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

NCT03340792 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-01-08

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries

Interventions

DEVICE

Ambulation training utilizing an exoskeleton robot

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

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Nai-Hsin Meng, M.D. · China Medical University, China Medical University Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-23
Primary Completion
2019-10-31
Completion
2019-12-31
FDA Device
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03340792 on ClinicalTrials.gov