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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.
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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:
Tolerate being in an upright standing position (passive or active) without being lightheaded or having a headache.
Exclusion criteria
Primary purpose
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Interventional model
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53 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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