N/A
N=32
Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation
Spinal Cord Injuries · Inpatient
Bottom Line
View on ClinicalTrials.gov: NCT04221373 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Change in Spinal Cord Independence Measure (SCIM) Version III Scores — 18.6; 27.0; 54.5; 50.0 score on a scale — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ekso™ powered exoskeleton (Device); Standard of care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Spinal Cord Independence Measure (SCIM) Version III Scores |
18.6; 27.0; 54.5; 50.0; 5.5; 7.2 | <0.01 sig |
| SECONDARY Change in International Standards for Neurological Classification of SCI (ISNCSCI) |
8.8; 10.7; 24.2; 17.0; 35.8; 40.3 | 0.02 sig |
| SECONDARY Change in International Spinal Cord Injury Basic Pain Data Set (ISCIBPDS) 2.0 |
4.9; 3.7; 2.4; 2.0; 3.6; 2.7 | 0.485 |
| SECONDARY Number of Participants With Neuropathic Pain |
3; 4; 1; 1 | 0.554 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04221373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.