Trial Outcomes & Findings for Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation (NCT NCT04221373)
NCT ID: NCT04221373
Last Updated: 2023-12-26
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Baseline and before discharge from acute inpatient rehabilitation (average 2-3 weeks)
Results posted on
2023-12-26
Participant Flow
Participant milestones
| Measure |
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).
Ekso™ powered exoskeleton: Powered exoskeletal-assisted walking (EAW) for early training
Standard of care: 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.
Standard of care: Participants will receive standard of care of acute inpatient rehabilitation.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
12
|
|
Overall Study
COMPLETED
|
16
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
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).
Ekso™ powered exoskeleton: Powered exoskeletal-assisted walking (EAW) for early training
Standard of care: 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.
Standard of care: Participants will receive standard of care of acute inpatient rehabilitation.
|
|---|---|---|
|
Overall Study
Physician Decision
|
4
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Exoskeletal-assisted Walking Training Group
n=16 Participants
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).
Ekso™ powered exoskeleton: Powered exoskeletal-assisted walking (EAW) for early training
Standard of care: Participants will receive standard of care of acute inpatient rehabilitation.
|
Standard of Care Group
n=12 Participants
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.
Standard of care: Participants will receive standard of care of acute inpatient rehabilitation.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 18.3 • n=16 Participants
|
46.8 years
STANDARD_DEVIATION 18.3 • n=12 Participants
|
46.3 years
STANDARD_DEVIATION 18.0 • n=28 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=16 Participants
|
3 Participants
n=12 Participants
|
9 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=16 Participants
|
9 Participants
n=12 Participants
|
19 Participants
n=28 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Etiology
traumatic
|
13 Participants
n=16 Participants
|
9 Participants
n=12 Participants
|
22 Participants
n=28 Participants
|
|
Etiology
non-traumatic
|
3 Participants
n=16 Participants
|
3 Participants
n=12 Participants
|
6 Participants
n=28 Participants
|
|
Neurological Level of Injury (NLI)
cervical
|
7 Participants
n=16 Participants
|
5 Participants
n=12 Participants
|
12 Participants
n=28 Participants
|
|
Neurological Level of Injury (NLI)
thoracic
|
5 Participants
n=16 Participants
|
4 Participants
n=12 Participants
|
9 Participants
n=28 Participants
|
|
Neurological Level of Injury (NLI)
lumbar
|
4 Participants
n=16 Participants
|
3 Participants
n=12 Participants
|
7 Participants
n=28 Participants
|
|
ASIA Impairment Scale (AIS)
A - Complete
|
3 Participants
n=16 Participants
|
4 Participants
n=12 Participants
|
7 Participants
n=28 Participants
|
|
ASIA Impairment Scale (AIS)
B - Sensory Incomplete
|
4 Participants
n=16 Participants
|
2 Participants
n=12 Participants
|
6 Participants
n=28 Participants
|
|
ASIA Impairment Scale (AIS)
C - Motor Incomplete
|
9 Participants
n=16 Participants
|
6 Participants
n=12 Participants
|
15 Participants
n=28 Participants
|
|
Inpatient Stay Days
|
51.6 days
STANDARD_DEVIATION 18.7 • n=16 Participants
|
41.8 days
STANDARD_DEVIATION 21.0 • n=12 Participants
|
47.4 days
STANDARD_DEVIATION 19.9 • n=28 Participants
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Exoskeletal-assisted Walking Training Group
n=16 Participants
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).
Ekso™ powered exoskeleton: Powered exoskeletal-assisted walking (EAW) for early training
Standard of care: Participants will receive standard of care of acute inpatient rehabilitation.
|
Standard of Care Group
n=12 Participants
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.
