FIM) Score for Walking Indoors
Time frame: 8 weeks
Borg Rating of Perceived Exertion (BRPE) for Walking Indoors
Time frame: 8 weeks

Results and safety

Results posted to the registry on 20 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	53	45

Primary outcome: Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)

Time frame: 8 weeks. Number. Unit: percentage of participants

Measure	All Enrolled Subjects Who Completed the Study n = 45
Value	95.6

Primary outcome: Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study

Time frame: 4 weeks, 8 weeks. Mean (Standard Deviation). Unit: meters/second

Measure	All Enrolled Subjects Who Completed the Study n = 45
Average speed for 10MWT mid study	0.31 (0.10)
Average speed for 10MWT end of study	0.37 (0.09)

Primary outcome: Timed Up and Go (TUG) Test

Time frame: 8 weeks. Mean (Standard Deviation). Unit: seconds

Measure	All Enrolled Subjects Who Completed the Study n = 45
Value	84.09 (20.41)

Primary outcome: Average Time to Don/Doff Device

Time frame: 8 weeks. Mean (Standard Deviation). Unit: minutes

Measure	All Enrolled Subjects Who Completed the Study n = 45
Average time to don device	9.3 (4.5)
Average time to doff device	2.6 (1.4)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	0 of 53 (0%)	19 of 53 (35.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Spinal Cord Injury

Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
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Recruiting
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Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
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Not yet recruiting
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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.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Indego in people with Spinal Cord Injury, run by Parker Hannifin Corporation at 5 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 15 inclusion and 13 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 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 20 Dec 2016). 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?

Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT) (time frame: 8 weeks). The study lists 5 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 NCT02202538.

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 25 Jul 2017.