Performance Attributes and User Progression While Using Ekso

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the performance attributes and user progression of participants with motor complete and incomplete spinal cord injury (SCI) while utilizing the Ekso robotic exoskeleton in an eight week over ground, locomotor program. We hypothesize an improvement in progression and overall health while using Ekso.

Official Title
-----------------
Performance Attributes and User Progression While Using Ekso Robotic Exoskeleton in an Eight Week, Over Ground, Locomotor Program in Individuals With Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: Ekso


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatient or outpatient from 15 through 65 years of age at time of entry into the trial Motor complete (ASIA Impairment Scale [AIS] A and B), with a neurological level of injury (NLI) between C7-L2 (inclusive), or motor incomplete (AIS C and D), NLI C1-L2 (inclusive), as determined by the International Standards for Neurological Classification of SCI (ISNCSCI) Greater than 30 days since SCI occurred Height from 157 - 188 centimeters (5'2 to 6'2) or for individuals who do not meet this criteria the following criteria may be used as assessed per the Ekso operating manual: Max hip width= 16.5 or 42cm Upper leg length= 20 to 24⅛ or 51cm to 61.4cm Lower leg length= 19 to 25 or 48cm to 63.4cm Maximum weight of 100 kilograms (220 pounds) Sufficient upper extremity (UE) strength to use a front wheeled walker (FWW) either by manual muscle testing (MMT) (minimum triceps strength bilaterally of 3/5, shoulder abduction/adduction and flexion/extension 4/5) and/or by functional standing test with FWW. Participants with impaired hand function may use cuff grips. Sufficient range of motion (ROM) to achieve a normal, reciprocal gait pattern, and normal sit to stand transitions. Hip extension greater than or equal to 5 degrees Knee extension greater than or equal to 5 degrees Ankle dorsiflexion greater than or equal to 0 degrees Demonstrate adequate trunk stability and upper extremity strength to utilize Ekso as evidenced by the ability to complete a level (or near level) surface wheelchair to mat transfer with minimal assistance. Medically stable and cleared by a physician for full weight bearing locomotor training including 15 minute standing frame trial to assess standing tolerance Exclusion Criteria: Have trained in Ekso in the past except for one or two training/demonstration sessions Utilizing another robotic device for locomotor training Any medical issue that in the opinion of the Investigator precludes full weight bearing locomotor training including but not limited to: Spinal instability (or spinal orthotic unless cleared by physician) Acute deep vein thrombosis (DVT) with activity restrictions Severe, recurrent autonomic dysreflexia (AD) requiring medical intervention Heterotopic ossification (HO) in the lower extremities resulting in ROM restrictions at the hips or knees Two or more pathological fractures in the last 48 months in a major weight bearing bone (femur or tibia) in the lower extremity Hip subluxation (x-rays will be obtained for individuals injured prior to 10 years of age) Any medical issue that in the opinion of the Investigator would affect participant safety either due to cognitive deficits/impulsivity, intolerance to mild exercise or other factors Any issue that in the opinion of the Investigator would confound results such as a concurrent neurological injury or disorder (other than SCI) or other factors Modified Ashworth Scale (MAS) = 4 in the majority of lower extremity joints (e.g. greater than or equal to four joint movements in bilateral lower extremities when testing hip flexion/extension, knee flexion/extension, ankle dorsi/plantar flexion) Skin integrity issues in areas that contact the device (including abdominal ostomies) or that would prohibit sitting Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ekso treatment<br> | Device: Ekso<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants able to complete gait training progression using Ekso | To evaluate the performance attributes and user progression of participants with motor complete and incomplete spinal cord injury (SCI) while utilizing the Ekso robotic exoskeleton in an eight week over ground, locomotor program. The user will be trained with 1 person assisting without an overhead tether in multiple modes and levels of assist while maintaining safety. The following will indicate completion of training: number of Ekso sessions completed, ability to train in ProStep on or before session #24 without a tether, number of steps in device, time spent walking in device, and the duration of training sessions in each mode. | baseline (1st session), session #1, session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Effect | The heart rate and blood pressure while sitting, at rest, and during activity will be taken to measure cardiovascular health changes. The perceived rate of exertion will also be used to determine cardiovascular effect. | baseline (1st session), session #1, session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. | 
| Impact of Ekso Training on Spasticity | The impact of Ekso training on muscle spasticity will be measured using the Modified Ashworth Scale (MAS) | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. | 
| Mobility Progression | Impact of Ekso training on gait in participants who are ambulatory prior to Ekso training. Gait progression will be evaluated in individuals with motor incomplete SCI who are ambulatory outside of Ekso. They will utilize Timed Up and Go (TUG) to monitor mobility. | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. | 
| Impact of Ekso Training on Strength | The muscle strength of users will be analyzed to see if there is any gain in strength due to the Ekso training program. | baseline (1st session), after session #1, session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. | 
| Change in Bladder Function | Evaluate the function of bowel and bladder as impacted by Ekso training using Modified International SCI Lower Urinary Tract Basic Data Set | baseline (1st session), after session #1, session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. | 
| Functional Abilities | Functional abilities will be measured based on Spinal Cord Independence Measure II (SCIM II) | baseline, session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. | 
| Change in Bowel Function | The effect of Ekso training on bowel function will be evaluated using Modified International SCI Bowel Function Basic Data Set | baseline (1st session), session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. | 
| Quality of Life | The Quality of Life change due to Ekso training will be evaluated using the International SCI Quality of Life Basic Data Sheet | baseline (1st session),session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. | 
| Balance | Impact of Ekso training on gait in participants who are ambulatory prior to Ekso training. Gait progression will be evaluated in individuals with motor incomplete SCI who are ambulatory outside of Ekso. They will utilize Berg Balance Scale (BBS) to measure balance. | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. | 
| Gait Speed | Impact of Ekso training on gait in participants who are ambulatory prior to Ekso training. Gait progression will be evaluated in individuals with motor incomplete SCI who are ambulatory outside of Ekso. They will utilize a 10 Meter Walk Test to analyze gait speed. | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. | 
| Gait Progression | Impact of Ekso training on gait in participants who are ambulatory prior to Ekso training. Gait progression will be evaluated in individuals with motor incomplete SCI who are ambulatory outside of Ekso. They will utilize the Walking Index for Spinal Cord Injury II (WISCI II) and note any changes in walking assistive device utilized. | baseline (1st session), session #12, session #24, followup at 12 weeks. Sessions occur 3x/week over an 8 week training period with a follow up visit at week 12. |