Trial Outcomes & Findings for Performance Attributes and User Progression While Using Ekso (NCT NCT02132702)
NCT ID: NCT02132702
Last Updated: 2024-10-08
Results Overview
Participants were scheduled to utilize exoskeleton 3x per week for 8 weeks. The number of participants who completed this dose was tracked.
COMPLETED
NA
60 participants
24 sessions
2024-10-08
Participant Flow
Participant milestones
| Measure |
Ekso Treatment
Ekso gait training 3x/week for 8 weeks. Utilized the EksoGT device for approximately 60 minutes per session
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Ekso Treatment
Ekso gait training 3x/week for 8 weeks. Utilized the EksoGT device for approximately 60 minutes per session
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Performance Attributes and User Progression While Using Ekso
Baseline characteristics by cohort
| Measure |
Ekso Treatment
n=52 Participants
Ekso gait training 3x/week for 8 weeks
|
|---|---|
|
Age, Continuous
|
35.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
10 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
24.1 kilogram/meters^2
n=5 Participants
|
|
Time since injury
Recently injured < or = 1 year
|
25 Participants
n=5 Participants
|
|
Time since injury
Chronically injured > 1 year
|
27 Participants
n=5 Participants
|
|
Neurological level of injury (NLI) and severity of injury at baseline
C1-C4 AIS A, B, C
|
0 Participants
n=5 Participants
|
|
Neurological level of injury (NLI) and severity of injury at baseline
C5-C8 AIS A, B, C
|
4 Participants
n=5 Participants
|
|
Neurological level of injury (NLI) and severity of injury at baseline
T1-S5 AIS A, B, C
|
29 Participants
n=5 Participants
|
|
Neurological level of injury (NLI) and severity of injury at baseline
All AIS D
|
19 Participants
n=5 Participants
|
|
Spinal cord injury aetiology
Sport/Leisure
|
16 Participants
n=5 Participants
|
|
Spinal cord injury aetiology
Assault
|
2 Participants
n=5 Participants
|
|
Spinal cord injury aetiology
Transport
|
17 Participants
n=5 Participants
|
|
Spinal cord injury aetiology
Fall
|
7 Participants
n=5 Participants
|
|
Spinal cord injury aetiology
Other traumatic cause
|
1 Participants
n=5 Participants
|
|
Spinal cord injury aetiology
Non-traumatic spinal cord dysfunction
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 sessionsParticipants were scheduled to utilize exoskeleton 3x per week for 8 weeks. The number of participants who completed this dose was tracked.
Outcome measures
| Measure |
Ekso Treatment
n=60 Participants
Ekso gait training 3x/week for 8 weeks
|
Chronically Injured Participants
Participants with injuries \> 1 year
|
|---|---|---|
|
Number of Participants Adherent to Gait Training Progression Using Ekso
|
52 Participants
|
—
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
The impact of Ekso training on muscle spasticity will be measured using the Modified Ashworth Scale (MAS)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Ekso Treatment
n=15 Participants
Ekso gait training 3x/week for 8 weeks
|
Chronically Injured Participants
n=12 Participants
Participants with injuries \> 1 year
|
|---|---|---|
|
Timed Up and Go (TUG)
Baseline
|
38.3 seconds
Interval 30.5 to 46.1
|
35 seconds
Interval 21.0 to 49.0
|
|
Timed Up and Go (TUG)
Session 12
|
36.6 seconds
Interval 29.0 to 44.2
|
31.4 seconds
Interval 17.4 to 45.4
|
|
Timed Up and Go (TUG)
Session 24
|
31.3 seconds
Interval 23.8 to 38.8
|
27.2 seconds
Interval 13.2 to 41.2
|
|
Timed Up and Go (TUG)
Follow up
|
28.3 seconds
Interval 20.8 to 35.8
|
28.7 seconds
Interval 14.7 to 42.6
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Ekso Treatment
n=15 Participants
Ekso gait training 3x/week for 8 weeks
|
Chronically Injured Participants
n=12 Participants
Participants with injuries \> 1 year
|
|---|---|---|
|
Muscle Strength
Baseline
|
19.4 units on a scale
Interval 11.6 to 27.3
|
14.5 units on a scale
Interval 7.7 to 21.3
|
|
Muscle Strength
Session 12
|
24.1 units on a scale
Interval 16.3 to 32.0
|
14.8 units on a scale
Interval 8.0 to 21.6
|
|
Muscle Strength
Follow up
|
24 units on a scale
Interval 16.1 to 31.8
|
14.7 units on a scale
Interval 7.8 to 21.5
|
SECONDARY outcome
Timeframe: 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
Evaluate the function of bowel and bladder as impacted by Ekso training using Modified International SCI Lower Urinary Tract Basic Data Set
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Ekso Treatment
n=25 Participants
Ekso gait training 3x/week for 8 weeks
|
Chronically Injured Participants
n=27 Participants
Participants with injuries \> 1 year
|
|---|---|---|
|
