Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

Study Overview
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Brief Summary
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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).

Official Title
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Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

Conditions
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Cerebrovascular Accident (CVA), Stroke, Hemiplegia

Intervention / Treatment
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* Device: Indego Exoskeleton


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Enrolled Subjects<br>All enrolled subjects will receive gait training with the Indego. | Device: Indego Exoskeleton<br>* Six study sessions including five Indego training sessions over two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 weeks | 
| Activity Measured by Functional Ambulation Category | Activity measured by Functional Ambulation Category (FAC) unable to ambulate/ambulates only in parallel bars/requires supervision or physical assistance from > 1 person 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 requires manual contact of one person during ambulation on level surfaces/manual contact is continuous or intermittent light touch to assist balance or coordination 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 ambulation is independent on level surfaces/requires supervision/physical assistance to negotiate stairs, inclines, or unlevel surfaces ambulation is independent on unlevel and level surfaces, stairs and inclines | 2 weeks | 
| Gait Speed (Without Indego) Measured With 10 Meter Walk Test | 10 Meter Walk Test (MWT) without Indego to measure gait speed | 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 occasional grimace or frown, withdrawn, disinterested frequent to constant frown, clenched jaw, quivering chin Legs 0: normal position or relaxed uneasy, restless, tense kicking, or legs drawn up Activity 0: lying quietly, normal position, moves easily squirming, shifting back and forth, tense arched, rigid, or jerking Cry 0: no cry (awake or asleep) moans or whimpers, occasional complaint crying steadily, screams or sobs, frequent complaints Consolability 0: content, relaxed reassured by occasional touching, hugging, or being talked to, distractable difficult to console or comfort Minimum score: 0 Maximum Score: 10 | 2 weeks |