Indego Exoskeleton After SCI

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793635
• Other study ID #: 15-01399
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: March 2018

Study information

• Verified date: August 2018
• Source: Parker Hannifin Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.

Locations

Country	Name	City	State
United States	TIRR Memorial Hermann	Houston	Texas
United States	Sheltering Arms	Mechanicsville	Virginia
United States	St. Charles Hospital	Port Jefferson	New York

Sponsors (1)

Lead Sponsor	Collaborator
Parker Hannifin Corporation

Country where clinical trial is conducted

United States, 

Outcome

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