The Efficacy and Safety of a New Power Exoskeleton Robot for Improving Walking Ability in Spinal Cord Injury Patients
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|ClinicalTrials.gov Identifier: NCT03548649|
Recruitment Status : Enrolling by invitation
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries Complete Spinal Cord Injury Incomplete Spinal Cord Injury||Device: exoskeleton robot training||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||AIS A-D SCI patients with injury level C7-L5|
|Masking:||None (Open Label)|
|Official Title:||Clinical Research for Exoskeleton Robot|
|Actual Study Start Date :||August 30, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: exoskeleton robot training group
subjects will receive exoskeleton robot training for 20 sessions (1 hr/session).
Device: exoskeleton robot training
subjects will learn to independently use the exoskeleton robot to perform functional activities (including stand-up, sit-down, stepping forward, and walking).
Other Name: gait training
- 10 meters walking test [ Time Frame: Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session) ]Subjects walk with exoskeleton for 10 metres, with the time measured for the intermediate 6 metres to allow for acceleration and deceleration.
- timed up-and-go test [ Time Frame: Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session) ]Record the time needed to perform timed up-and-go test wearing exoskeleton robot
- 6-minutes walking test [ Time Frame: Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548649
|Taipei Venterans General Hospital|
|Study Chair:||Yun-An Tsai, MD||0938-592-575|