Spinal Cord Injury
Conditions
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.
Interventions
DEVICEEkso
Sponsors
Glostrup University Hospital, Copenhagen
Ekso Bionics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
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. 1. Hip extension greater than or equal to 5 degrees 2. Knee extension greater than or equal to 5 degrees 3. 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: 1. Spinal instability (or spinal orthotic unless cleared by physician) 2. Acute deep vein thrombosis (DVT) with activity restrictions 3. Severe, recurrent autonomic dysreflexia (AD) requiring medical intervention 4. Heterotopic ossification (HO) in the lower extremities resulting in ROM restrictions at the hips or knees 5. Two or more pathological fractures in the last 48 months in a major weight bearing bone (femur or tibia) in the lower extremity 6. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Adherent to Gait Training Progression Using Ekso | 24 sessions | Participants were scheduled to utilize exoskeleton 3x per week for 8 weeks. The number of participants who completed this dose was tracked. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Ekso Training on Spasticity | 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. | The impact of Ekso training on muscle spasticity will be measured using the Modified Ashworth Scale (MAS) |
| Timed Up and Go (TUG) | 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 gait in participants who are ambulatory prior to Ekso training will be evaluated while not wearing the exoskeleton. Participants evaluated are those with ambulatory abilities outside of Ekso and therefore can complete test. This ambulatory ability could have been present at baseline testing, or participants may have acquired walking ability during the course of this study. Participant begins in a standard arm chair sitting back, stands, walks 3 meters, turns around, walks back, and sits into the chair. The time it takes to complete this sequence of movements is tracked. |
| Muscle Strength | 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. | The muscle strength of each of 5 key lower extremity muscles on each leg will be analyzed on a scale of 0-5. Lower extremity muscle scores are then added together to give a full lower extremity muscle score with a minimum score of 0 and a maximum score of 50. For each muscle: 0=None; No visible or palpable contraction. 1=Trace; Visible or palpable contraction with no motion. 2=Poor; Full range of motion (ROM) gravity eliminated. 3=Fair; Full ROM against gravity. 4=Good; Full ROM against gravity, moderate resistance. 5=Normal; Full ROM against gravity, maximal resistance. Higher LEMS scores (closer to 50) indicate higher strength towards typical, unimpaired muscle strength. Scores that are lower, close to or at 0, indicate little to no strength in the lower extremities. |
| Change in Bladder Function | 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. | Evaluate the function of bowel and bladder as impacted by Ekso training using Modified International SCI Lower Urinary Tract Basic Data Set |
| Functional Abilities | 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. | Functional abilities will be measured based on Spinal Cord Independence Measure II (SCIM II). This assessment is scored from 0-100 with higher numbers equating to higher function/ more independence. |
| 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. | 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. |
| Gait Progression | 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 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. Scores on the WISCI II range from 0 to 20. A higher score indicates the participant can walk more independently (from braces, assistive device, and hands on assistance) whereas a lower score indicates that a participants requires assistance from a brace, assistive device, and/or another person. |
| Quality of Life - Satisfaction of Life | 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. | The Quality of Life change due to Ekso training will be evaluated using the International SCI Quality of Life Basic Data Sheet. Scores are from 1-10 with 1= completely dissatisfied and 10=completely satisfied. |
| Berg Balance Scale (BBS) - 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. | 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. The BBS includes 14 tasks each scored from 0-4, and the point value given for each of the 14 items is then summed together to yield a final score. Total BBS scores are out of 56 possible points where the higher the score, the better the balance is and therefore the lower the risk of falls. Scores can range from 0 to 56. A score or \<45/56 is a commonly used standard that indicates individuals may be at greater risk of falling |
| 10 Meter Walk Test - 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. | 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. Participants will walk over a 10 meter strip and the time taken to complete this is recorded. |
| Change in Bowel Function | 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. | The effect of Ekso training on bowel function will be evaluated using Modified International SCI Bowel Function Basic Data Set |
Countries
Denmark, Germany, Netherlands, Norway, Spain, Sweden, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ekso Treatment Ekso gait training 3x/week for 8 weeks | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Ekso Treatment |
|---|---|
| Age, Continuous | 35.8 years |
| Body Mass Index (BMI) | 24.1 kilogram/meters^2 |
| Neurological level of injury (NLI) and severity of injury at baseline All AIS D | 19 Participants |
| Neurological level of injury (NLI) and severity of injury at baseline C1-C4 AIS A, B, C | 0 Participants |
| Neurological level of injury (NLI) and severity of injury at baseline C5-C8 AIS A, B, C | 4 Participants |
| Neurological level of injury (NLI) and severity of injury at baseline T1-S5 AIS A, B, C | 29 Participants |
| Region of Enrollment Denmark | 12 participants |
| Region of Enrollment Germany | 8 participants |
| Region of Enrollment Netherlands | 2 participants |
| Region of Enrollment Norway | 4 participants |
| Region of Enrollment Spain | 10 participants |
| Region of Enrollment Sweden | 10 participants |
| Region of Enrollment Switzerland | 6 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 36 Participants |
| Spinal cord injury aetiology Assault | 2 Participants |
| Spinal cord injury aetiology Fall | 7 Participants |
| Spinal cord injury aetiology Non-traumatic spinal cord dysfunction | 9 Participants |
| Spinal cord injury aetiology Other traumatic cause | 1 Participants |
| Spinal cord injury aetiology Sport/Leisure | 16 Participants |
| Spinal cord injury aetiology Transport | 17 Participants |
| Time since injury Chronically injured > 1 year | 27 Participants |
| Time since injury Recently injured < or = 1 year | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 22 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Number of Participants Adherent to Gait Training Progression Using Ekso
Participants were scheduled to utilize exoskeleton 3x per week for 8 weeks. The number of participants who completed this dose was tracked.
