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

Clinical Research for Exoskeleton Robot

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injuries; Complete Spinal Cord Injury; Incomplete Spinal Cord Injury
• Intervention / Treatment: Device: exoskeleton robot training

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
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Venterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: gait training

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
timed up-and-go test	Record the time needed to perform timed up-and-go test wearing exoskeleton robot	Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session)
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.	Test will be held before starting the first training session and after completing 20 training sessions.(1 hour per session)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• World Health Organization
• foundation of spinal cord injury, R.O.C
• Development Center of Spinal Cord Injury

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: August 5, 2017
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 7, 2018

Study Record Updates

• Last Update Posted (Actual): June 7, 2018
• Last Update Submitted That Met QC Criteria: June 6, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: spinal cord injury; incomplete spinal cord injury; complete spinal cord injury; exoskeleton robot; gait training; security testing; functional testing
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 2017-03-012C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No