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).

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiplegia; Cerebrovascular Accident (CVA)
• Intervention / Treatment: Device: Indego Exoskeleton

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Health System
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Shepherd Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Rehabilitation Institute of Chicago (Shirley Ryan AbilityLab)
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation
  • New York
    • Port Jefferson, New York, United States, 11777
      • St. Charles Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • TIRR Memorial Hermann
  • Virginia
    • Mechanicsville, Virginia, United States, 23116
      • Sheltering Arms Physical Rehabilitation Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2017
• Primary Completion (Actual): December 28, 2017
• Study Completion (Actual): January 17, 2018

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 15, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia
• Other Study ID Numbers: PHIND_CVA01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No