search
Back to results

Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

Primary Purpose

Cerebrovascular Accident (CVA), Stroke, Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indego Exoskeleton
Sponsored by
Parker Hannifin Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebrovascular Accident (CVA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Health System
  • Shepherd Center
  • Rehabilitation Institute of Chicago (Shirley Ryan AbilityLab)
  • Kessler Foundation
  • St. Charles Hospital
  • TIRR Memorial Hermann
  • Sheltering Arms Physical Rehabilitation Centers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Enrolled Subjects

Arm Description

All enrolled subjects will receive gait training with the Indego.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Gait Speed (Without Indego) Measured With 10 Meter Walk Test
10 Meter Walk Test (MWT) without Indego to measure gait speed
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

Full Information

First Posted
February 13, 2017
Last Updated
March 24, 2020
Sponsor
Parker Hannifin Corporation
Collaborators
Shepherd Center, Atlanta GA, Cedars-Sinai Medical Center, Sheltering Arms Physical Rehabilitation Hospitals, Shirley Ryan AbilityLab, Kessler Foundation, St. Charles Hospital, TIRR Memorial Hermann, Rusk Rehabilitation
search

1. Study Identification

Unique Protocol Identification Number
NCT03054064
Brief Title
Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA
Official Title
Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
December 28, 2017 (Actual)
Study Completion Date
January 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parker Hannifin Corporation
Collaborators
Shepherd Center, Atlanta GA, Cedars-Sinai Medical Center, Sheltering Arms Physical Rehabilitation Hospitals, Shirley Ryan AbilityLab, Kessler Foundation, St. Charles Hospital, TIRR Memorial Hermann, Rusk Rehabilitation

4. Oversight

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

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident (CVA), Stroke, Hemiplegia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Enrolled Subjects
Arm Type
Experimental
Arm Description
All enrolled subjects will receive gait training with the Indego.
Intervention Type
Device
Intervention Name(s)
Indego Exoskeleton
Intervention Description
Six study sessions including five Indego training sessions over two weeks.
Primary Outcome Measure Information:
Title
Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events
Description
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
Secondary Outcome Measure Information:
Title
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale
Description
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
Title
Activity Measured by Functional Ambulation Category
Description
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
Time Frame
2 weeks
Title
Gait Speed (Without Indego) Measured With 10 Meter Walk Test
Description
10 Meter Walk Test (MWT) without Indego to measure gait speed
Time Frame
2 weeks
Title
Pain Measured With Face, Legs, Activity, Cry, Consolability Scale
Description
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
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cedars-Sinai Health System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Rehabilitation Institute of Chicago (Shirley Ryan AbilityLab)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
St. Charles Hospital
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11777
Country
United States
Facility Name
TIRR Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sheltering Arms Physical Rehabilitation Centers
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

We'll reach out to this number within 24 hrs