Standard of care: Participants will receive standard of care of acute inpatient rehabilitation.
|
|---|---|---|
|
Change in Spinal Cord Independence Measure (SCIM) Version III Scores
Total score, baseline
|
18.6 score on a scale
Standard Deviation 6.4
|
27.0 score on a scale
Standard Deviation 12.3
|
|
Change in Spinal Cord Independence Measure (SCIM) Version III Scores
Total score before discharge, 2-3 weeks
|
54.5 score on a scale
Standard Deviation 13.8
|
50.0 score on a scale
Standard Deviation 20.0
|
|
Change in Spinal Cord Independence Measure (SCIM) Version III Scores
Self-care subscore, baseline
|
5.5 score on a scale
Standard Deviation 4.7
|
7.2 score on a scale
Standard Deviation 3.9
|
|
Change in Spinal Cord Independence Measure (SCIM) Version III Scores
Self-care subscore, before discharge, 2-3 weeks
|
14.1 score on a scale
Standard Deviation 4.9
|
12.6 score on a scale
Standard Deviation 6.9
|
|
Change in Spinal Cord Independence Measure (SCIM) Version III Scores
R&S management subscore, baseline
|
11.4 score on a scale
Standard Deviation 2.7
|
18.2 score on a scale
Standard Deviation 8.0
|
|
Change in Spinal Cord Independence Measure (SCIM) Version III Scores
R&S management subscore before discharge, 2-3 weeks
|
26.3 score on a scale
Standard Deviation 6.6
|
25.6 score on a scale
Standard Deviation 8.1
|
|
Change in Spinal Cord Independence Measure (SCIM) Version III Scores
Mobility subscore, baseline
|
1.7 score on a scale
Standard Deviation 2.4
|
1.7 score on a scale
Standard Deviation 2.9
|
|
Change in Spinal Cord Independence Measure (SCIM) Version III Scores
Mobility subscore, before discharge, 2-3 weeks
|
14.2 score on a scale
Standard Deviation 4.7
|
11.8 score on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Baseline and before discharge from acute inpatient rehabilitation (average 2-3 weeks)Population: Some participants had missing data because they rejected conducting the full ISNCSCI sensory test.
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.
Outcome measures
| Measure |
Exoskeletal-assisted Walking Training Group
n=16 Participants
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).
Ekso™ powered exoskeleton: Powered exoskeletal-assisted walking (EAW) for early training
Standard of care: Participants will receive standard of care of acute inpatient rehabilitation.
|
Standard of Care Group
n=12 Participants
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.
Standard of care: Participants will receive standard of care of acute inpatient rehabilitation.
|
|---|---|---|
|
Change in International Standards for Neurological Classification of SCI (ISNCSCI)
Lower extremity motor score (LEMS), baseline
|
8.8 score on a scale
Standard Deviation 9.3
|
10.7 score on a scale
Standard Deviation 9.8
|
|
Change in International Standards for Neurological Classification of SCI (ISNCSCI)
LEMS, before discharge, 2-3 weeks
|
24.2 score on a scale
Standard Deviation 12.4
|
17.0 score on a scale
Standard Deviation 11.6
|
|
Change in International Standards for Neurological Classification of SCI (ISNCSCI)
Upper extremity motor score, before discharge, baseline
|
35.8 score on a scale
Standard Deviation 15.9
|
40.3 score on a scale
Standard Deviation 14.6
|
|
Change in International Standards for Neurological Classification of SCI (ISNCSCI)
UEMS, before discharge, 2-3 weeks
|
42.6 score on a scale
Standard Deviation 9.9
|
42.3 score on a scale
Standard Deviation 12.4
|
|
Change in International Standards for Neurological Classification of SCI (ISNCSCI)
Total Motor Score (TMS), baseline
|
44.6 score on a scale
Standard Deviation 17.5
|
51.0 score on a scale
Standard Deviation 16.5
|
|
Change in International Standards for Neurological Classification of SCI (ISNCSCI)
TMS before discharge, 2-3 weeks
|
66.8 score on a scale
Standard Deviation 13.1
|
59.3 score on a scale
Standard Deviation 15.1
|
|
Change in International Standards for Neurological Classification of SCI (ISNCSCI)
TLTS, baseline
|
78.5 score on a scale
Standard Deviation 15.5
|
80.8 score on a scale
Standard Deviation 24.6
|
|
Change in International Standards for Neurological Classification of SCI (ISNCSCI)
TLTS, before discharge, 2-3 weeks
|
90.0 score on a scale
Standard Deviation 16.9
|
80.2 score on a scale
Standard Deviation 27.6
|
|
Change in International Standards for Neurological Classification of SCI (ISNCSCI)
TPPS, baseline
|
70.0 score on a scale
Standard Deviation 23.9
|
72.7 score on a scale
Standard Deviation 30.1
|
|
Change in International Standards for Neurological Classification of SCI (ISNCSCI)
TPPS, before discharge, 2-3 weeks
|
84.5 score on a scale
Standard Deviation 16.6
|
76.3 score on a scale
Standard Deviation 30.4
|
|
Change in International Standards for Neurological Classification of SCI (ISNCSCI)
TSS, baseline
|
144.0 score on a scale
Standard Deviation 37.1
|
151.4 score on a scale
Standard Deviation 56.1
|
|
Change in International Standards for Neurological Classification of SCI (ISNCSCI)
TSS, before discharge, 2-3 weeks
|
170.1 score on a scale
Standard Deviation 32.5
|
155.1 score on a scale
Standard Deviation 60.4
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Exoskeletal-assisted Walking Training Group
n=16 Participants
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).
