Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Parker Hannifin Corporation
- Enrollment
- 53
- Locations
- 9
- Primary Endpoint
- Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Indego
Indego
Intervention: Indego (Device)
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Walking Index for Spinal Cord Injury (WISCI-II) Assessment(8 weeks)
- Functional Independence Measure (FIM) Score for Walking Indoors(8 weeks)
- Borg Rating of Perceived Exertion (BRPE) for Walking Indoors(8 weeks)