Injuries, Spinal Cord
Conditions
Keywords
Spinal Cord, Injury, Exoskeleton, Ekso, Rehabilitation
Brief summary
A randomized, controlled trial comparing exoskeleton gait training with standard gait training or no gait training in community-dwelling participants with chronic incomplete spinal cord injury
Detailed description
Community dwelling iSCI participants may improve clinical gait function by engaging in a gait training regimen, where robotic exoskeletons can readily deliver a precise dose and simultaneously reduce the physical stress imposed on therapists using conventional manually assisted stepping practice. Exoskeleton training is predicted to improve function in participants receiving usual care, but not superior to intensity-matched manual training. The rationale to implement exoskeleton robotics as preference in gait training is based on precision dosing, over-ground training, and reduced therapist burden for high repetition training. The investigators aim to demonstrate that Ekso exoskeleton training can significantly improve gait speed in stable chronic, community-dwelling incomplete SCI (iSCI) participants. The objectives of this study are the following: A. Primary Objective: To demonstrate that a 12 week robotic gait training regimen can lead to a clinically meaningful improvement in independent gait speed on the 10 Meter Walk Test (10MWT) in community dwelling participants with chronic iSCI. B. Secondary Objectives: 1. To examine the economic factors such as number of physical therapists/staff required during training. 2. To analyze the physical burden on therapists assisting and supervising during training. 3. To study the influence of factors that may modify the gait recovery in the chronic incomplete SCI population (demographic, clinical, functional, psychological, balance, etc.).
Interventions
DEVICEEkso GT Rehabilitation Therapy
Walking Improvement for Spinal Cord Injuries with Exoskeleton
DEVICEBody Weight Supported (BWS) Treadmill Training
Standard gait training using BWS PT and overground training
Sponsors
Burke Medical Research Institute
Ekso Bionics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Motor incomplete paraplegia or tetraplegia 2. Neurological level of injury (NLI) C1- approximately T10 (inclusive, for upper motor neuron injuries only), as determined by the International Standards for Neurological Classification of SCI (ISNCSCI) 3. Sufficient diaphragmatic strength such that respiration is not compromised with exercise. 4. Sufficient upper extremity strength to use a front wheeled walker either by manual muscle testing (minimum triceps strength bilaterally of 3/5, shoulder abduction/adduction and flexion/extension 4/5) 5. AIS-C SCI & AIS-D SCI, as determined by the International Standards for Neurological Classification of SCI (ISNCSCI) 6. Ambulates at \<0.44 meters/second with or without physical assistance and assistance device 7. WISCI ≥ 1 8. 18 - 75 yrs, inclusive 9. No current or history of other neurological conditions 10. Screened and cleared by a physician 11. Involved in standing program or must be able to tolerate at least 15 min upright 12. Weigh 220 pounds (100kg) or less 13. Be able to fit into the Ekso device 14. Approximately between 5'0 and 6'4 tall 15. Standing hip width of approximately 18 or less 16. Have near normal range of motion in hips, knees and ankles
Exclusion criteria
1. AIS-A SCI or AIS-B SCI 2. Lower motor neuron injuries, as shown by absent reflexes during bilateral quadriceps and Achilles tendon taps 3. \< 3 months since previous intensive gait training regimen 4. Already walking at self-selected ambulation speeds of at least 0.44 meter/second with or without assistance 5. Currently involved in another intervention study 6. Concurrent neurological disease 7. Hip flexion contracture greater than \ 17° 8. Knee flexion contracture greater than 12° 9. Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral with max 12° knee flexion) 10. Leg length discrepancy 1. Greater than 0.5 for upper leg 2. Greater than 0.75 for lower leg 11. Spinal instability 12. Unresolved deep vein thrombosis 13. Uncontrolled autonomic dysreflexia 14. Severe muscular or skeletal pain 15. Spasticity that prevents joint motion (severe stiffness or rigidity,) where both legs have a Modified Ashworth Score (MAS) score of 3 or higher for half or more of their proximal lower extremity muscles; proximal muscles include hip flexors/extensors/adductors and knee flexors/extensors. 16. Open skin ulcerations on buttocks or other body surfaces in contact with exoskeleton or harness 17. Pregnancy 18. Cognitive impairments - unable to follow 2 steps commands and communicate for pain or to stop session 19. Shoulder extension Range of Motion (ROM) \< 50° excludes crutches during sit to stand or vice versa. (Walking with crutches permitted.) 20. Participant requires the assistance of more than one therapist to transfer safely. 21. Uncontrolled or severe orthostatic hypotension that limits standing tolerance; defined as sustained, symptomatic drops in systolic and diastolic blood pressure when moving from sitting to standing 22. Active heterotrophic ossification (HO), hip dysplasia or hip/knee axis abnormalities 23. Colostomy 24. History of long bone fractures since the SCI, secondary to osteoporosis 25. Unable to sustain current medication regimen 26. Any reason the physician may deem as harmful to the participant to enroll or continue in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT) | Baseline and 12 Weeks | The mean change in gait speed demonstrated during the 10MWT after 12 weeks of training and compared between groups. Positive values indicate improvement in gait speed (faster) from baseline to 12 weeks. Negative values indicate a reduction in gait speed (slower) from baseline to 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Met the Minimal Clinically Important Difference of 0.15m/s in Gait Speed Per 10 Meter Walk Test (10MWT) From Baseline to 24 Weeks | Between baseline and 24 weeks | Number of participants who achieve the Minimal Clinically Important Difference (MCID) of 0.15 m/s during the 10MWT when comparing between baseline gait speed and gait speed at 24 weeks. |
