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| ID | Type | Description | Link |
|---|---|---|---|
| DOH01-C34722GG-3450000 | Other Grant/Funding Number | Department of Health, State of New York |
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| Name | Class |
|---|---|
| New York State Department of Health | OTHER_GOV |
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The purpose of this research study is to test the effect of early exoskeletal-assisted walking (EAW) training (combined into regular acute inpatient rehabilitation (AIR)) on improving functional recovery and reducing pain and inflammation. Powered exoskeletons are a technology that offer standing and walking for certain persons with spinal cord injury (SCI) who meet the using indication of the device and have been used in the chronic SCI population with positive benefits in ability to move, daily function (such as bathing and dressing), body composition (such as lean and fat tissue mass), and quality of life (QOL). Despite the potential for EAW to promote functional recovery and reduce secondary medical complications (such as urinary tract infections and pain), no reports exist on the use of exoskeletons in AIR.
People with spinal cord injury (SCI) can have an abrupt loss of upright mobility, function and physical activity. Inflammation and pain are reported to be increased, with negative impacts on quality of life. Powered exoskeletons are a technology that offer standing and walking for eligible persons with SCI and have predominantly been used in the chronic SCI population with positive benefits in mobility, function, body composition, and quality of life (QOL). Despite the potential for exoskeletal-assisted walking (EAW) to promote functional recovery and mitigate secondary medical complications, no reports exist on the use of exoskeletons in acute inpatient rehabilitation (AIR). The goal of this study is to test the effect of early EAW training (incorporated into regular AIR) on accelerating functional recovery and reducing pain and inflammation. A total of 30 people with non-progressive SCI (≥18 years; <6 months after SCI), who are clinically eligible for gait training during AIR, will be randomly assigned into one of two groups (15 participants/group, stratified evenly for traumatic and non-traumatic SCI). The intervention group will receive gait training with an Ekso powered exoskeleton, incorporated into usual 3-hour AIR (AIR with EAW group). The control group will have usual 3-hour AIR, but without using an exoskeleton (AIR only group). Motor function, functional activities, pain and inflammation will be assessed after enrollment in the study and before discharge from AIR. The intervention group is expected to have significantly better outcomes compared with the control group. The impact of successful completion of this study would increase knowledge of the effect of using EAW during acute/subacute AIR. The expected outcome of this study is that exoskeletal-assisted walking during AIR will have significantly greater effects on mitigating some of the secondary consequences of paralysis from SCI during the early phases of recovery and rehabilitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exoskeletal-assisted walking training group | Experimental | Participants will receive locomotor training provided with an Ekso™ powered exoskeleton according to the standard of care of AIR at Mount Sinai Hospital with the exception that the EAW training will be incorporated into the designated therapy times (3 hours of physical therapy (PT) and/or occupational therapy (OT)) which will be provided as determined by the clinical team from the earliest time they are identified to be able to safely stand, through discharge. The goal of EAW intervention is to complete three or more sessions of EAW training a week during the AIR period (after enrolling into the study until discharge). |
|
| Standard of care group | Active Comparator | Participants will receive standard of care of acute inpatient rehabilitation which includes three hours of physical therapy and/or occupational therapy per day until they are discharged. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ekso™ powered exoskeleton | Device | Powered exoskeletal-assisted walking (EAW) for early training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spinal Cord Independence Measure (SCIM) Version III Scores | Functional activities will be assessed using Spinal Cord Independence Measure (SCIM) scores evaluated by clinicians. Full Scale range from 0-100, higher score indicates more independence. Each subscale score is evaluated within the 100-point scale (self-care: 0-20; respiration and sphincter (R & S) management: 0-40; mobility: 0-40) | Baseline and before discharge from acute inpatient rehabilitation (average 2-3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Standards for Neurological Classification of SCI (ISNCSCI) | Motor and sensory function was assessed by a physiatrist using the International Standards 152 for Neurological Classification of Spinal Cord Injury (ISNCSCI) to determine a total motor score (TMS, ranges from 0 to 100), upper extremity motor score (UEMS, ranges from 0 to 50), lower extremity motor score (LEMS, ranges from 0 to 50), total light touch score (TLTS, ranges from 0 to 112), total pin prick score (TPPS, ranges from 0 to 112), and total sensory score (TSS, ranges from 0 to 224). Higher score indicates better function. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ann M. Spungen, Ed.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 26364279 | Background | Yang A, Asselin P, Knezevic S, Kornfeld S, Spungen AM. Assessment of In-Hospital Walking Velocity and Level of Assistance in a Powered Exoskeleton in Persons with Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):100-9. doi: 10.1310/sci2102-100. Epub 2015 Apr 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exoskeletal-assisted Walking Training Group | Participants will receive locomotor training provided with an Ekso™ powered exoskeleton according to the standard of care of AIR at Mount Sinai Hospital with the exception that the EAW training will be incorporated into the designated therapy times (3 hours of physical therapy (PT) and/or occupational therapy (OT)) which will be provided as determined by the clinical team from the earliest time they are identified to be able to safely stand, through discharge. The goal of EAW intervention is to complete three or more sessions of EAW training a week during the AIR period (after enrolling into the study until discharge). Ekso™ powered exoskeleton: Powered exoskeletal-assisted walking (EAW) for early training Standard of care: Participants will receive standard of care of acute inpatient rehabilitation. |
| FG001 | Standard of Care Group | Participants will receive standard of care of acute inpatient rehabilitation which includes three hours of physical therapy and/or occupational therapy per day until they are discharged. Standard of care: Participants will receive standard of care of acute inpatient rehabilitation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exoskeletal-assisted Walking Training Group | Participants will receive locomotor training provided with an Ekso™ powered exoskeleton according to the standard of care of AIR at Mount Sinai Hospital with the exception that the EAW training will be incorporated into the designated therapy times (3 hours of physical therapy (PT) and/or occupational therapy (OT)) which will be provided as determined by the clinical team from the earliest time they are identified to be able to safely stand, through discharge. The goal of EAW intervention is to complete three or more sessions of EAW training a week during the AIR period (after enrolling into the study until discharge). Ekso™ powered exoskeleton: Powered exoskeletal-assisted walking (EAW) for early training Standard of care: Participants will receive standard of care of acute inpatient rehabilitation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Spinal Cord Independence Measure (SCIM) Version III Scores | Functional activities will be assessed using Spinal Cord Independence Measure (SCIM) scores evaluated by clinicians. Full Scale range from 0-100, higher score indicates more independence. Each subscale score is evaluated within the 100-point scale (self-care: 0-20; respiration and sphincter (R & S) management: 0-40; mobility: 0-40) | Posted | Mean | Standard Deviation | score on a scale | Baseline and before discharge from acute inpatient rehabilitation (average 2-3 weeks) |
|
Average 2-3 weeks
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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 | Exoskeletal-assisted Walking Training Group | Participants will receive locomotor training provided with an Ekso™ powered exoskeleton according to the standard of care of AIR at Mount Sinai Hospital with the exception that the EAW training will be incorporated into the designated therapy times (3 hours of physical therapy (PT) and/or occupational therapy (OT)) which will be provided as determined by the clinical team from the earliest time they are identified to be able to safely stand, through discharge. The goal of EAW intervention is to complete three or more sessions of EAW training a week during the AIR period (after enrolling into the study until discharge). Ekso™ powered exoskeleton: Powered exoskeletal-assisted walking (EAW) for early training Standard of care: Participants will receive standard of care of acute inpatient rehabilitation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| right trochanteric bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Small sample size and potential selection bias due to the lack of a prospectively randomized comparison group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chung-Ying Tsai | Icahn School of Medicine at Mount Sinai | (212) 241-7073 | chung-ying.tsai@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2023 | Aug 29, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 10, 2022 | Dec 21, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord 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 |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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A two-group, single blinded (raters are not part of intervention) and randomized clinical trial (RCT) with stratification for traumatic or non-traumatic injury will be performed. A total of 30 people with non-progressive SCI, who are over 18 years and eligible for locomotor training as part of acute inpatient rehabilitation (AIR) will be randomized. We expect to recruit, consent, and screen 40 people to accommodate a 25% drop-out rate due to unpredictability during inpatient stay for a target sample of 30 participants to complete the protocol. Eligible participants will be randomized into either the intervention group or the control group. Each group will have 15 participants stratified for 7 having traumatic and 8 having non-traumatic etiologies
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The outcome assessors are not part of intervention. They will not know which group participants will be in.
