Indego Exoskeleton After SCI
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/2/2018 |
| Start Date: | June 2016 |
| End Date: | March 2018 |
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.
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.
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
We found this trial at
3
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials