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Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation

NCT ID: NCT04221373

Last Updated: 2023-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2022-09-13

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.

Conditions

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Spinal Cord Injuries Inpatient

Keywords

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Rehabilitation Walking Exoskeletons

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessors are not part of intervention. They will not know which group participants will be in.

Study Groups

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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).

Group Type EXPERIMENTAL

Ekso™ powered exoskeleton

Intervention Type DEVICE

Powered exoskeletal-assisted walking (EAW) for early training

Standard of care

Intervention Type OTHER

Participants will receive standard of care of acute inpatient rehabilitation.

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.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

Participants will receive standard of care of acute inpatient rehabilitation.

Interventions

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Ekso™ powered exoskeleton

Powered exoskeletal-assisted walking (EAW) for early training

Intervention Type DEVICE

Standard of care

Participants will receive standard of care of acute inpatient rehabilitation.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York State Department of Health

OTHER_GOV

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Ann M. Spungen EdD

Vice Chairperson of Research, Department of Rehabilitation and Human Performance

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ann M. Spungen, Ed.D.

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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The Mount Sinai Hospital

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26364280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26364279 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29105657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19086708 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38661533 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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DOH01-C34722GG-3450000

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GCO 18-1632

Identifier Type: -

Identifier Source: org_study_id