Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons

Completed · Not applicable

Conditions studied: Spinal Cord Injuries

In brief

The purpose of this study is to investigate whether robotic exoskeleton training can improve walking performance after SCI as compared to conventional physical therapy.

Key facts

Study ID

NCT03011099

Run by

The University of Texas Health Science Center, Houston

People needed

12

Starts

2014-01-01

Expected to finish

2016-03-01

Last updated by the study team

2018-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Motor Incomplete spinal cord injury, as classified by American Spinal Injury Association guidelines, above the lumbar level (T12 and above).
• Able to independently stand for two minutes with or without an assistive device and with or without orthoses distal to the knee.
• Male or non-pregnant woman
• ≥ 18-years of age
• At least 6 months after injury
• Height between 5'2" and 6'2" (150-188 cm)
• Weight ≤ 220 pounds (100 kg)
• Ability to perform informed consent

You may not qualify if…

• Presence of clinical signs of lower motor neuron injury
• History of severe neurologic injuries other than SCI (MS, CP, ALS, TBI, CVA, etc.)
• Severe comorbidities: active infections, heart, lung, or circulatory conditions, pressure ulcers.
• Documented severe osteoporosis affecting the hip and spine
• Severe spasticity in the lower extremities (Modified Ashworth ≥ 3) or uncontrolled clonus
• Unstable spine
• Unhealed limb or pelvic fractures
• Skin issues that would prevent wearing the device
• Range of motion restrictions that would prevent subject from achieving a normal, reciprocal gait pattern, or would restrict a subject from completing normal sit to stand or stand to sit transitions.
• Upper extremity strength deficits that limit ability to balance with a front rolling walker or crutches.
• Heterotopic ossification that resists functional range of motion in lower extremities
• Contractures (>15 degrees at the hips or >20 degrees at the knees)
• Psychiatric or cognitive comorbidities resulting in motor planning or impulsivity concerns
• Colostomy
• Have received any physical therapy intervention within 3 months prior to enrolment in the study
• Non-English speaking

Where it is running

• The University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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