Clinical trial NCT02202538: Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI).
Official title: Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: SCI
Indego
Walking
Lead sponsor: Parker Hannifin Corporation
Sponsor class: INDUSTRY
First posted: 2014-07-29
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 Acquired) 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.

Primary outcomes:
measure: Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)
timeFrame: 8 weeks
measure: Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study
timeFrame: 4 weeks, 8 weeks
measure: Timed Up and Go (TUG) Test
timeFrame: 8 weeks
measure: Average Time to Don/Doff Device
timeFrame: 8 weeks
measure: Percentage of Subjects That Could Don/Doff the Device Independently
timeFrame: 8 weeks
Secondary outcomes:
measure: Walking Index for Spinal Cord Injury (WISCI-II) Assessment
timeFrame: 8 weeks
measure: Functional Independence Measure (FIM) Score for Walking Indoors
timeFrame: 8 weeks
measure: Borg Rating of Perceived Exertion (BRPE) for Walking Indoors
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Chicago
country: United States
facility: Rehabilitation Institue of Chicago
state: Illinois
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
city: New York
country: United States
facility: RUSK Rehabilitation Center
state: New York
Study officials:
References: