Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Incorporated Exoskeletal-Assisted Walking in Spinal Cord Injury (SCI) Acute Inpatient Rehabilitation

Conditions
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Spinal Cord Injuries, Inpatient

Intervention / Treatment
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* Device: Ekso™ powered exoskeleton
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Age 18 years or greater Height between 5'2 and 6'2 (1.6 meters to 1.9 meters) Weight less than 220 pounds (100 kilograms) Hip: 5 degrees of extension; 110 of flexion Knee: Full extension to 110 of flexion Ankle: at least 0 of dorsiflexion to 25 of plantarflexion Are eligible for locomotor training as part of inpatient rehabilitation Independent with static sitting balance Sufficient function upper extremity strength to manage walking aid (front-wheeled walker, platform walker, or crutches) Able to follow directions Exclusion Criteria Uncontrolled cardiovascular conditions (i.e. heart failure, angina, hypertension) Inability to stand upright due to orthostatic hypotension Any form of progressive SCI as defined by the physician, such as cancers Body characteristics that do not fit within exoskeleton limits Upper leg length discrepancy > 0.5 or lower leg discrepancy >0.75 Skin integrity issues in areas that would contact the device or that would likely be made worse by device use Pregnancy Colostomy Mechanical ventilation Non-English Speaking The participant is able to walk better with exoskeleton assistance at baseline Any other issue that might prevent safe standing or walking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exoskeletal-assisted walking training group<br>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). | Device: Ekso™ powered exoskeleton<br>* Powered exoskeletal-assisted walking (EAW) for early training<br>Other: Standard of care<br>* Participants will receive standard of care of acute inpatient rehabilitation.<br>|
| Active Comparator: Standard of care group<br>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. | Other: Standard of care<br>* Participants will receive standard of care of acute inpatient rehabilitation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exoskeletons, Rehabilitation, Walking