Status:
COMPLETED
Indego Exoskeleton After SCI
Lead Sponsor:
Parker Hannifin Corporation
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18+ years
Phase:
NA
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 ex...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02793635
Start Date
June 1 2016
End Date
March 1 2018
Last Update
August 31 2018
Active Locations (3)
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1
St. Charles Hospital
Port Jefferson, New York, United States
2
TIRR Memorial Hermann
Houston, Texas, United States, - TIRR Memorial Hermann,
3
Sheltering Arms
Mechanicsville, Virginia, United States, 23116