| Change in Distance Covered Over 6 Minutes From Baseline to 24 Weeks | Baseline-24 weeks | 6 minute walk test (6MWT) completed at baseline and 24 weeks. Change assessed. Positive values indicate an increase in distance was able to be walked at 24 weeks versus at baseline. Negative values indicate a decrease in distance was walked at 24 weeks versus at baseline. |
| Change in Time Required to Complete Timed Up and Go (TUG) Test From Baseline to 24 Week Follow up | Baseline and 24 weeks | Examined balance and walking in participants at baseline and follow up at 24 weeks. Positive values indicate an improvement of time (less time) required to complete task at 24 week follow up versus at baseline. Negative values indicate a decline, more time required to complete task at follow up versus baseline. |
| Number of Participants Who Experienced a Fall During Protocol | Throughout 24 weeks | At each training session, assessed if participant had experienced any falls. Count is number of participants who reported that yes, they did experience a fall. |
| Change in Berg Balance Scale Score From Baseline to 24 Weeks | Baseline-24 weeks | Measurement of static and dynamic sitting and standing balance completed at baseline and at 24 weeks. Berg balance scale is a 14 item test with each item scored from 0-4. Possible scores range from 0-56. Higher scores indicate a lower risk of falls and better balance. Positive numbers indicate an improvement in Berg balance scale (scored out of 56), meaning that the participant scored higher at 24 weeks than at baseline. Negative values indicate a decline in performance of the Berg balance scale (scored out of 56), meaning that the participant scored lower at 24 weeks than at baseline. |
Countries
United States
Participant flow
Pre-assignment details
Run-in category arm contains participants that began the intervention protocol to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol. Following the satisfactory completion of at least one set of midpoint assessments during the run-in phase, subsequent main study participants (a separate cohort) were enrolled and randomly assigned. Run-in participant data was not collected or included in these results.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Ekso GT Rehabilitation Therapy Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy
Ekso GT Rehabilitation Therapy: Walking Improvement for Spinal Cord Injuries with Exoskeleton | 12 |
| Group 2: Active Controls - BWSTT Therapy Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training
Body Weight Supported (BWS) Treadmill Training: Standard gait training using BWS PT and overground training | 12 |
| Group 3: Passive Controls Participants in this group continue with normal daily activities over 12 weeks. | 6 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | excluded | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 2: Active Controls - BWSTT Therapy | Group 3: Passive Controls | Total | Group 1: Ekso GT Rehabilitation Therapy |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 5 Participants | 27 Participants | 12 Participants |
| Age, Continuous | 51.91 years | 49 years | 47.2 years | 41.67 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | 12 Participants | 6 Participants | 30 Participants | 12 Participants |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 18 Participants | 7 Participants |
| Time since injury | 7.04 years STANDARD_DEVIATION 4.37 | 4.37 years STANDARD_DEVIATION 4.77 | 7.05 years STANDARD_DEVIATION 6.49 | 8.40 years STANDARD_DEVIATION 8.59 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 | 0 / 6 | 0 / 12 |
| other Total, other adverse events | 12 / 14 | 9 / 13 | 3 / 6 | 8 / 12 |
| serious Total, serious adverse events | 1 / 14 | 1 / 13 | 0 / 6 | 0 / 12 |
Outcome results
Primary
Change in Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT)
The mean change in gait speed demonstrated during the 10MWT after 12 weeks of training and compared between groups. Positive values indicate improvement in gait speed (faster) from baseline to 12 weeks. Negative values indicate a reduction in gait speed (slower) from baseline to 12 weeks.
Time frame: Baseline and 12 Weeks
Population: Population does not include participants who withdrew, who did not have completed outcome data, who were excluded, or who were included in the Ekso protocol run-in. Run in participants did not have data collected on them and were only utilized to to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Ekso GT Rehabilitation Therapy | Change in Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT) | 0.18 meters/second | Standard Deviation 0.23 |
| Group 2: Active Controls - BWSTT Therapy | Change in Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT) | 0.07 meters/second | Standard Deviation 0.11 |
| Group 3: Passive Controls | Change in Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT) | 0.03 meters/second | Standard Deviation 0.03 |
Secondary
Change in Berg Balance Scale Score From Baseline to 24 Weeks
Measurement of static and dynamic sitting and standing balance completed at baseline and at 24 weeks. Berg balance scale is a 14 item test with each item scored from 0-4. Possible scores range from 0-56. Higher scores indicate a lower risk of falls and better balance. Positive numbers indicate an improvement in Berg balance scale (scored out of 56), meaning that the participant scored higher at 24 weeks than at baseline. Negative values indicate a decline in performance of the Berg balance scale (scored out of 56), meaning that the participant scored lower at 24 weeks than at baseline.
