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

NCT ID: NCT03548649

Last Updated: 2018-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-30
• Study Completion Date: 2018-12-31

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.

Conditions

Spinal Cord Injuries; Complete Spinal Cord Injury; Incomplete Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

exoskeleton robot training group

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

Group Type: EXPERIMENTAL

exoskeleton robot training

Intervention Type: DEVICE

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

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

gait training

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Industrial Technology Research Institute

OTHER

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yun-An Tsai, MD

Role: STUDY_CHAIR

0938-592-575

Locations

Taipei Venterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 1991946 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15706542 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10414771 (View on PubMed)

Related Links

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

World Health Organization

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

foundation of spinal cord injury, R.O.C

Other Identifiers

2017-03-012C

Identifier Type: -

Identifier Source: org_study_id