Ekso™ powered exoskeleton: Powered exoskeletal-assisted walking (EAW) for early training
Standard of care: Participants will receive standard of care of acute inpatient rehabilitation.
|
Standard of Care Group
n=12 Participants
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.
Standard of care: Participants will receive standard of care of acute inpatient rehabilitation.
|
|---|---|---|
|
Change in International Spinal Cord Injury Basic Pain Data Set (ISCIBPDS) 2.0
Average worst pain intensity
|
4.9 score on a scale
Standard Deviation 3.6
|
3.7 score on a scale
Standard Deviation 4.4
|
|
Change in International Spinal Cord Injury Basic Pain Data Set (ISCIBPDS) 2.0
Worst pain interference with day-to-day activities
|
2.4 score on a scale
Standard Deviation 3.9
|
2.0 score on a scale
Standard Deviation 5.3
|
|
Change in International Spinal Cord Injury Basic Pain Data Set (ISCIBPDS) 2.0
Worst pain interference with overall mood
|
3.6 score on a scale
Standard Deviation 4.7
|
2.7 score on a scale
Standard Deviation 6.2
|
|
Change in International Spinal Cord Injury Basic Pain Data Set (ISCIBPDS) 2.0
Worst pain interference with sleep
|
3.5 score on a scale
Standard Deviation 4.0
|
3.4 score on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Exoskeletal-assisted Walking Training Group
n=12 Participants
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).
Ekso™ powered exoskeleton: Powered exoskeletal-assisted walking (EAW) for early training
Standard of care: Participants will receive standard of care of acute inpatient rehabilitation.
|
Standard of Care Group
n=11 Participants
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.
Standard of care: Participants will receive standard of care of acute inpatient rehabilitation.
|
|---|---|---|
|
Number of Participants With Neuropathic Pain
Baseline
|
3 Participants
|
4 Participants
|
|
Number of Participants With Neuropathic Pain
discharge from acute inpatient rehabilitation (average 2-3 weeks)
|
1 Participants
|
1 Participants
|
Adverse Events
Exoskeletal-assisted Walking Training Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Standard of Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exoskeletal-assisted Walking Training Group
n=16 participants at risk
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).
Ekso™ powered exoskeleton: Powered exoskeletal-assisted walking (EAW) for early training
Standard of care: Participants will receive standard of care of acute inpatient rehabilitation.
|
Standard of Care Group
n=12 participants at risk
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.
Standard of care: Participants will receive standard of care of acute inpatient rehabilitation.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
right trochanteric bursitis
|
6.2%
1/16 • Average 2-3 weeks
|
0.00%
0/12 • Average 2-3 weeks
|
|
Nervous system disorders
severe Orthostatic Hypotension
|
6.2%
1/16 • Average 2-3 weeks
|
0.00%
0/12 • Average 2-3 weeks
|
|
Nervous system disorders
left-hand numbness
|
6.2%
1/16 • Average 2-3 weeks
|
0.00%
0/12 • Average 2-3 weeks
|
|
Product Issues
device malfunction-related events
|
12.5%
2/16 • Average 2-3 weeks
|
0.00%
0/12 • Average 2-3 weeks
|
Additional Information
Dr. Chung-Ying Tsai
Icahn School of Medicine at Mount Sinai
Phone: (212) 241-7073
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place