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Completed

NCT Number: NCT03054064

Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

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).

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Key information

Conditions

Cerebrovascular Accident (CVA) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Health System, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indego Exoskeleton

Device

Six study sessions including five Indego training sessions over two weeks.

Primary outcomes

  1. 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

  1. Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale

    Time frame: 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

  2. Activity Measured by Functional Ambulation Category

    Time frame: 2 weeks

    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

  3. Gait Speed (Without Indego) Measured With 10 Meter Walk Test

    Time frame: 2 weeks

    10 Meter Walk Test (MWT) without Indego to measure gait speed

  4. Pain Measured With Face, Legs, Activity, Cry, Consolability Scale

    Time frame: 2 weeks

    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

Sponsors and collaborators

Lead sponsor

Parker Hannifin Corporation

Industry

Collaborators

  • Cedars-Sinai Medical Center
  • Kessler Foundation
  • Rusk Rehabilitation
  • Sheltering Arms Physical Rehabilitation Hospitals
  • Shepherd Center, Atlanta GA
  • Shirley Ryan AbilityLab
  • St. Charles Hospital
  • TIRR Memorial Hermann

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 15, 2017
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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