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| Name | Class |
|---|---|
| Burke Medical Research Institute | OTHER |
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Ekso GT Rehabilitation Therapy | Experimental | 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 |
|
| Group 2: Active controls - BWSTT Therapy | Active Comparator | 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 |
|
| Group 3: Passive controls | No Intervention | Participants in this group continue with normal daily activities over 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ekso GT Rehabilitation Therapy | Device | Walking Improvement for Spinal Cord Injuries with Exoskeleton |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Between baseline and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
AIS-A SCI or AIS-B SCI
Lower motor neuron injuries, as shown by absent reflexes during bilateral quadriceps and Achilles tendon taps
< 3 months since previous intensive gait training regimen
Already walking at self-selected ambulation speeds of at least 0.44 meter/second with or without assistance
Currently involved in another intervention study
Concurrent neurological disease
Hip flexion contracture greater than ~17°
Knee flexion contracture greater than 12°
Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral with max 12° knee flexion)
Leg length discrepancy
Spinal instability
Unresolved deep vein thrombosis
Uncontrolled autonomic dysreflexia
Severe muscular or skeletal pain
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.
Open skin ulcerations on buttocks or other body surfaces in contact with exoskeleton or harness
Pregnancy
Cognitive impairments - unable to follow 2 steps commands and communicate for pain or to stop session
Shoulder extension Range of Motion (ROM) < 50° excludes crutches during sit to stand or vice versa. (Walking with crutches permitted.)
Participant requires the assistance of more than one therapist to transfer safely.
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
Active heterotrophic ossification (HO), hip dysplasia or hip/knee axis abnormalities
Colostomy
History of long bone fractures since the SCI, secondary to osteoporosis
Unable to sustain current medication regimen
Any reason the physician may deem as harmful to the participant to enroll or continue in the study
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| Name | Affiliation | Role |
|---|---|---|
| Dylan Edwards, PhD | Burke Medical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute at St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27372363 | Background | Stampacchia G, Rustici A, Bigazzi S, Gerini A, Tombini T, Mazzoleni S. Walking with a powered robotic exoskeleton: Subjective experience, spasticity and pain in spinal cord injured persons. NeuroRehabilitation. 2016 Jun 27;39(2):277-83. doi: 10.3233/NRE-161358. | |
| 26736463 | Background | Gad PN, Gerasimenko YP, Zdunowski S, Sayenko D, Haakana P, Turner A, Lu D, Roy RR, Edgerton VR. Iron 'ElectriRx' man: Overground stepping in an exoskeleton combined with noninvasive spinal cord stimulation after paralysis. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:1124-7. doi: 10.1109/EMBC.2015.7318563. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 30, 2017 | Oct 5, 2023 |
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| Body Weight Supported (BWS) Treadmill Training | Device | Standard gait training using BWS PT and overground training |
|
|
| 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. | Baseline-24 weeks |
| 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. | Baseline and 24 weeks |
| 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. | Throughout 24 weeks |
| 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. | Baseline-24 weeks |
| Gaylord Hospital |
| Wallingford |
| Connecticut |
| 06492 |
| United States |
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611 | United States |
| Marianjoy Rehabilitation Hospital | Wheaton | Illinois | 60187 | United States |
| Kennedy Kruger Institute | Baltimore | Maryland | 21211 | United States |
| Rehabilitation Institute of Michigan | Detroit | Michigan | 48201 | United States |
| Courage Kenny Research Center | Minneapolis | Minnesota | 55407 | United States |
| Kessler Foundation | West Orange | New Jersey | 07052 | United States |
| Burke Medical Research Institute | White Plains | New York | 10605 | United States |
| TIRR Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| 26364280 | Background | Kozlowski AJ, Bryce TN, Dijkers MP. Time and Effort Required by Persons with Spinal Cord Injury to Learn to Use a Powered Exoskeleton for Assisted Walking. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):110-21. doi: 10.1310/sci2102-110. Epub 2015 Apr 12. |
| 24845221 | Background | Kressler J, Thomas CK, Field-Fote EC, Sanchez J, Widerstrom-Noga E, Cilien DC, Gant K, Ginnety K, Gonzalez H, Martinez A, Anderson KD, Nash MS. Understanding therapeutic benefits of overground bionic ambulation: exploratory case series in persons with chronic, complete spinal cord injury. Arch Phys Med Rehabil. 2014 Oct;95(10):1878-1887.e4. doi: 10.1016/j.apmr.2014.04.026. Epub 2014 May 17. |
| 26818847 | Background | Sale P, Russo EF, Russo M, Masiero S, Piccione F, Calabro RS, Filoni S. Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: a preliminary report. BMC Neurol. 2016 Jan 28;16:12. doi: 10.1186/s12883-016-0536-0. |
| Background | Kolakowsky-Hayner SA, Crew J, Moran S, Shah A. Safety and feasibility of using the EksoTM bionic exoskeleton to aid ambulation after spinal cord injury. Spine. 2013 doi.org/10.4172/2165-7939.S4-003 |
| 24788068 | Background | Forrest GF, Hutchinson K, Lorenz DJ, Buehner JJ, Vanhiel LR, Sisto SA, Basso DM. Are the 10 meter and 6 minute walk tests redundant in patients with spinal cord injury? PLoS One. 2014 May 1;9(5):e94108. doi: 10.1371/journal.pone.0094108. eCollection 2014. |
| 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 |
| FG002 | Group 3: Passive Controls | Participants in this group continue with normal daily activities over 12 weeks. |
| FG003 | Run-in | Panients in this group began the intervention protocol for the EksoGT group to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol. |
| COMPLETED |
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| NOT COMPLETED |
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Participants in the EksoGT run-in trial were for the learning of the therapists carrying out study protocol. While these participants were trained on the EksoGT, further data was not collected and no data was analyzed, including baseline characteristics. These numbers also do not include participants who withdrew from the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Group 3: Passive Controls | Participants in this group continue with normal daily activities over 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Age, Continuous | Mean | Full Range | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||
| Time since injury | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | meters/second | Baseline and 12 Weeks |
|
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| |||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | Between baseline and 24 weeks |
| ||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Inter-Quartile Range | feet | Baseline-24 weeks |
| |||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Inter-Quartile Range | seconds | Baseline and 24 weeks |
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| 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. | 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. | Posted | Count of Participants | Participants | Throughout 24 weeks |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline-24 weeks |
|
AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 14 | 1 | 14 | 12 | 14 |
| EG001 | 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 | 0 | 13 | 1 | 13 | 9 | 13 |
| EG002 | Group 3: Passive Controls | Participants in this group continue with normal daily activities over 12 weeks. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | Ekso Run in Participants | Participants in this group receive Ekso GT (gait training) PT therapy intervention but were not included in full data collection. This was completed to help the therapists get used to the protocol and use of the device. | 0 | 12 | 0 | 12 | 8 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
| ||
| lower extremity numbness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| allergic reaction to medication | Immune system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood pressure issues | Cardiac disorders | Systematic Assessment | Increased blood pressure resulting in treatment cessation |
| |
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Participant experienced any type of fall (from standing, from seated position) in or outside of any therapy treatment |
| |
| Illness | Infections and infestations | Systematic Assessment | Illnesses including flu, common cold, stomach virus, nausea, bronchitis, prostate infection |
| |
| Nerve pain or numbness | Nervous system disorders | Systematic Assessment |
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| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | included musculoskeletal pain, headache, and internal organ pain |
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| Planned medical or surgical procedure | Surgical and medical procedures | Systematic Assessment |
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| Skin bruising, redness, or rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Systematic Assessment | UTI |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dylan Edwards | Moss Rehabilitation Research Institute, Elkins Park, PA, USA | 215-663-6554 | dylan.edwards@jefferson.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2015 | Oct 5, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 5, 2017 | Oct 5, 2023 | ICF_002.pdf |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D000067190 | Exoskeleton Device |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| OG002 | Group 3: Passive Controls | Participants in this group continue with normal daily activities over 12 weeks. |
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| OG002 | Group 3: Passive Controls | Participants in this group continue with normal daily activities over 12 weeks. |
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| OG002 | Group 3: Passive Controls | Participants in this group continue with normal daily activities over 12 weeks. |
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| OG002 |
| Group 3: Passive Controls |
Participants in this group continue with normal daily activities over 12 weeks. |
|
|
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
| OG002 | Group 3: Passive Controls | Participants in this group continue with normal daily activities over 12 weeks. |
|
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