Effects of Gait Training for Individuals With Paraplegia Using H-MEX Exoskeleton: A Pilot Study

Hanyang University Seoul Hospital1 site in 1 country10 target enrollmentAugust 8, 2019

ConditionsSpinal Cord Injuries Paraplegia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinal Cord Injuries
Sponsor: Hanyang University Seoul Hospital
Enrollment: 10
Locations: 1
Primary Endpoint: Number of adverse events
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study evaluates the feasibility and effects of H-MEX powered exoskeleton in individuals with paraplegia as a result of spinal cord injury.

Detailed Description

Participants with paraplegia will attend gait training using H-MEX powered exoskeleton 3 times a week for 10 weeks. The aim of this study is to assess the impact of gait training using H-MEX powered exoskeleton on walking ability, gait analysis, medical examination, body composition, functional evaluation, laboratory findings, quality of life, and subjective experience in individuals with paraplegia. Participants will be evaluated before, during, and after training.

Registry

clinicaltrials.gov

Start Date

August 8, 2019

End Date

December 31, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hanyang University Seoul Hospital

Responsible Party

Principal Investigator

Mi Jung Kim

Professor of Dept. of Rehabilitation Medicine

Hanyang University Seoul Hospital

Eligibility Criteria

Inclusion Criteria

•Neurologically stable paraplegia due to traumatic or non-traumatic spinal cord injury at least 2 months since injury
•Age more than 18 years
•Body weight less than 110kg, height between 160-180cm
•Sufficient postural stability to perform level transfer
•Sufficient upper extremity strength to use a walker or crutch

Exclusion Criteria

•Spinal instability
•Severe joint contracture in lower extremity
•Unhealed fracture in the major weight bearing bone in the lower extremity
•Skin compromise in areas of contact with the device
•Unresolved deep vein thrombosis
•Uncontrolled hypertension or hypotension
•Severe osteoporosis or osteoporotic fracture unable to gait training
•Lower extremity spasticity exceeding 3 out of 4 (Modified Ashworth Scale) in any joint
•Upper extremity functional limitation due to weakness or contracture
•Psychological or cognitive problem that may limit the participants to understand instructions by investigator

Outcomes

Primary Outcomes

Number of adverse events

Time Frame: 0-14 weeks

Types and number of the adverse events both serious and non-serious events during training sessions.

Dropout rate

Time Frame: 0-14 weeks

Percentage of participants who drop out before the end of the training period.

Secondary Outcomes

Changes in body composition(Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training))
Changes in bone mineral density(Initial evaluation and Final evaluation (after 10 weeks of training))
Changes in Berg balance test with H-mex exoskeleton(Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training))
Changes in oxygen uptake during gait training with H-mex exoskeleton(Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training))
Changes in heart rate during gait training with H-mex exoskeleton(Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training))
Changes in colonic transit time(Initial evaluation and Final evaluation (after 10 weeks of training))
Changes in fear for fall(Initial evaluation and Final evaluation (after 10 weeks of training))
Changes in 6 minute walking test with H-mex exoskeleton(Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training))
Changes in timed up and go test with H-mex exoskeleton(Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training))
Changes in quality of life: Short-Form 36-Item Health Survey version 2(Initial evaluation and Final evaluation (after 10 weeks of training))