Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation

NCT04221373 | Completed Results FDA Device

• 2 other identifiers: GCO 18-1632DOH01-C34722GG-3450000
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Inpatient

Keywords

Rehabilitation; Walking; Exoskeletons

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in International Standards for Neurological Classification of SCI (ISNCSCI)

  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

  Baseline and at discharge from acute inpatient rehabilitation (average 2-3 weeks)

• Number of Participants With Neuropathic Pain

  Baseline and discharge from acute inpatient rehabilitation (average 2-3 weeks)

Study Arms (2)

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).

Device: Ekso™ powered exoskeleton; Other: Standard of care

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.

Other: Standard of care

Interventions

Ekso™ powered exoskeleton DEVICE

Powered exoskeletal-assisted walking (EAW) for early training

Exoskeletal-assisted walking training group

Standard of care OTHER

Participants will receive standard of care of acute inpatient rehabilitation.

Exoskeletal-assisted walking training group; Standard of care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• New York State Department of Health: collaborator

Study Sites (1)

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (5)

• 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.

  PMID: 26364280 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.

  PMID: 26364279 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.

  PMID: 29105657 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.

  PMID: 19086708 BACKGROUND

• 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.

  PMID: 38661533 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Small sample size and potential selection bias due to the lack of a prospectively randomized comparison group.

Results Point of Contact

• Title: Dr. Chung-Ying Tsai
• Organization: Icahn School of Medicine at Mount Sinai

chung-ying.tsai@mountsinai.org

(212) 241-7073

Study Officials

• Ann M. Spungen, Ed.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors are not part of intervention. They will not know which group participants will be in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairperson of Research, Department of Rehabilitation and Human Performance

Model Details: 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

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: September 30, 2019
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: December 26, 2023
• Results First Posted: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)