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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
48
Six study sessions including five Indego training sessions over two weeks.
Cedars-Sinai Health System
Los Angeles, California, United States
Shepherd Center
Atlanta, Georgia, United States
Rehabilitation Institute of Chicago (Shirley Ryan AbilityLab)
Chicago, Illinois, United States
Kessler Foundation
West Orange, New Jersey, United States
Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events
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
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale
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
Time frame: 2 weeks
Activity Measured by Functional Ambulation Category
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
Time frame: 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St. Charles Hospital
Port Jefferson, New York, United States
TIRR Memorial Hermann
Houston, Texas, United States
Sheltering Arms Physical Rehabilitation Centers
Mechanicsville, Virginia, United States
Gait Speed (Without Indego) Measured With 10 Meter Walk Test
10 Meter Walk Test (MWT) without Indego to measure gait speed
Time frame: 2 weeks
Pain Measured With Face, Legs, Activity, Cry, Consolability Scale
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
Time frame: 2 weeks