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

NCT ID: NCT03340792

Last Updated: 2018-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-23
• Study Completion Date: 2019-12-31

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.

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.

Conditions

Spinal Cord Injuries

Study Design

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

Study Groups

Exoskeleton robot ambulation training

Ambulation training utilizing an exoskeleton robot

Group Type: EXPERIMENTAL

Ambulation training utilizing an exoskeleton robot

Intervention Type: DEVICE

Participants undergo 40 hours of ambulation training utilizing an exosksleton robot within 3 months.

Interventions

Ambulation training utilizing an exoskeleton robot

Participants undergo 40 hours of ambulation training utilizing an exosksleton robot within 3 months.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nai-Hsin Meng

Director, Department of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nai-Hsin Meng, M.D.

Role: PRINCIPAL_INVESTIGATOR

China Medical University, China Medical University Hospital

Locations

China Medical University Hospial

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Nai-Hsin Meng, M.D.

Role: CONTACT

nsmeng@ms13.hinet.net

886-4-22052121 ext. 2381

Facility Contacts

Nai-Hsin Meng, M.D.

Role: primary

nsmeng@ms13.hinet.net

886-4-22052121 ext. 2381

Other Identifiers

DMR-107-085

Identifier Type: -

Identifier Source: org_study_id