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

Evaluation of the Physiological and Psychological Effects of Ambulation Training Utilizing an Exoskeleton Robot on Subjects With Spinal Cord Injury

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Ambulation training utilizing an exoskeleton robot

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung City, Taiwan, 404
    • Recruiting
    • China Medical University Hospial
    • Principal Investigator: Nai-Hsin Meng, M.D.
    • Contact: Nai-Hsin Meng, M.D.; Phone Number: 2381 886-4-22052121; Email: nsmeng@ms13.hinet.net
    • Sub-Investigator: Li-Wei Chou, M.D. Ph.D.
    • Sub-Investigator: Pei-Yu Yang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• 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 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36	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.	change from baseline at 1 week after completion of 40 hours of ambulation training
Spinal Cord Injury-Quality of Life measurement system	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.	change from baseline at 1 week after completion of 40 hours of ambulation training
fat mass	fat mass measured by dual X-ray absorptiometry	change from baseline at 1 week after completion of ambulation training
lean body mass	lean body mass measured by dual X-ray absorptiometry	change from baseline at 1 week after completion of 40 hours of ambulation training
Berg Balance Scale	measuring sitting balance ability; minimum score: 0, maximu score 56; higher values represent a better outcome	change from baseline at 1 week after completion of 40 hours of ambulation training

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Nai-Hsin Meng, M.D., China Medical University, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2017
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 5, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Rehabilitation; Quality of Life; Body composition; Exoskeleton Device
• 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: DMR-107-085

Drug and device information, study documents

• 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