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



Status:Recruiting
Conditions:Hospital, Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - 80
Updated:4/2/2016
Start Date:August 2014

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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.


Inclusion Criteria:

- 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.

- 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.

Exclusion Criteria:

- 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 Aquired) Brain Injury

- 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.
We found this trial at
5
sites
West Orange, New Jersey 07052
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from
West Orange, NJ
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Atlanta, Georgia 30309
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Atlanta, GA
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Chicago, Illinois 60611
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Chicago, IL
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Englewood, Colorado 80113
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Englewood, CO
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New York, New York 10016
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New York, NY
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