Functional Abilities
Baseline
|
62 score on a scale
Interval 51.0 to 73.0
|
73 score on a scale
Interval 64.0 to 77.0
|
|
Functional Abilities
Session 24
|
70 score on a scale
Interval 65.0 to 77.0
|
74 score on a scale
Interval 68.0 to 81.0
|
|
Functional Abilities
Follow up
|
73 score on a scale
Interval 67.5 to 78.0
|
74 score on a scale
Interval 71.0 to 78.0
|
SECONDARY outcome
Timeframe: 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
The effect of Ekso training on bowel function will be evaluated using Modified International SCI Bowel Function Basic Data Set
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Ekso Treatment
n=25 Participants
Ekso gait training 3x/week for 8 weeks
|
Chronically Injured Participants
n=27 Participants
Participants with injuries \> 1 year
|
|---|---|---|
|
Quality of Life - Satisfaction of Life
Baseline
|
5 score on a scale
Interval 3.0 to 7.0
|
6 score on a scale
Interval 5.0 to 7.0
|
|
Quality of Life - Satisfaction of Life
Session 24
|
6 score on a scale
Interval 4.5 to 8.0
|
7 score on a scale
Interval 6.0 to 9.0
|
|
Quality of Life - Satisfaction of Life
Follow up
|
6 score on a scale
Interval 4.0 to 8.0
|
8 score on a scale
Interval 7.0 to 8.0
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Ekso Treatment
n=15 Participants
Ekso gait training 3x/week for 8 weeks
|
Chronically Injured Participants
n=12 Participants
Participants with injuries \> 1 year
|
|---|---|---|
|
Berg Balance Scale (BBS) - Balance
Baseline
|
25.4 score on a scale
Interval 18.2 to 32.5
|
25 score on a scale
Interval 12.4 to 37.6
|
|
Berg Balance Scale (BBS) - Balance
Session 12
|
28.8 score on a scale
Interval 21.8 to 35.8
|
27.8 score on a scale
Interval 15.2 to 40.4
|
|
Berg Balance Scale (BBS) - Balance
Session 24
|
31.5 score on a scale
Interval 24.6 to 38.4
|
28.9 score on a scale
Interval 16.3 to 41.5
|
|
Berg Balance Scale (BBS) - Balance
Follow up
|
33.3 score on a scale
Interval 26.4 to 40.2
|
29 score on a scale
Interval 16.4 to 41.6
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Ekso Treatment
n=15 Participants
Ekso gait training 3x/week for 8 weeks
|
Chronically Injured Participants
n=12 Participants
Participants with injuries \> 1 year
|
|---|---|---|
|
10 Meter Walk Test - Gait Speed
Baseline
|
35.3 seconds
Interval 26.5 to 44.1
|
33.8 seconds
Interval 20.8 to 46.8
|
|
10 Meter Walk Test - Gait Speed
Session 12
|
35.8 seconds
Interval 27.1 to 44.4
|
33.2 seconds
Interval 20.2 to 46.2
|
|
10 Meter Walk Test - Gait Speed
Session 24
|
28.6 seconds
Interval 20.0 to 37.1
|
27.3 seconds
Interval 14.3 to 40.3
|
|
10 Meter Walk Test - Gait Speed
Follow up
|
26 seconds
Interval 17.5 to 34.4
|
27 seconds
Interval 14.0 to 40.0
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Ekso Treatment
n=15 Participants
Ekso gait training 3x/week for 8 weeks
|
Chronically Injured Participants
n=12 Participants
Participants with injuries \> 1 year
|
|---|---|---|
|
Gait Progression
Baseline
|
12.5 units on a scale
Interval 10.5 to 14.4
|
14 units on a scale
Interval 10.7 to 17.3
|
|
Gait Progression
Session 12
|
12.6 units on a scale
Interval 10.7 to 14.6
|
14.3 units on a scale
Interval 11.0 to 17.6
|
|
Gait Progression
Session 24
|
12.8 units on a scale
Interval 11.0 to 14.7
|
13.7 units on a scale
Interval 10.4 to 17.0
|
|
Gait Progression
Follow up
|
13.7 units on a scale
Interval 11.8 to 15.5
|
13.9 units on a scale
Interval 10.6 to 17.2
|
Adverse Events
Ekso Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ekso Treatment
n=60 participants at risk
Ekso gait training 3x/week for 8 weeks. While outcome measures were assessed in two groups, Recently Injured and Chronically Injured, adverse events were measured in one group out of all total participants because all participants underwent the same intervention (ie this one a 1-arm study)
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Ankle swelling
|
5.0%
3/60 • Number of events 3 • Study duration of 8 weeks plus 4 weeks of follow up
|
|
Cardiac disorders
dizziness or sycope
|
13.3%
8/60 • Number of events 8 • Study duration of 8 weeks plus 4 weeks of follow up
|
|
Nervous system disorders
Neurological symptoms
|
5.0%
3/60 • Number of events 3 • Study duration of 8 weeks plus 4 weeks of follow up
|
|
Skin and subcutaneous tissue disorders
Skin issues
|
15.0%
9/60 • Number of events 9 • Study duration of 8 weeks plus 4 weeks of follow up
|
|
General disorders
Concurrent medical issues
|
3.3%
2/60 • Number of events 2 • Study duration of 8 weeks plus 4 weeks of follow up
|
Additional Information
Carsten Bach Baunsgaard
Clinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place