NCT04221373

Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation

Completed NA Results posted Last updated 26 December 2023

What this trial tests

NA trial testing Ekso™ powered exoskeleton in Spinal Cord Injuries in 32 participants. Completed in 13 September 2022.

Timeline

30 September 2019

Primary endpoint
13 September 2022

13 September 2022

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	32
Start date	30 September 2019
Primary completion	13 September 2022
Estimated completion	13 September 2022
Sites	1 location across United States

Drugs / interventions tested

• Ekso™ powered exoskeleton
• Standard of care

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Inpatient — all drugs for Inpatient →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

18 and older, any sex, with Spinal Cord Injuries or Inpatient. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Spinal Cord Independence Measure (SCIM) Version III Scores Primary · 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)

Total score, baseline

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	18.6	± 6.4
Standard of Care Group	27.0	± 12.3

Total score before discharge, 2-3 weeks

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	54.5	± 13.8
Standard of Care Group	50.0	± 20.0

Self-care subscore, baseline

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	5.5	± 4.7
Standard of Care Group	7.2	± 3.9

Self-care subscore, before discharge, 2-3 weeks

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	14.1	± 4.9
Standard of Care Group	12.6	± 6.9

R&S management subscore, baseline

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	11.4	± 2.7
Standard of Care Group	18.2	± 8.0

R&S management subscore before discharge, 2-3 weeks

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	26.3	± 6.6
Standard of Care Group	25.6	± 8.1

Mobility subscore, baseline

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	1.7	± 2.4
Standard of Care Group	1.7	± 2.9

Mobility subscore, before discharge, 2-3 weeks

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	14.2	± 4.7
Standard of Care Group	11.8	± 6.9

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

Lower extremity motor score (LEMS), baseline

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	8.8	± 9.3
Standard of Care Group	10.7	± 9.8

LEMS, before discharge, 2-3 weeks

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	24.2	± 12.4
Standard of Care Group	17.0	± 11.6

Upper extremity motor score, before discharge, baseline

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	35.8	± 15.9
Standard of Care Group	40.3	± 14.6

UEMS, before discharge, 2-3 weeks

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	42.6	± 9.9
Standard of Care Group	42.3	± 12.4

Total Motor Score (TMS), baseline

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	44.6	± 17.5
Standard of Care Group	51.0	± 16.5

TMS before discharge, 2-3 weeks

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	66.8	± 13.1
Standard of Care Group	59.3	± 15.1

TLTS, baseline

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	78.5	± 15.5
Standard of Care Group	80.8	± 24.6

TLTS, before discharge, 2-3 weeks

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	90.0	± 16.9
Standard of Care Group	80.2	± 27.6

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

Average worst pain intensity

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	4.9	± 3.6
Standard of Care Group	3.7	± 4.4

Worst pain interference with day-to-day activities

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	2.4	± 3.9
Standard of Care Group	2.0	± 5.3

Worst pain interference with overall mood

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	3.6	± 4.7
Standard of Care Group	2.7	± 6.2

Worst pain interference with sleep

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	3.5	± 4.0
Standard of Care Group	3.4	± 5.5

Number of Participants With Neuropathic Pain Secondary · 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.

Baseline

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	3
Standard of Care Group	4

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

Group	Value	95% CI
Exoskeletal-assisted Walking Training Group	1
Standard of Care Group	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Average 2-3 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Exoskeletal-assisted Walking Training Group

Serious: 0/16 (0%)

Deaths: 0/16

Standard of Care Group

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (4 terms — click to expand)

Reaction	System	Exoskeletal-assisted Walki…	Standard of Care Group
device malfunction-related events	Product Issues	—	—
right trochanteric bursitis	Musculoskeletal and connective tissue disorders	—	—
severe Orthostatic Hypotension	Nervous system disorders	—	—
left-hand numbness	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT04221373 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exoskeletal-Assisted Walking During Acute Inpatient Rehabilitation Enhances Recovery for Persons with Spinal Cord Injury-A Pilot Randomized Controlled Trial.
   Tsai CY, Weinrauch WJ, Manente N, Huang V, et al · · 2024 · cited 5× · PMID 38661533 · DOI 10.1089/neu.2023.0667
2. Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
   Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710