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Indego Exoskeleton After SCI

Primary Purpose

Spinal Cord Injury

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

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Paraplegia, Gait, Exoskeleton

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years or older
  • Height 5'1" to 6'3" (Acceptable height may vary by a few inches depending on femur length)
  • Weight 250 lbs or less
  • Present with paraplegia resulting from a complete or incomplete (AIS A, B, C, or D) Spinal Cord Injury (>1 year post-injury), with preserved LE function
  • Uses wheelchair as primary means of mobility in the community
  • Able to ambulate 14 meters with assist of 2 people and no orthostasis. Subjects may use any combination of stability aids and/or bracing.

  • Medical clearance for weight bearing and locomotor training

    • Bone density exams will be at the discretion of each sites' Principle Investigator
  • Passive range of motion (PROM) at shoulders, trunk, hips, knees and ankles within functional limits for safe gait and use of appropriate assistive device/stability aid
  • Skin intact where interfaces with the Indego device
  • Modified Ashworth Scale 3 or less in bilateral LEs

  • Blood pressure and heart rate within Locomotor Training Guidelines

    • At rest: Systolic 150 or less Diastolic 90 or less and Heart rate 105 or less
    • Exercise: Systolic 180 or less Diastolic 105 or less and Heart Rate 145 or less

Exclusion Criteria:

  • Inability to meet ALL inclusion criteria
  • Currently participating in physical therapy for gait training
  • Joint contractures of the shoulders, trunk, hips knees or ankles deemed unsafe for locomotor training by PT and or MD
  • Edema that would put skin at risk for breakdown
  • Modified Ashworth Spasticity of 4
  • Inability to achieve adequate fit of the Indego device
  • Pregnancy
  • Colostomy bag

Sites / Locations

  • St. Charles Hospital
  • TIRR Memorial Hermann
  • Sheltering Arms

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SCI Patients

Arm Description

10 subjects with complete or incomplete SCI (> 1 year post-injury) with preserved LE function will be recruited. No control group

Outcomes

Primary Outcome Measures

Functional ambulation category (FAC) to measure gait quality
Categorizes patients according to basic motor skills necessary for functional ambulation
10 Meter Walking Test to measure fast gait speed
Assesses walking speed in meters per second over a short duration
6 Minute Walking test to measure endurance
Measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface

Secondary Outcome Measures

Full Information

First Posted
May 24, 2016
Last Updated
August 28, 2018
Sponsor
Parker Hannifin Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02793635
Brief Title
Indego Exoskeleton After SCI
Official Title
Impact of Gait Training With an Exoskeleton on Walking Function After Spinal Cord Injury (SCI)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parker Hannifin Corporation

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the use of Indego as a gait training tool for subjects with complete or incomplete paraplegia as a result of spinal cord injury (SCI) who have preserved lower extremity function. It is hypothesized that subjects with complete or incomplete paraplegia who have preserved their lower extremity function will experience functional improvements after gait training with the Indego exoskeleton. Subjects will complete a total of fifteen (15) sessions which include a combination of the following; Physical Therapy Evaluation, Indego Training, Mid-Way Assessment, and Post-Assessment. The aim of this study is to measure the impact of gait training with the Indego device on body structure, function, and participation. Additionally it will assess the perceptions of physical therapists and subjects with SCI on the effectiveness of gait training with the Indego exoskeleton in subjects with preserved limited function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Paraplegia, Gait, Exoskeleton

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
SCI Patients
Arm Type
Experimental
Arm Description
10 subjects with complete or incomplete SCI (> 1 year post-injury) with preserved LE function will be recruited. No control group
Intervention Type
Device
Intervention Name(s)
Indego Powered Exoskeleton
Other Intervention Name(s)
Vanderbilt exoskeleton
Intervention Description
Subjects who have Spinal Cord Injury will wear the Indego device which will include being trained and evaluated for fifteen (15) sessions.
Primary Outcome Measure Information:
Title
Functional ambulation category (FAC) to measure gait quality
Description
Categorizes patients according to basic motor skills necessary for functional ambulation
Time Frame
1 Day
Title
10 Meter Walking Test to measure fast gait speed
Description
Assesses walking speed in meters per second over a short duration
Time Frame
1 Day
Title
6 Minute Walking test to measure endurance
Description
Measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
Time Frame
6 Minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Height 5'1" to 6'3" (Acceptable height may vary by a few inches depending on femur length) Weight 250 lbs or less Present with paraplegia resulting from a complete or incomplete (AIS A, B, C, or D) Spinal Cord Injury (>1 year post-injury), with preserved LE function Uses wheelchair as primary means of mobility in the community Able to ambulate 14 meters with assist of 2 people and no orthostasis. Subjects may use any combination of stability aids and/or bracing. Medical clearance for weight bearing and locomotor training Bone density exams will be at the discretion of each sites' Principle Investigator Passive range of motion (PROM) at shoulders, trunk, hips, knees and ankles within functional limits for safe gait and use of appropriate assistive device/stability aid Skin intact where interfaces with the Indego device Modified Ashworth Scale 3 or less in bilateral LEs Blood pressure and heart rate within Locomotor Training Guidelines At rest: Systolic 150 or less Diastolic 90 or less and Heart rate 105 or less Exercise: Systolic 180 or less Diastolic 105 or less and Heart Rate 145 or less Exclusion Criteria: Inability to meet ALL inclusion criteria Currently participating in physical therapy for gait training Joint contractures of the shoulders, trunk, hips knees or ankles deemed unsafe for locomotor training by PT and or MD Edema that would put skin at risk for breakdown Modified Ashworth Spasticity of 4 Inability to achieve adequate fit of the Indego device Pregnancy Colostomy bag
Facility Information:
Facility Name
St. Charles Hospital
City
Port Jefferson
State/Province
New York
Country
United States
Facility Name
TIRR Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
- TIRR Memorial Hermann,
Country
United States
Facility Name
Sheltering Arms
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Indego Exoskeleton After SCI

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