The Efficacy and Safety of a New Power Exoskeleton Robot for Improving Walking Ability in Spinal … (NCT03548649) | Clinical Trial Compass
UnknownNot Applicable
The Efficacy and Safety of a New Power Exoskeleton Robot for Improving Walking Ability in Spinal Cord Injury Patients
Taiwan60 participantsStarted 2017-08-30
Plain-language summary
In Taiwan, there are more than 23,000 individuals with spinal cord injuries (SCI, mean age: 27 years), with an increment of new 1,200 SCI individuals each year. Recovery of ambulatory function is among the most important therapeutic goals because 92% of the individuals with SCI have to use the wheelchair for the rest of their lives.
The lower limb powered exoskeleton robot, FREE Walk, used for training in this research was developed by FREE Bionics Inc. The main purpose of this research is to test the safety and feasibility of FREE Walk exoskeleton robot. In addition, the research will further investigate the range of injury levels for the intended SCI users and the learning time needed for the users to independently operate the exoskeleton robot.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Spinal cord injury patients whose injury levels range from C7 to L5, ASIA impairment scale A to D, can use forearm crutch and can't walk without an assistive device.
✓. In a stable condition, for example, at least 3 months after first injury/onset, or with stable spine, or had been corrected (internal fixation).
✓. Age between 18-70.
✓. height between 150-190cm; weight less than 100kg; thigh length between 32-47cm; leg length (from lateral epicondyle of femur to sole) between 23-59cm.
✓. Normal joint range of motion(ROM) of both lower extremities and upper extremities or ROM limitation will not affect ambulation.
✓. Can maintain trunk stability with or without hand support in sitting position for 60s.
Exclusion criteria
✕. Combine other neurological diseases, for example, stroke, cerebral palsy, Parkinson's disease,... etc.
✕. Femoral T-score \<-2.5. (Doctor's approval must be obtained for those who with femoral t-score between -2.5 and -3).
What they're measuring
1
10 meters walking test
Timeframe: Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session)