Time frame: 24 sessions
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ekso Treatment | Number of Participants Adherent to Gait Training Progression Using Ekso | 52 Participants |
Secondary
10 Meter Walk Test - 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. Participants will walk over a 10 meter strip and the time taken to complete this is recorded.
Time frame: 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.
Population: Subanalysis completed based on data collected
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ekso Treatment | 10 Meter Walk Test - Gait Speed | Baseline | 35.3 seconds |
| Ekso Treatment | 10 Meter Walk Test - Gait Speed | Session 12 | 35.8 seconds |
| Ekso Treatment | 10 Meter Walk Test - Gait Speed | Session 24 | 28.6 seconds |
| Ekso Treatment | 10 Meter Walk Test - Gait Speed | Follow up | 26 seconds |
| Chronically Injured Participants | 10 Meter Walk Test - Gait Speed | Follow up | 27 seconds |
| Chronically Injured Participants | 10 Meter Walk Test - Gait Speed | Baseline | 33.8 seconds |
| Chronically Injured Participants | 10 Meter Walk Test - Gait Speed | Session 24 | 27.3 seconds |
| Chronically Injured Participants | 10 Meter Walk Test - Gait Speed | Session 12 | 33.2 seconds |
Secondary
Berg Balance Scale (BBS) - 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. The BBS includes 14 tasks each scored from 0-4, and the point value given for each of the 14 items is then summed together to yield a final score. Total BBS scores are out of 56 possible points where the higher the score, the better the balance is and therefore the lower the risk of falls. Scores can range from 0 to 56. A score or \<45/56 is a commonly used standard that indicates individuals may be at greater risk of falling
Time frame: 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.
Population: Subset of total participants based on data collection
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ekso Treatment | Berg Balance Scale (BBS) - Balance | Session 12 | 28.8 score on a scale |
| Ekso Treatment | Berg Balance Scale (BBS) - Balance | Session 24 | 31.5 score on a scale |
| Ekso Treatment | Berg Balance Scale (BBS) - Balance | Follow up | 33.3 score on a scale |
| Ekso Treatment | Berg Balance Scale (BBS) - Balance | Baseline | 25.4 score on a scale |
| Chronically Injured Participants | Berg Balance Scale (BBS) - Balance | Follow up | 29 score on a scale |
| Chronically Injured Participants | Berg Balance Scale (BBS) - Balance | Baseline | 25 score on a scale |
| Chronically Injured Participants | Berg Balance Scale (BBS) - Balance | Session 12 | 27.8 score on a scale |
| Chronically Injured Participants | Berg Balance Scale (BBS) - Balance | Session 24 | 28.9 score on a scale |
Secondary
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.
Time frame: 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.
Population: Data not collected
Secondary
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
Time frame: 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.
Population: Data not collected
Secondary
Change in Bowel Function
The effect of Ekso training on bowel function will be evaluated using Modified International SCI Bowel Function Basic Data Set
Time frame: 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.
Population: Data not collected
Secondary
Functional Abilities
Functional abilities will be measured based on Spinal Cord Independence Measure II (SCIM II). This assessment is scored from 0-100 with higher numbers equating to higher function/ more independence.
Time frame: 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.
Population: 8 total drop outs
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ekso Treatment | Functional Abilities | Follow up | 73 score on a scale |
| Ekso Treatment | Functional Abilities | Baseline | 62 score on a scale |
| Ekso Treatment | Functional Abilities | Session 24 | 70 score on a scale |
| Chronically Injured Participants | Functional Abilities | Follow up | 74 score on a scale |
| Chronically Injured Participants | Functional Abilities | Baseline | 73 score on a scale |
| Chronically Injured Participants | Functional Abilities | Session 24 | 74 score on a scale |
Secondary
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. Scores on the WISCI II range from 0 to 20. A higher score indicates the participant can walk more independently (from braces, assistive device, and hands on assistance) whereas a lower score indicates that a participants requires assistance from a brace, assistive device, and/or another person.