| Standard of care | Other | Participants will receive standard of care of acute inpatient rehabilitation. |
|
| Baseline and before discharge from acute inpatient rehabilitation (average 2-3 weeks) |
| Change in International Spinal Cord Injury Basic Pain Data Set (ISCIBPDS) 2.0 | Change in International Spinal Cord Injury Basic Pain Data Set (ISCIBPDS) 2.0 contains critical questions about clinically relevant information concerning SCI-related pain during the last 7 days, including pain intensity, the influence of pain on daily activities, mood, and sleep between admission and discharge. Full scale from 0-10, higher score indicates more pain. | Baseline and at discharge from acute inpatient rehabilitation (average 2-3 weeks) |
| Number of Participants With Neuropathic Pain | Number of participants with neuropathic pain as measured by the Spinal Cord Injury Pain Instrument (SCIPI). Spinal Cord Injury Pain Instrument (SCIPI) is a tool used to classify pain after SCI using 4 questions. It can be easily used by clinicians in every clinical setting to identify the pain classifications, including neuropathic, nociceptive, neither or unknown. Full scale from 0 to 4, a score of 1 or more than 1 indicates probable neuropathic pain. | Baseline and discharge from acute inpatient rehabilitation (average 2-3 weeks) |
| 29105657 | Background | Bach Baunsgaard C, Vig Nissen U, Katrin Brust A, Frotzler A, Ribeill C, Kalke YB, Leon N, Gomez B, Samuelsson K, Antepohl W, Holmstrom U, Marklund N, Glott T, Opheim A, Benito J, Murillo N, Nachtegaal J, Faber W, Biering-Sorensen F. Gait training after spinal cord injury: safety, feasibility and gait function following 8 weeks of training with the exoskeletons from Ekso Bionics. Spinal Cord. 2018 Feb;56(2):106-116. doi: 10.1038/s41393-017-0013-7. Epub 2017 Nov 6. |
| 19086708 | Background | Forrest GF, Sisto SA, Barbeau H, Kirshblum SC, Wilen J, Bond Q, Bentson S, Asselin P, Cirnigliaro CM, Harkema S. Neuromotor and musculoskeletal responses to locomotor training for an individual with chronic motor complete AIS-B spinal cord injury. J Spinal Cord Med. 2008;31(5):509-21. doi: 10.1080/10790268.2008.11753646. |
| 38661533 | Derived | Tsai CY, Weinrauch WJ, Manente N, Huang V, Bryce TN, Spungen AM. Exoskeletal-Assisted Walking During Acute Inpatient Rehabilitation Enhances Recovery for Persons with Spinal Cord Injury-A Pilot Randomized Controlled Trial. J Neurotrauma. 2024 Sep;41(17-18):2089-2100. doi: 10.1089/neu.2023.0667. Epub 2024 May 8. |
| BG001 | Standard of Care Group | Participants will receive standard of care of acute inpatient rehabilitation which includes three hours of physical therapy and/or occupational therapy per day until they are discharged. Standard of care: Participants will receive standard of care of acute inpatient rehabilitation. |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| Etiology | Count of Participants | Participants |
|
| Neurological Level of Injury (NLI) | Count of Participants | Participants |
|
| ASIA Impairment Scale (AIS) | American Spinal Injury Association Impairment Scale (AIS): A - Complete Injury - No sensory or motor function B - Sensory Incomplete - Sensory but not motor function is preserved below the neurological level C- Motor Incomplete - Motor function is preserved below the neurological level | Count of Participants | Participants |
|
| Inpatient Stay Days | Mean | Standard Deviation | days |
|
| OG001 | Standard of Care Group | Participants will receive standard of care of acute inpatient rehabilitation which includes three hours of physical therapy and/or occupational therapy per day until they are discharged. Standard of care: Participants will receive standard of care of acute inpatient rehabilitation. |
|
|
|
| Secondary | Change in International Standards for Neurological Classification of SCI (ISNCSCI) | Motor and sensory function was assessed by a physiatrist using the International Standards 152 for Neurological Classification of Spinal Cord Injury (ISNCSCI) to determine a total motor score (TMS, ranges from 0 to 100), upper extremity motor score (UEMS, ranges from 0 to 50), lower extremity motor score (LEMS, ranges from 0 to 50), total light touch score (TLTS, ranges from 0 to 112), total pin prick score (TPPS, ranges from 0 to 112), and total sensory score (TSS, ranges from 0 to 224). Higher score indicates better function. | Some participants had missing data because they rejected conducting the full ISNCSCI sensory test. | Posted | Mean | Standard Deviation | score on a scale | Baseline and before discharge from acute inpatient rehabilitation (average 2-3 weeks) |
|
|
|
|
| Secondary | Change in International Spinal Cord Injury Basic Pain Data Set (ISCIBPDS) 2.0 | Change in International Spinal Cord Injury Basic Pain Data Set (ISCIBPDS) 2.0 contains critical questions about clinically relevant information concerning SCI-related pain during the last 7 days, including pain intensity, the influence of pain on daily activities, mood, and sleep between admission and discharge. Full scale from 0-10, higher score indicates more pain. | Posted | Mean | Standard Deviation | score on a scale | Baseline and at discharge from acute inpatient rehabilitation (average 2-3 weeks) |
|
|
|
|
| Secondary | Number of Participants With Neuropathic Pain | Number of participants with neuropathic pain as measured by the Spinal Cord Injury Pain Instrument (SCIPI). Spinal Cord Injury Pain Instrument (SCIPI) is a tool used to classify pain after SCI using 4 questions. It can be easily used by clinicians in every clinical setting to identify the pain classifications, including neuropathic, nociceptive, neither or unknown. Full scale from 0 to 4, a score of 1 or more than 1 indicates probable neuropathic pain. | Posted | Count of Participants | Participants | Baseline and discharge from acute inpatient rehabilitation (average 2-3 weeks) |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 5 |
| 16 |
| EG001 | Standard of Care Group | Participants will receive standard of care of acute inpatient rehabilitation which includes three hours of physical therapy and/or occupational therapy per day until they are discharged. Standard of care: Participants will receive standard of care of acute inpatient rehabilitation. | 0 | 12 | 0 | 12 | 0 | 12 |
| severe Orthostatic Hypotension | Nervous system disorders | Non-systematic Assessment |
|
| left-hand numbness | Nervous system disorders | Non-systematic Assessment |
|
| device malfunction-related events | Product Issues | Non-systematic Assessment |
|
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| D014947 | Wounds and Injuries |
| lumbar |
|
| C - Motor Incomplete |
|
| LEMS, before discharge, 2-3 weeks |
|
|
| Upper extremity motor score, before discharge, baseline |
|
|
| UEMS, before discharge, 2-3 weeks |
|
|
| Total Motor Score (TMS), baseline |
|
|
| TMS before discharge, 2-3 weeks |
|
|
| TLTS, baseline |
|
|
| TLTS, before discharge, 2-3 weeks |
|
|
| TPPS, baseline |
|
|
| TPPS, before discharge, 2-3 weeks |
|
|
| TSS, baseline |
|
|
| TSS, before discharge, 2-3 weeks |
|
|
LEMS
| Mixed Models Analysis |
F(1, 26) = 33.29 |
| <0.01 |
Main effect of time |
| Other |
Mixed-effects model |
| UEMS | Mixed Models Analysis | F(1,26) = 4.58 | 0.04 | Treatment group by time interaction effects | Other | Mixed-effects model |
| UEMS | Mixed Models Analysis | F(1, 26) = 15.34 | <0.01 | Main effect of time | Other | Mixed-effects model |
| TMS | Mixed Models Analysis | F(1,26) = 8.06 | <0.01 | Treatment group by time interaction effects | Other | Mixed-effects model |
| Mixed Models Analysis | F(1,26) = 38.91 | <0.01 | Main effect of time | Other | TMS |
| TLTS | Mixed Models Analysis | F(1,21.7) = 6.23 | 0.02 | Treatment group by time interaction effects | Other | Mixed-effects model |
| TLTS | Mixed Models Analysis | F(1 26)=4.14 | 0.05 | Main effect of time | Other | Mixed-effects model |
| Worst pain interference with overall mood |
|
| Worst pain interference with sleep |
|
Average worst pain intensity |
| Mixed Models Analysis |
F(1, 21) = 26.71 |
| 0.000 |
Main effect of time |
| Other |
Mixed-effects model |
| Worst pain interference with day-to-day activities | Mixed Models Analysis | F(1, 21) = 0.05 | 0.832 | Treatment group-by-time interaction effect | Other | Mixed-effects model |
| Worst pain interference with day-to-day activities | Mixed Models Analysis | F(1, 21) = 5.21 | 0.033 | Main effect of time | Other | Mixed-effects model |
| Worst pain interference with overall mood | Mixed Models Analysis | F(1, 42) = 0.16 | 0.692 | Treatment group-by-time interaction effect | Other | Mixed-effects model |
| Worst pain interference with overall mood | Mixed Models Analysis | F(1, 42) = 8.65 | 0.005 | Main effect of time | Other | Mixed-effects model |
| Worst pain interfered with sleep | Mixed Models Analysis | F(1,21) = 0.01 | 0.946 | Treatment group-by-time interaction effect | Other | Mixed-effects model |
| Worst pain interference with sleep | Mixed Models Analysis | F(1,21) = 11.94 | 0.0002 | Main effect of time | Other | Mixed-effects model |
X^2 (1, N = 23) = 0.004 |
| 0.949 |
| Superiority |