NCT03548649

The Efficacy and Safety of a New Power Exoskeleton Robot for Improving Walking Ability in Spinal Cord Injury Patients

Clinical Research for Exoskeleton Robot

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Spinal Cord Injuries
• Complete Spinal Cord Injury
• Incomplete Spinal Cord Injury

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-08-30
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-06-07
• Last updated: 2018-06-07

Locations

1 site across 1 country: Taiwan