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Indego Exoskeleton After SCI

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02793635
First received: May 24, 2016
Last updated: March 2, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Spinal Cord Injury
Device: Indego Powered Exoskeleton

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Impact of Gait Training With an Exoskeleton on Walking Function After Spinal Cord Injury (SCI)

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Functional ambulation category (FAC) to measure gait quality [ Time Frame: 1 Day ]
    Categorizes patients according to basic motor skills necessary for functional ambulation

  • 10 Meter Walking Test to measure fast gait speed [ Time Frame: 1 Day ]
    Assesses walking speed in meters per second over a short duration

  • 6 Minute Walking test to measure endurance [ Time Frame: 6 Minutes ]
    Measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface


Estimated Enrollment: 25
Study Start Date: June 2016
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCI Patients
  • 18 - 25 subjects (3 - 5 subjects per site) 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 Name: Vanderbilt exoskeleton

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02793635

Contacts
Contact: Olanta Chandler bartoo02@nyumc.org

Locations
United States, California
Cedars Sinai Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Pamela Roberts       Pamela.Roberts@cshs.org   
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Olanta Chandler       olanta.chandler@nyumc.org   
Principal Investigator: Tamara Bushnik, MD         
St. Charles Hospital Not yet recruiting
Port Jefferson, New York, United States
Contact: Jennifer Semel       Jennifer.Semel@chsli.org   
United States, Texas
TIRR Memorial Hermann Not yet recruiting
Houston, Texas, United States, - TIRR Memorial Hermann,
Contact: Gerard Francisco       Gerard.E.Francisco@uth.tmc.edu   
United States, Virginia
Sheltering Arms Recruiting
Mechanicville, Virginia, United States, 23116
Contact: Ambers Devers       amdevers@shelteringarms.com   
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Tamara Bushnik, MD New York University Langone Medical Center
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02793635     History of Changes
Other Study ID Numbers: 15-01399
Study First Received: May 24, 2016
Last Updated: March 2, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by New York University School of Medicine:
Paraplegia
Gait
Exoskeleton

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2017