Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

Parker Hannifin Corporation7 sites in 1 country48 target enrollmentFebruary 21, 2017

ConditionsCerebrovascular Accident (CVA)Stroke Hemiplegia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cerebrovascular Accident (CVA)
Sponsor: Parker Hannifin Corporation
Enrollment: 48
Locations: 7
Primary Endpoint: Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

February 21, 2017

End Date

January 17, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Parker Hannifin Corporation

Responsible Party

Sponsor

Eligibility Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events

Time Frame: 2 weeks

Safety of individuals with hemiplegia due to CVA using the Indego measured through reported Subject Adverse Events and Serious Adverse Events

Secondary Outcomes

Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale(2 weeks)
Pain Measured With Face, Legs, Activity, Cry, Consolability Scale(2 weeks)
Activity Measured by Functional Ambulation Category(2 weeks)
Gait Speed (Without Indego) Measured With 10 Meter Walk Test(2 weeks)