Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

Parker Hannifin

Status

Completed

Conditions

Stroke

Cerebrovascular Accident (CVA)

Hemiplegia

Treatments

Device: Indego Exoskeleton

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03054064

PHIND_CVA01

Details and patient eligibility

About

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).

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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