Non-Ambulatory SCI Walk Using a Robotic Exoskeleton: Effect on Bone and Muscle

Status unconfirmed · Not applicable

Conditions studied: Spinal Cord Injury

In brief

The purpose of this research study is to evaluate an exoskeleton device and mobility skills in the device.

Key facts

Study ID

NCT02324322

Run by

Kessler Foundation

People needed

13

Starts

2013-10-01

Expected to finish

2018-03-01

Last updated by the study team

2017-03-22

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be a non walker with a SCI greater than 1 year post injury
• Must have a neurological level between the C6-T10 level
• Must have a lower extremity score greater than 1 as defined by the neurological exam
• Must be between 21 and 45 years old
• Must be wheelchair reliant 100% of time
• Must have knee bone mineral density greater than .5755 gm/cm2 as determined by study staff
• Must have a score on the Modified Ashworth Scale equal to or less than 3 as determined by the study staff
• Must be able to tolerate upright standing for up to 30 minutes
• Must have joint range of motion within normal functional limits for ambulation
• Must have sufficient upper body strength to balance using the walker while wearing the exoskeleton
• Must have a height between 62 inches or 74 inches
• Must weigh less than 220 lbs,(limitation of the devices)
• Must have no joint tightening of any extremity that limits movement during walking with the assistive devices
• Must have no medical issue that precludes full weight bearing, ambulation or exercise intolerance in the exoskeleton (e.g. orthopedic injuries, pain, severe spasticity)
• Must have no skin issues (e.g. pressure sores) that would prevent wearing the device
• Must have no memory and/or thinking disability (e.g. due to brain injury)
• Must be able to follow directions well and demonstrate learning capability
• Must be able to physically fit into the exoskeletal device

You may not qualify if…

• A woman who is pregnant, lactating, or post-menopausal
• Wearing an external device that supports the spinal column or the head, neck, or trunk
• Have persistent orthostatic hypotension (blood pressure drop of more than 30 millimeters of Mercury in robotic system)
• Have had a hospitalization for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study or no presence of major cardiovascular or pulmonary disease, lower extremity deep vein thrombosis (within the last three months)
• Have been taking any medications known to influence bone metabolism

Where it is running

• Kessler Foundation — West Orange, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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