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

NCT03548649 | Unknown

• 1 other identifier: 2017-03-012C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• timed up-and-go test

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

• 6-minutes walking test

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

Study Arms (1)

exoskeleton robot training group

EXPERIMENTAL

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

Device: exoskeleton robot training

Interventions

exoskeleton robot training DEVICE

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

Also known as: gait training

exoskeleton robot training group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• The Industrial Technology Research Institute: collaborator

Study Sites (1)

Taipei Venterans General Hospital

Taipei, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 1991946 BACKGROUND

• 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.

  PMID: 15706542 BACKGROUND

• 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.

  PMID: 10414771 BACKGROUND

Related Links

• World Health Organization
• foundation of spinal cord injury, R.O.C

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Yun-An Tsai, MD

  0938-592-575

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: AIS A-D SCI patients with injury level C7-L5

Study Record Dates

• First Submitted: August 5, 2017
• First Posted: June 7, 2018
• Study Start: August 30, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: June 7, 2018

Record last verified: 2018-06

Locations

TW (1)