NCT04055610

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 8, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

June 19, 2019

Last Update Submit

August 8, 2019

Conditions

Spinal Cord InjuriesParaplegia

Keywords

H-MEX powered exoskeletonExoskeleton

Outcome Measures

Primary Outcomes (2)

  • Dropout rate

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

    0-14 weeks

  • Number of adverse events

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

    0-14 weeks

Secondary Outcomes (10)

  • 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 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 body composition

    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)

  • +5 more secondary outcomes

Study Arms (1)

H-MEX

EXPERIMENTAL

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

Device: Gait training using H-MEX exoskeleton

Interventions

Gait training using H-MEX exoskeletonDEVICE

Participants will train 3 times a week for 10 weeks using H-MEX powered exoskeleton.

H-MEX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University Hospital

Seoul, 04763, South Korea

RECRUITING

Related Publications (1)

  • Kim HS, Park JH, Lee HS, Lee JY, Jung JW, Park SB, Hyun DJ, Park S, Yoon J, Lim H, Choi YY, Kim MJ. Effects of Wearable Powered Exoskeletal Training on Functional Mobility, Physiological Health and Quality of Life in Non-ambulatory Spinal Cord Injury Patients. J Korean Med Sci. 2021 Mar 29;36(12):e80. doi: 10.3346/jkms.2021.36.e80.

    PMID: 33783145DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesParaplegia

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mi Jung Kim, MD PhD

    Department of Rehabilitation medicine, Hanyang University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mi Jung Kim, MD PhD

CONTACT

82-10-2067-9353kimmjreh@hanyang.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Dept. of Rehabilitation Medicine

Study Record Dates

First Submitted

June 19, 2019

First Posted

August 14, 2019

Study Start

August 8, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)