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Effects of Ambulation Training Utilizing an Exoskeleton Robot on Subjects With Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03340792
Recruitment Status : Unknown
Verified January 2018 by Nai-Hsin Meng, China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : November 14, 2017
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Nai-Hsin Meng, China Medical University Hospital

Study Description
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Brief Summary:
The present study aims to investigate the effects of ReWalk exoskeleton robot training on various physiological and psychological parameters among subjects with spinal cord injury, including body composition and bone mineral mass, balance ability, bowel and bladder symptoms, severity of pain, psychological well-being, and quality of life. Ten patients with paraplegia caused by spinal cord injury will be recruited from the out-patient clinic of Department of Physical Medicine and Rehabilitation at the China Medical University hospital. All participants will undergo dual X-ray absorptiometry to evaluate the baseline bone mineral density. Eligible participants will then take ReWalk training sessions comprises of 3 x 1-hour sessions per week for 40 sessions. A comprehensive battery of outcome measures, including body composition and bone mineral mass, balance ability, bowel and bladder symptoms, severity of pain, psychological well-being, and quality of life, will be utilized for comparison after 40 sessions of ReWalk ambulation training.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Ambulation training utilizing an exoskeleton robot Not Applicable

Detailed Description:

The loss of upright mobility has a profound effect on the health and quality of life for individuals with a spinal cord injury (SCI). The ReWalk exoskeleton is an FDA-cleared, wearable, computer-controlled exoskeleton robot that enables subjects with SCI to stand and walk using crutches to keep balance. China Medical University Hospital is the second hospital in Taiwan to acquire this relatively new rehabilitation robot. ReWalk exoskeleton not only helps the patients with paraplegia regain their ability to walk, previous studies also suggest that restoration of upright mobility may help mitigate the physical and psychological decline routinely experienced by individuals with SCI.

The present study aims to investigate the effects of ReWalk exoskeleton robot training on various physiological and psychological parameters among subjects with spinal cord injury, including body composition and bone mineral mass, balance ability, bowel and bladder symptoms, severity of pain, psychological well-being, and quality of life. Ten patients with paraplegia caused by spinal cord injury will be recruited from the out-patient clinic of Department of Physical Medicine and Rehabilitation at the China Medical University hospital. All participants will undergo dual X-ray absorptiometry to evaluate the baseline bone mineral density. Eligible participants will then take ReWalk training sessions comprises of 3 x 1-hour sessions per week for 40 sessions. The first 20 or so hours of training sessions focus on basic ReWalk skills, and the following training sessions focus on advanced ReWalk skills. A comprehensive battery of outcome measures, including body composition and bone mineral mass, balance ability, bowel and bladder symptoms, severity of pain, psychological well-being, and quality of life, will be utilized to obtain an in-depth overview and comparison of the treatment efficacy after 40 sessions of ReWalk ambulation training. The measures include: muscle strength measurements, Berg Balance Scale, modified Functional Reach Test, 10-Meters Walking Test, Timed Up and Go test, the Short Form-36 and Spinal Cord Injury-Quality Of Life questionnaires for health-related quality of life measurement. Dual X-ray absorptiometry will be used to measure the bone mineral density of the lumbar spine, the proximal femoral region and the distal forearms. It will also be used to estimate fat mass and lean body mass of the participants. All the outcome assessments, except for the Timed Up and Go and the 10-Metersr Walking Test, will be performed prior to the first training session and again at the end of the ReWalk ambulation training sessions. Descriptive data will be provided for all demographic parameters and with a mix-design ANOVA analysis employed to compare pre- and post-training conditions for all repeated outcome measures.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Physiological and Psychological Effects of Ambulation Training Utilizing an Exoskeleton Robot on Subjects With Spinal Cord Injury
Actual Study Start Date : November 23, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exoskeleton robot ambulation training
Ambulation training utilizing an exoskeleton robot
 Device: Ambulation training utilizing an exoskeleton robot
Participants undergo 40 hours of ambulation training utilizing an exosksleton robot within 3 months.


