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

Primary Purpose

Spinal Cord Injuries, Complete Spinal Cord Injury, Incomplete Spinal Cord Injury

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

exoskeleton robot training

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, complete spinal cord injury, incomplete spinal cord injury, exoskeleton robot, gait training, security testing, functional testing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Taipei Venterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

exoskeleton robot training group

Arm Description

subjects will receive exoskeleton robot training for 20 sessions (1 hr/session).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

timed up-and-go test

Record the time needed to perform timed up-and-go test wearing exoskeleton robot

6-minutes walking test

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.

Full Information

NCT ID

NCT03548649

First Posted

August 5, 2017

Last Updated

June 6, 2018

Sponsor

Taipei Veterans General Hospital, Taiwan

Collaborators

The Industrial Technology Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT03548649

Brief Title

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

Official Title

Clinical Research for Exoskeleton Robot

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 30, 2017 (Actual)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taipei Veterans General Hospital, Taiwan

Collaborators

The Industrial Technology Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries, Complete Spinal Cord Injury, Incomplete Spinal Cord Injury

Keywords

spinal cord injury, complete spinal cord injury, incomplete spinal cord injury, exoskeleton robot, gait training, security testing, functional testing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

AIS A-D SCI patients with injury level C7-L5

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

exoskeleton robot training group

Arm Type

Experimental

Arm Description

subjects will receive exoskeleton robot training for 20 sessions (1 hr/session).

Intervention Type

Device

Intervention Name(s)

exoskeleton robot training

Other Intervention Name(s)

gait training

Intervention Description

subjects will learn to independently use the exoskeleton robot to perform functional activities (including stand-up, sit-down, stepping forward, and walking).

Primary Outcome Measure Information:

Title

10 meters walking test

Description

Subjects walk with exoskeleton for 10 metres, with the time measured for the intermediate 6 metres to allow for acceleration and deceleration.

Time Frame

Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session)

Secondary Outcome Measure Information:

Title

timed up-and-go test

Description

Record the time needed to perform timed up-and-go test wearing exoskeleton robot

Time Frame

Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session)

Title

6-minutes walking test

Description

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.

Time Frame

Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. In a stable condition, for example, at least 3 months after first injury/onset, or with stable spine, or had been corrected (internal fixation). Age between 18-70. 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. Normal joint range of motion(ROM) of both lower extremities and upper extremities or ROM limitation will not affect ambulation. Can maintain trunk stability with or without hand support in sitting position for 60s. Exclusion Criteria: Combine other neurological diseases, for example, stroke, cerebral palsy, Parkinson's disease,... etc. Femoral T-score <-2.5. (Doctor's approval must be obtained for those who with femoral t-score between -2.5 and -3). Other medical conditions which will affect weight bearing or ambulation. Medical history including fracture(due to osteoporosis in the past 2 years), heart failure, myocardial infarction. Skin conditions including allergy, pressure sore, infection, ...etc. Impaired mental or cognitive conditions that will affect training or evaluation. Severe contracture or limited joint range of motion of lower extremities. Severe spasticity which will impede the movement of exoskeleton robot. Heterotopic ossification. non-union fracture or open wound. pregnancy. other conditions that is not applicable for use the exoskeleton robot.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yun-An Tsai, MD

Organizational Affiliation

0938-592-575

Official's Role

Study Chair

Facility Information:

Facility Name

Taipei Venterans General Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

1991946

Citation

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.

Results Reference

background

PubMed Identifier

15706542

Citation

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.

Results Reference

background

PubMed Identifier

10414771

Citation

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.

Results Reference

background

Links:

URL

http://www.who.int/mediacentre/factsheets/fs384/en/

Description

World Health Organization

URL

http://www.fsci.org.tw/ap/news_view.aspx?bid=21&sn=6907d6d9-18ec-4901-bca4-aa56065444a9

Description

foundation of spinal cord injury, R.O.C

Learn more about this trial

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

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