Time frame: Baseline-24 weeks
Population: Population does not include participants who withdrew, who did not have completed outcome data, who were excluded, or who were included in the Ekso protocol run-in. Run in participants did not have data collected on them and were only utilized to to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Ekso GT Rehabilitation Therapy | Change in Berg Balance Scale Score From Baseline to 24 Weeks | 18.7 score on a scale | Standard Deviation 10.4 |
| Group 2: Active Controls - BWSTT Therapy | Change in Berg Balance Scale Score From Baseline to 24 Weeks | 19.22 score on a scale | Standard Deviation 8.4 |
| Group 3: Passive Controls | Change in Berg Balance Scale Score From Baseline to 24 Weeks | 17.3 score on a scale | Standard Deviation 6.5 |
Secondary
Change in Distance Covered Over 6 Minutes From Baseline to 24 Weeks
6 minute walk test (6MWT) completed at baseline and 24 weeks. Change assessed. Positive values indicate an increase in distance was able to be walked at 24 weeks versus at baseline. Negative values indicate a decrease in distance was walked at 24 weeks versus at baseline.
Time frame: Baseline-24 weeks
Population: Population does not include participants who withdrew, who did not have completed outcome data, who were excluded, or who were included in the Ekso protocol run-in. Run in participants did not have data collected on them and were only utilized to to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1: Ekso GT Rehabilitation Therapy | Change in Distance Covered Over 6 Minutes From Baseline to 24 Weeks | 538 feet |
| Group 2: Active Controls - BWSTT Therapy | Change in Distance Covered Over 6 Minutes From Baseline to 24 Weeks | 346.6 feet |
| Group 3: Passive Controls | Change in Distance Covered Over 6 Minutes From Baseline to 24 Weeks | 320 feet |
Secondary
Change in Time Required to Complete Timed Up and Go (TUG) Test From Baseline to 24 Week Follow up
Examined balance and walking in participants at baseline and follow up at 24 weeks. Positive values indicate an improvement of time (less time) required to complete task at 24 week follow up versus at baseline. Negative values indicate a decline, more time required to complete task at follow up versus baseline.
Time frame: Baseline and 24 weeks
Population: Population does not include participants who withdrew, who did not have completed outcome data, who were excluded, or who were included in the Ekso protocol run-in. Run in participants did not have data collected on them and were only utilized to to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1: Ekso GT Rehabilitation Therapy | Change in Time Required to Complete Timed Up and Go (TUG) Test From Baseline to 24 Week Follow up | 26.4 seconds |
| Group 2: Active Controls - BWSTT Therapy | Change in Time Required to Complete Timed Up and Go (TUG) Test From Baseline to 24 Week Follow up | 30 seconds |
| Group 3: Passive Controls | Change in Time Required to Complete Timed Up and Go (TUG) Test From Baseline to 24 Week Follow up | 46 seconds |
Secondary
Number of Participants Who Experienced a Fall During Protocol
At each training session, assessed if participant had experienced any falls. Count is number of participants who reported that yes, they did experience a fall.
Time frame: Throughout 24 weeks
Population: Population does not include participants who withdrew, who did not have completed outcome data, who were excluded, or who were included in the Ekso protocol run-in. Run in participants did not have data collected on them and were only utilized to to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ekso GT Rehabilitation Therapy | Number of Participants Who Experienced a Fall During Protocol | 0 Participants |
| Group 2: Active Controls - BWSTT Therapy | Number of Participants Who Experienced a Fall During Protocol | 0 Participants |
| Group 3: Passive Controls | Number of Participants Who Experienced a Fall During Protocol | 0 Participants |
Secondary
Number of Participants Who Met the Minimal Clinically Important Difference of 0.15m/s in Gait Speed Per 10 Meter Walk Test (10MWT) From Baseline to 24 Weeks
Number of participants who achieve the Minimal Clinically Important Difference (MCID) of 0.15 m/s during the 10MWT when comparing between baseline gait speed and gait speed at 24 weeks.
Time frame: Between baseline and 24 weeks
Population: Population does not include participants who withdrew, who did not have completed outcome data, who were excluded, or who were included in the Ekso protocol run-in. Run in participants did not have data collected on them and were only utilized to to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ekso GT Rehabilitation Therapy | Number of Participants Who Met the Minimal Clinically Important Difference of 0.15m/s in Gait Speed Per 10 Meter Walk Test (10MWT) From Baseline to 24 Weeks | 3 Participants |
| Group 2: Active Controls - BWSTT Therapy | Number of Participants Who Met the Minimal Clinically Important Difference of 0.15m/s in Gait Speed Per 10 Meter Walk Test (10MWT) From Baseline to 24 Weeks | 2 Participants |
| Group 3: Passive Controls | Number of Participants Who Met the Minimal Clinically Important Difference of 0.15m/s in Gait Speed Per 10 Meter Walk Test (10MWT) From Baseline to 24 Weeks | 0 Participants |