Indego Exoskeleton After SCI

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: Indego Powered Exoskeleton


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCI Patients<br>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<br>* Subjects who have Spinal Cord Injury will wear the Indego device which will include being trained and evaluated for fifteen (15) sessions.<br>* Other names: Vanderbilt exoskeleton;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paraplegia, Gait, Exoskeleton