Indego Exoskeleton After SCI

Impact of Gait Training With an Exoskeleton on Walking Function After Spinal Cord Injury (SCI)

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: Indego Powered Exoskeleton

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Port Jefferson, New York, United States
      • St. Charles Hospital
  • Texas
    • Houston, Texas, United States, - TIRR Memorial Hermann,
      • TIRR Memorial Hermann
  • Virginia
    • Mechanicsville, Virginia, United States, 23116
      • Sheltering Arms

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: SCI Patients; 10 subjects with complete or incomplete SCI (> 1 year post-injury) with preserved LE function will be recruited.; No control group	Device: Indego Powered Exoskeleton; Subjects who have Spinal Cord Injury will wear the Indego device which will include being trained and evaluated for fifteen (15) sessions.; Other Names: Vanderbilt exoskeleton

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional ambulation category (FAC) to measure gait quality	Categorizes patients according to basic motor skills necessary for functional ambulation	1 Day
10 Meter Walking Test to measure fast gait speed	Assesses walking speed in meters per second over a short duration	1 Day
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	6 Minutes

Collaborators and Investigators

• Sponsor: Parker Hannifin Corporation

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: May 24, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 8, 2016

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Gait; Exoskeleton; Paraplegia
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 15-01399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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