Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:February 21, 2017
End Date:January 17, 2018

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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).


Inclusion Criteria:

- 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

Exclusion Criteria:

- Failure to meet all inclusion criteria

- Pregnancy

- Colostomy bag

- Uncontrolled/untreated hyper- or hypotension
We found this trial at
7
sites
200 Belle Terre Road
Port Jefferson, New York 11777
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Port Jefferson, NY
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Atlanta, Georgia 30309
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Atlanta, GA
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345 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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Houston, Texas 77030
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Houston, TX
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Los Angeles, California 90048
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Los Angeles, CA
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8254 Atlee Road
Mechanicsville, Virginia 23116
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Mechanicsville, VA
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West Orange, New Jersey 07052
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from
West Orange, NJ
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