Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

Completed · Not applicable

Conditions studied: Cerebrovascular Accident (CVA), Stroke, Hemiplegia

In brief

The purpose of this study is to evaluate the safety and effectiveness of the Indego exoskeleton as a gait training tool for individuals with hemiplegia due to Cerebrovascular Accident (CVA).

Key facts

Study ID

NCT03054064

Run by

Parker Hannifin Corporation

People needed

48

Starts

2017-02-21

Expected to finish

2018-01-17

Last updated by the study team

2020-04-07

Who can join

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

You may qualify if…

• Height 5'1" to 6'3" (acceptable height may vary by a few inches depending on femur length)
• Weight 250 pounds or less
• History of one sided ischemic or hemorrhagic stroke with resultant hemiparesis
• Manual Muscle Test (MMT) 4/5 in at least upper extremity
• No restrictions on time since stroke (acuity), but all subjects need to be cleared by MD for locomotor training
• No other brain abnormalities or neurological diseases/disorders
• Has not been diagnosed with more than one stroke
• Passive range of motion (PROM) at shoulders, trunk, hips, knees and ankles within functional limits for safe gait
• Skin intact where interfaces with Indego device
• Modified Ashworth Scale (MAS) for spasticity 3 or less in the lower extremities
• Absence of complicating physical or mental conditions as determined by MD that would preclude the individual from safely participating in gait training
• Must be able to follow directions and communicate basic needs, demonstrated by a Mini- Mental State Exam (MMSE) score of 18 or greater

You may not qualify if…

• Failure to meet all inclusion criteria
• Pregnancy
• Colostomy bag
• Uncontrolled/untreated hyper- or hypotension

Where it is running

• Cedars-Sinai Health System — Los Angeles, California, United States
• Shepherd Center — Atlanta, Georgia, United States
• Rehabilitation Institute of Chicago (Shirley Ryan AbilityLab) — Chicago, Illinois, United States
• Kessler Foundation — West Orange, New Jersey, United States
• St. Charles Hospital — Port Jefferson, New York, United States
• TIRR Memorial Hermann — Houston, Texas, United States
• Sheltering Arms Physical Rehabilitation Centers — Mechanicsville, Virginia, United States

Full record on ClinicalTrials.gov

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