Status:
COMPLETED
Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Spinal Cord Injuries
Inpatients
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To assess how safe the exoskeleton, EksoGT, is to use for acute inpatient rehabilitation, if it helps people to walk better than with traditional walking training methods, or if they have any other ef...
Detailed Description
Wearable robots that assist with walking over ground are now available in rehabilitation centers. However, the study team did not know how soon it is safe to start using these devices for rehabilitati...
Eligibility Criteria
Inclusion
- 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)
- Near Normal range of motion (ROM), as follows:
- 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
- Uncontrolled cardiovascular conditions (i.e. heart failure, angina, hypertension)
- Inability to stand upright due to orthostatic hypotension
- 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
- 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
Key Trial Info
Start Date :
August 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04013997
Start Date
August 11 2017
End Date
June 12 2018
Last Update
July 10 2019
Active Locations (1)
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1
The Mount Sinai Hospital
New York, New York, United States, 10029