Clinical trial NCT04221373: Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation
Official title: The Effects of Incorporated Exoskeletal-Assisted Walking in Spinal Cord Injury (SCI) Acute Inpatient Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Inpatient
Keywords: Rehabilitation
Walking
Exoskeletons
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: New York State Department of Health
First posted: 2020-01-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Spinal Cord Independence Measure (SCIM) Version III Scores
timeFrame: Baseline and before discharge from acute inpatient rehabilitation (average 2-3 weeks)
Secondary outcomes:
measure: Change in International Standards for Neurological Classification of SCI (ISNCSCI)
timeFrame: Baseline and before discharge from acute inpatient rehabilitation (average 2-3 weeks)
measure: Change in International Spinal Cord Injury Basic Pain Data Set (ISCIBPDS) 2.0
timeFrame: Baseline and at discharge from acute inpatient rehabilitation (average 2-3 weeks)
measure: Number of Participants With Neuropathic Pain
timeFrame: Baseline and discharge from acute inpatient rehabilitation (average 2-3 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ann M. Spungen, Ed.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.