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| Name | Class |
|---|---|
| The Industrial Technology Research Institute | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exoskeleton robot training group | Experimental | subjects will receive exoskeleton robot training for 20 sessions (1 hr/session). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exoskeleton robot training | Device | subjects will learn to independently use the exoskeleton robot to perform functional activities (including stand-up, sit-down, stepping forward, and walking). |
| Measure | Description | Time Frame |
|---|---|---|
| 10 meters walking test | Subjects walk with exoskeleton for 10 metres, with the time measured for the intermediate 6 metres to allow for acceleration and deceleration. | Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session) |
| Measure | Description | Time Frame |
|---|---|---|
| timed up-and-go test | Record the time needed to perform timed up-and-go test wearing exoskeleton robot | Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session) |
| 6-minutes walking test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun-An Tsai, MD | 0938-592-575 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Venterans General Hospital | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1991946 | Background | Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x. | |
| 15706542 | Background | van Hedel HJ, Wirz M, Dietz V. Assessing walking ability in subjects with spinal cord injury: validity and reliability of 3 walking tests. Arch Phys Med Rehabil. 2005 Feb;86(2):190-6. doi: 10.1016/j.apmr.2004.02.010. |
| Label | URL |
|---|---|
| World Health Organization | View source |
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AIS A-D SCI patients with injury level C7-L5
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|
Record the distance covered to perform 6-min walk test wearing exoskeleton robot. Rate of Perceived Exertion will be recorded at the end of the 6-min walk test to evaluate users' endurance. |
| Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session) |
| 10414771 | Background | Harada ND, Chiu V, Stewart AL. Mobility-related function in older adults: assessment with a 6-minute walk test. Arch Phys Med Rehabil. 1999 Jul;80(7):837-41. doi: 10.1016/s0003-9993(99)90236-8. |
| foundation of spinal cord injury, R.O.C | View source |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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