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Completed

NCT Number: NCT04221373

Exoskeletal-Assisted Walking in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Mount Sinai Hospital

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ekso™ powered exoskeleton

Device

Powered exoskeletal-assisted walking (EAW) for early training

Standard of care

Other

Participants will receive standard of care of acute inpatient rehabilitation.

Primary outcomes

  1. Change in Spinal Cord Independence Measure (SCIM) Version III Scores

    Time frame: Baseline and before discharge from acute inpatient rehabilitation (average 2-3 weeks)

    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)

Secondary outcomes

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

    Time frame: Baseline and before discharge from acute inpatient rehabilitation (average 2-3 weeks)

    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.

  2. Change in International Spinal Cord Injury Basic Pain Data Set (ISCIBPDS) 2.0

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

    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.

  3. Number of Participants With Neuropathic Pain

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

    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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • New York State Department of Health

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 9, 2020
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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