The Efficacy and Safety of a New Power Exoskeleton Robot for Improving Walking Ability in Spinal … (NCT03548649) | Clinical Trial Compass
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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 range
18 Years – 70 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)