Indego Exoskeleton After SCI

NCT02793635 | Completed FDA Device

• 1 other identifier: 15-01399
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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.

Conditions

Spinal Cord Injury

Keywords

Paraplegia; Gait; Exoskeleton

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

SCI Patients

EXPERIMENTAL

* 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

Interventions

Indego Powered Exoskeleton DEVICE

Subjects who have Spinal Cord Injury will wear the Indego device which will include being trained and evaluated for fifteen (15) sessions.

Also known as: Vanderbilt exoskeleton

SCI Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Parker Hannifin Corporation: lead

Study Sites (3)

St. Charles Hospital

Port Jefferson, New York, United States

Location

TIRR Memorial Hermann

Houston, Texas, - TIRR Memorial Hermann,, United States

Location

Sheltering Arms

Mechanicsville, Virginia, 23116, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 8, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

US (3)