Gait Training for Individuals With Paraplegia Using the H-MEX Exoskeleton

Hanyang University Seoul Hospital

Status: Unknown

Conditions: Spinal Cord Injuries; Paraplegia

Treatments: Device: Gait training using H-MEX exoskeleton

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04055610

Hanyang University Hospital

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Any other issue that may interfere with the trial

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

H-MEX

Experimental group

Description:

10 participants with paraplegia will participate in explorative gait training using H-MEX powered exoskeleton.

Treatment:

Device: Gait training using H-MEX exoskeleton