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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
New York
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Port Jefferson, New York, United States
- St. Charles Hospital
-
-
Texas
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Houston, Texas, United States, - TIRR Memorial Hermann,
- TIRR Memorial Hermann
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Virginia
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Mechanicsville, Virginia, United States, 23116
- Sheltering Arms
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SCI Patients
|
Subjects who have Spinal Cord Injury will wear the Indego device which will include being trained and evaluated for fifteen (15) sessions.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional ambulation category (FAC) to measure gait quality
Time Frame: 1 Day
|
Categorizes patients according to basic motor skills necessary for functional ambulation
|
1 Day
|
|
10 Meter Walking Test to measure fast gait speed
Time Frame: 1 Day
|
Assesses walking speed in meters per second over a short duration
|
1 Day
|
|
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
|
6 Minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-01399
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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