Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

Not Applicable

Completed

Conditions: Hemiplegia
Cerebrovascular Accident (CVA)
Stroke

Interventions: Device: Indego Exoskeleton

Registration Number: NCT03054064

Lead Sponsor: Parker Hannifin Corporation

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Enrolled Subjects	Indego Exoskeleton	All enrolled subjects will receive gait training with the Indego.

Primary Outcome Measures

Name	Time	Method
Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events	2 weeks	Safety of individuals with hemiplegia due to CVA using the Indego measured through reported Subject Adverse Events and Serious Adverse Events

Secondary Outcome Measures

Name	Time	Method
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale	2 weeks	Spasticity measured with Modified Ashworth Scale (MAS) 0 - No increase in muscle tone 1 - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM) 2 - More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3 - Considerable increase in muscle tone, passive movement difficult 4 - Affected part(s) rigid in flexion or extension
Pain Measured With Face, Legs, Activity, Cry, Consolability Scale	2 weeks	Pain measured with Face, Legs, Activity, Cry, Consolability (FLACC) Scale Face 0: no particular expression or smile 1. occasional grimace or frown, withdrawn, disinterested 2. frequent to constant frown, clenched jaw, quivering chin Legs 0: normal position or relaxed 1. uneasy, restless, tense 2. kicking, or legs drawn up Activity 0: lying quietly, normal position, moves easily 1. squirming, shifting back and forth, tense 2. arched, rigid, or jerking Cry 0: no cry (awake or asleep) 1. moans or whimpers, occasional complaint 2. crying steadily, screams or sobs, frequent complaints Consolability 0: content, relaxed 1. reassured by occasional touching, hugging, or being talked to, distractable 2. difficult to console or comfort Minimum score: 0 Maximum Score: 10
Activity Measured by Functional Ambulation Category	2 weeks	Activity measured by Functional Ambulation Category (FAC) 1. unable to ambulate/ambulates only in parallel bars/requires supervision or physical assistance from \> 1 person 2. requires manual contact of one person during ambulation on level surfaces/manual contact is continuous and necessary to support body weight and/or to maintain balance or assist coordination 3. requires manual contact of one person during ambulation on level surfaces/manual contact is continuous or intermittent light touch to assist balance or coordination 4. ambulation occurs on level surfaces without manual contact of another person/requires stand-by guarding of one person because of poor judgment, questionable cardiac status, or the need for verbal cuing to complete the task 5. ambulation is independent on level surfaces/requires supervision/physical assistance to negotiate stairs, inclines, or unlevel surfaces 6. ambulation is independent on unlevel and level surfaces, stairs and inclines
Gait Speed (Without Indego) Measured With 10 Meter Walk Test	2 weeks	10 Meter Walk Test (MWT) without Indego to measure gait speed

Trial Locations

Locations (7): Cedars-Sinai Health System
🇺🇸
Los Angeles, California, United States
Kessler Foundation
🇺🇸
West Orange, New Jersey, United States
Rehabilitation Institute of Chicago (Shirley Ryan AbilityLab)
🇺🇸
Chicago, Illinois, United States
Shepherd Center
🇺🇸
Atlanta, Georgia, United States
TIRR Memorial Hermann
🇺🇸
Houston, Texas, United States
Sheltering Arms Physical Rehabilitation Centers
🇺🇸
Mechanicsville, Virginia, United States
St. Charles Hospital
🇺🇸
Port Jefferson, New York, United States