Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation

Completed · Not applicable

Conditions studied: Spinal Cord Injuries, Inpatient

In brief

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.

Key facts

Study ID

NCT04221373

Run by

Icahn School of Medicine at Mount Sinai

People needed

32

Starts

2019-09-30

Expected to finish

2022-09-13

Last updated by the study team

2023-12-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Mount Sinai Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.