Outcome Measures
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Primary Outcome Measures :
  1. bone mineral density [ Time Frame: Change from baseline at 1 week after completion of 40 hours of ambulation training ]
    bone mineral density of the lumbar spine, the proximal femoral region and the distal forearms, measured by dual X-ray absorptiometry


Secondary Outcome Measures :
  1. SF-36 [ Time Frame: change from baseline at 1 week after completion of 40 hours of ambulation training ]
    SF-36 contains 36 items comprising eight subscales: physical functioning (PF), role limitations due to physical problems (RP), bodily pain, general health perceptions (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). All subscales are transformed into a 0-100 scale, with 100 indicating the best status.

  2. Spinal Cord Injury-Quality of Life measurement system [ Time Frame: change from baseline at 1 week after completion of 40 hours of ambulation training ]

    The SCI-QOL consists of 19 item banks, including the SCI-Functional Index banks, and 3 fixed-length scales measuring physical, emotional, and social aspects of health-related QOL (HRQOL). A description of the score range (and which values are considered to be a better or worse outcome) is not included because it greatly exceeds the 999-character limitation allowed in the box of "descrpition"

    Emotional Health Domain:

    Positive Affect & Well-Being, Depression, Anxiety, Stigma, Resilience, Grief/Loss, Self-Esteem and Psychological Trauma

    Physical-Medical Health Domain:

    Skin/Pressure Ulcers Scale, Bladder Complications Scale, Bladder Management Difficulties, Bowel Management Difficulties, Pain Interference and Pain Behavior Scale.

    Social Participation Domain:

    Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles and Activities, Independence.

    SCI-Functional Index banks: Basic Mobility, Ambulation, Fine Motor, Self-Care and Wheelchair activities.


  3. fat mass [ Time Frame: change from baseline at 1 week after completion of ambulation training ]
    fat mass measured by dual X-ray absorptiometry

  4. lean body mass [ Time Frame: change from baseline at 1 week after completion of 40 hours of ambulation training ]
    lean body mass measured by dual X-ray absorptiometry

  5. Berg Balance Scale [ Time Frame: change from baseline at 1 week after completion of 40 hours of ambulation training ]
    measuring sitting balance ability; minimum score: 0, maximu score 56; higher values represent a better outcome


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between the age of 20-65 years old;
  2. Have paraplegia resulting from thoracic or lumbar spinal cord injury.
  3. At least 6 months after onset of the spinal cord injury
  4. Well motivated and willing to participate 40 hours of ReWalk ambulation training sessions.

Exclusion Criteria:

  1. Have spinal cord injury neurologic level above T4
  2. Height greater than 190 cm or lower than160 cm
  3. Weight greater than 100 kg
  4. Have osteoporosis (T-score < -2.5)
  5. Deep vein thrombosis
  6. Severe orthostatic hypotension precluding standing and walking training
  7. Pregnancy
  8. Cognitive impairments that would impact on the safe participation in the study
  9. Severe spasticity of lower limbs (Modified Ashworth Scale >3)
  10. Contracture of the ankle, or a knee flexion contracture greater than 10 degrees
  11. Musculoskeletal conditions that affected gait capacity
  12. Co-existence of other neurological diseases
Contacts and Locations
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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): NCT03340792


Contacts
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Contact: Nai-Hsin Meng, M.D. 886-4-22052121 ext 2381 nsmeng@ms13.hinet.net

Locations
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Taiwan
China Medical University Hospial Recruiting
Taichung City, Taiwan, 404
Contact: Nai-Hsin Meng, M.D.    886-4-22052121 ext 2381    nsmeng@ms13.hinet.net   
Principal Investigator: Nai-Hsin Meng, M.D.         
Sub-Investigator: Li-Wei Chou, M.D. Ph.D.         
Sub-Investigator: Pei-Yu Yang, M.D.         
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: Nai-Hsin Meng, M.D. China Medical University, China Medical University Hospital
More Information
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Responsible Party: Nai-Hsin Meng, Director, Department of Physical Medicine and Rehabilitation, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03340792    
Other Study ID Numbers: DMR-107-085
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Nai-Hsin Meng, China Medical University Hospital:
Exoskeleton Device
Rehabilitation
Body composition
Quality of Life
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System