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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCI Patients | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indego Powered Exoskeleton | Device | Subjects who have Spinal Cord Injury will wear the Indego device which will include being trained and evaluated for fifteen (15) sessions. |
|
| 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 |
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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
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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Charles Hospital | Port Jefferson | New York | United States | |||
| TIRR Memorial Hermann |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010264 | Paraplegia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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|
| Houston |
| Texas |
| - TIRR Memorial Hermann, |
| United States |
| Sheltering Arms | Mechanicsville | Virginia | 23116 | United States |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |