Spinal Cord Injuries Clinical Trial
Official title:
Clinical Research for Exoskeleton Robot
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.
Individuals with SCI who meet the inclusion criteria will be referred to the investigators.
Participants will be given consent forms and explained the research before participating. The
participants must pass the initial evaluation described below in order to go through robot
training: (1) medical history, (2) bone density, (3) joint range of motion, ROM (4) strength
(manual muscle test, MMT), (5) muscle tone (modified Ashworth scale, MAS).
The training program consists of 5-min preparation, 50-min of functional activities training
including weight shifting, sit-down, stand-up, stepping and walking, and 5-min training
feedback. Every participant will receive at least 20 training sessions (1 hour per session,
2-5 sessions per week) and an post-training evaluation after completion of training. The
post-training evaluation includes the following tests: timed up-and-go test, 10-meter walk
test, and 6-minute walk test.
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