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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
Sponsor:
Collaborator:
The Industrial Technology Research Institute
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief 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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Complete Spinal Cord Injury Incomplete Spinal Cord Injury Device: exoskeleton robot training Not Applicable

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.


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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. In a stable condition, for example, at least 3 months after first injury/onset, or with stable spine, or had been corrected (internal fixation).
  3. Age between 18-70.
  4. 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.
  5. Normal joint range of motion(ROM) of both lower extremities and upper extremities or ROM limitation will not affect ambulation.
  6. Can maintain trunk stability with or without hand support in sitting position for 60s.

Exclusion Criteria:

  1. Combine other neurological diseases, for example, stroke, cerebral palsy, Parkinson's disease,... etc.
  2. Femoral T-score <-2.5. (Doctor's approval must be obtained for those who with femoral t-score between -2.5 and -3).
  3. Other medical conditions which will affect weight bearing or ambulation.
  4. Medical history including fracture(due to osteoporosis in the past 2 years), heart failure, myocardial infarction.
  5. Skin conditions including allergy, pressure sore, infection, ...etc.
  6. Impaired mental or cognitive conditions that will affect training or evaluation.
  7. Severe contracture or limited joint range of motion of lower extremities.
  8. Severe spasticity which will impede the movement of exoskeleton robot.
  9. Heterotopic ossification.
  10. non-union fracture or open wound.
  11. pregnancy.
  12. other conditions that is not applicable for use the exoskeleton robot.

Information from the National Library of Medicine

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


Locations
Taiwan
Taipei Venterans General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
The Industrial Technology Research Institute
Investigators
Study Chair: Yun-An Tsai, MD 0938-592-575

Additional Information:
Publications:
Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03548649     History of Changes
Other Study ID Numbers: 2017-03-012C
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taipei Veterans General Hospital, Taiwan:
spinal cord injury
complete spinal cord injury
incomplete spinal cord injury
exoskeleton robot
gait training
security testing
functional testing

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System