Time frame: 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.
Population: Subset analysis based on full data collection
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ekso Treatment | Gait Progression | Baseline | 12.5 units on a scale |
| Ekso Treatment | Gait Progression | Session 12 | 12.6 units on a scale |
| Ekso Treatment | Gait Progression | Session 24 | 12.8 units on a scale |
| Ekso Treatment | Gait Progression | Follow up | 13.7 units on a scale |
| Chronically Injured Participants | Gait Progression | Follow up | 13.9 units on a scale |
| Chronically Injured Participants | Gait Progression | Baseline | 14 units on a scale |
| Chronically Injured Participants | Gait Progression | Session 24 | 13.7 units on a scale |
| Chronically Injured Participants | Gait Progression | Session 12 | 14.3 units on a scale |
Secondary
Impact of Ekso Training on Spasticity
The impact of Ekso training on muscle spasticity will be measured using the Modified Ashworth Scale (MAS)
Time frame: 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.
Population: Data not collected
Secondary
Muscle Strength
The muscle strength of each of 5 key lower extremity muscles on each leg will be analyzed on a scale of 0-5. Lower extremity muscle scores are then added together to give a full lower extremity muscle score with a minimum score of 0 and a maximum score of 50. For each muscle: 0=None; No visible or palpable contraction. 1=Trace; Visible or palpable contraction with no motion. 2=Poor; Full range of motion (ROM) gravity eliminated. 3=Fair; Full ROM against gravity. 4=Good; Full ROM against gravity, moderate resistance. 5=Normal; Full ROM against gravity, maximal resistance. Higher LEMS scores (closer to 50) indicate higher strength towards typical, unimpaired muscle strength. Scores that are lower, close to or at 0, indicate little to no strength in the lower extremities.
Time frame: 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.
Population: Sub analysis completed based on data collected
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ekso Treatment | Muscle Strength | Baseline | 19.4 units on a scale |
| Ekso Treatment | Muscle Strength | Session 12 | 24.1 units on a scale |
| Ekso Treatment | Muscle Strength | Follow up | 24 units on a scale |
| Chronically Injured Participants | Muscle Strength | Baseline | 14.5 units on a scale |
| Chronically Injured Participants | Muscle Strength | Session 12 | 14.8 units on a scale |
| Chronically Injured Participants | Muscle Strength | Follow up | 14.7 units on a scale |
Secondary
Quality of Life - Satisfaction of Life
The Quality of Life change due to Ekso training will be evaluated using the International SCI Quality of Life Basic Data Sheet. Scores are from 1-10 with 1= completely dissatisfied and 10=completely satisfied.
Time frame: 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.
Population: 8 total dropouts
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ekso Treatment | Quality of Life - Satisfaction of Life | Follow up | 6 score on a scale |
| Ekso Treatment | Quality of Life - Satisfaction of Life | Baseline | 5 score on a scale |
| Ekso Treatment | Quality of Life - Satisfaction of Life | Session 24 | 6 score on a scale |
| Chronically Injured Participants | Quality of Life - Satisfaction of Life | Baseline | 6 score on a scale |
| Chronically Injured Participants | Quality of Life - Satisfaction of Life | Session 24 | 7 score on a scale |
| Chronically Injured Participants | Quality of Life - Satisfaction of Life | Follow up | 8 score on a scale |
Secondary
Timed Up and Go (TUG)
Impact of Ekso training on gait in participants who are ambulatory prior to Ekso training will be evaluated while not wearing the exoskeleton. Participants evaluated are those with ambulatory abilities outside of Ekso and therefore can complete test. This ambulatory ability could have been present at baseline testing, or participants may have acquired walking ability during the course of this study. Participant begins in a standard arm chair sitting back, stands, walks 3 meters, turns around, walks back, and sits into the chair. The time it takes to complete this sequence of movements is tracked.
Time frame: 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.
Population: Subset analysis based on data collection
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ekso Treatment | Timed Up and Go (TUG) | Follow up | 28.3 seconds |
| Ekso Treatment | Timed Up and Go (TUG) | Session 24 | 31.3 seconds |
| Ekso Treatment | Timed Up and Go (TUG) | Baseline | 38.3 seconds |
| Ekso Treatment | Timed Up and Go (TUG) | Session 12 | 36.6 seconds |
| Chronically Injured Participants | Timed Up and Go (TUG) | Follow up | 28.7 seconds |
| Chronically Injured Participants | Timed Up and Go (TUG) | Session 12 | 31.4 seconds |
| Chronically Injured Participants | Timed Up and Go (TUG) | Session 24 | 27.2 seconds |
| Chronically Injured Participants | Timed Up and Go (TUG) | Baseline | 35 seconds |