Clinical trial NCT03054064: Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA
Official title: Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident (CVA)
Stroke
Hemiplegia
Lead sponsor: Parker Hannifin Corporation
Sponsor class: INDUSTRY
Collaborators: name: Shepherd Center, Atlanta GA
name: Cedars-Sinai Medical Center
name: Sheltering Arms Physical Rehabilitation Hospitals
name: Shirley Ryan AbilityLab
name: Kessler Foundation
name: St. Charles Hospital
name: TIRR Memorial Hermann
name: Rusk Rehabilitation
First posted: 2017-02-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


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
* 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

Primary outcomes:
measure: Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events
timeFrame: 2 weeks
Secondary outcomes:
measure: Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale
timeFrame: 2 weeks
measure: Activity Measured by Functional Ambulation Category
timeFrame: 2 weeks
measure: Gait Speed (Without Indego) Measured With 10 Meter Walk Test
timeFrame: 2 weeks
measure: Pain Measured With Face, Legs, Activity, Cry, Consolability Scale
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Health System
state: California
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago (Shirley Ryan AbilityLab)
state: Illinois
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
city: Port Jefferson
country: United States
facility: St. Charles Hospital
state: New York
city: Houston
country: United States
facility: TIRR Memorial Hermann
state: Texas
city: Mechanicsville
country: United States
facility: Sheltering Arms Physical Rehabilitation Centers
state: Virginia
Study officials:
References: