Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Inpatient
• Intervention / Treatment: Device: Ekso™ powered exoskeleton; Other: Standard of care

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chung-Ying Tsai, PT, PhD; Phone Number: 212-241-7073; Email: chung-ying.tsai@mountsinai.org
• Study Contact Backup: Name: Andrew Delgado, MS; Phone Number: 212-241-9478; Email: andrew.delgado@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: New York State Department of Health
• Investigators: Principal Investigator: Ann M. Spungen, Ed.D., Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): September 13, 2022
• Study Completion (Actual): September 13, 2022

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Walking; Exoskeletons
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: GCO 18-1632; DOH01-C34722GG-3450000 (Other Grant/Funding Number: Department of Health, State of New York)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes