Spinal Cord InjuriesNCT04055610
Gait Training for Individuals With Paraplegia Using the H-MEX Exoskeleton
A study testing Gait training using H-MEX exoskeleton in people with Spinal Cord Injuries and Paraplegia, run by Hanyang University Seoul Hospital at 1 site in South Korea.
Trial summary
This study evaluates the feasibility and effects of H-MEX powered exoskeleton in individuals with paraplegia as a result of spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Paraplegia
- What is being tested?
- Gait training using H-MEX exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Aug 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University Hospital
Seoul, 04763
Mi Jung Kim, MD PhD, 82-10-2067-9353, kimmjreh@hanyang.ac.kr
About this study
Official title: Effects of Gait Training for Individuals With Paraplegia Using H-MEX Exoskeleton: A Pilot Study
This study evaluates the feasibility and effects of H-MEX powered exoskeleton in individuals with paraplegia as a result of spinal cord injury.
Read the 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.
- Conditions
- Spinal Cord Injuries, Paraplegia
- Being tested
- Gait training using H-MEX exoskeleton
- Keywords
- H-MEX powered exoskeleton, Exoskeleton
- Medical subject headings
- Spinal Cord Injuries, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait training using H-MEX exoskeletonDevice
Participants will train 3 times a week for 10 weeks using H-MEX powered exoskeleton.
| Study group | Role | What they receive |
|---|---|---|
| H-MEX | Experimental | 10 participants with paraplegia will participate in explorative gait training using H-MEX powered exoskeleton. Receives: Device: Gait training using H-MEX exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dropout rate
Percentage of participants who drop out before the end of the training period.
Measured: 0-14 weeks
Number of adverse events
Types and number of the adverse events both serious and non-serious events during training sessions.
Measured: 0-14 weeks
Secondary outcomes (10)
Changes in 6 minute walking test with H-mex exoskeleton
Distance walked over a span of 6 minutes will be examined.
Measured: 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
Time that a participants takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured.
Measured: 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
Balance will be evaluated by using Berg balance test which is 14-item test designed to assess balance (score range: 0-56, higher values represent a better outcome).
Measured: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Changes in body composition
Body composition will be assessed by using bioelectric impedence analysis.
Measured: 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
Average and peak oxygen uptake will be measured with participants during gait training.
Measured: 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
Average and peak heart rate will be measured with participants during gait training.
Measured: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Changes in bone mineral density
Bone mineral density will be measured at hip and spine by dual energy X-ray absorptiometry.
Measured: Initial evaluation and Final evaluation (after 10 weeks of training)
Changes in colonic transit time
Colonic mobility will be assessed by colonic transit time.
Measured: Initial evaluation and Final evaluation (after 10 weeks of training)
Changes in quality of life: Short-Form 36-Item Health Survey version 2
Quality of life will be assessed by Short-Form 36-Item Health Survey version 2 (total score range: 0-100, higher values represent a better outcome).
Measured: Initial evaluation and Final evaluation (after 10 weeks of training)
Changes in fear for fall
Fear for fall will be assessed by fall efficacy scale which is 16-item test (score range: 16-64, higher values represent a worse outcome).
Measured: Initial evaluation and Final evaluation (after 10 weeks of training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start8 Aug 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hyundai Motor Company
- Responsible party
- Principal investigator, Mi Jung Kim, Hanyang University Seoul Hospital
- Investigators
- Mi Jung Kim, MD PhD, Principal investigator, Department of Rehabilitation medicine, Hanyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055610
- Sponsor's protocol ID
- Hanyang University Hospital
- Status last verified
- Aug 2019
- First submitted
- 19 Jun 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33783145
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gait Training for Individuals With Paraplegia Using H-MEX Exoskeleton: A Pilot Study
- ClinicalTrials.gov ID
- NCT04055610
- Acronym / sponsor ID
- Hanyang University Hospital
- Conditions
- Spinal Cord Injuries, Paraplegia
- Keywords
- H-MEX powered exoskeleton, Exoskeleton
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Collaborators
- Hyundai Motor Company
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H-MEX | Experimental | Device: Gait training using H-MEX exoskeleton10 participants with paraplegia will participate in explorative gait training using H-MEX powered exoskeleton. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait training using H-MEX exoskeletonParticipants will train 3 times a week for 10 weeks using H-MEX powered exoskeleton. | Device | H-MEX |
Primary outcome
Dropout rate
Time frame: 0-14 weeks
Percentage of participants who drop out before the end of the training period.
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.
10 secondary outcomes
Changes in 6 minute walking test with H-mex exoskeleton
Time frame: 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
Time frame: 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
Time frame: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Changes in body composition
Time frame: 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
Time frame: 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
Time frame: Initial evaluation, mid-evaluation (after 5 weeks of training), and Final evaluation (after 10 weeks of training)
Changes in bone mineral density
Time frame: Initial evaluation and Final evaluation (after 10 weeks of training)
Changes in colonic transit time
Time frame: Initial evaluation and Final evaluation (after 10 weeks of training)
Changes in quality of life: Short-Form 36-Item Health Survey version 2
Time frame: Initial evaluation and Final evaluation (after 10 weeks of training)
Changes in fear for fall
Time frame: Initial evaluation and Final evaluation (after 10 weeks of training)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Derived from this study: PubMed 33783145Kim 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.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mi Jung Kim, MD PhD principal investigator
Department of Rehabilitation medicine, Hanyang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait training using H-MEX exoskeleton in people with Spinal Cord Injuries and Paraplegia, run by Hanyang University Seoul Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mi Jung Kim, MD PhD (82-10-2067-9353, kimmjreh@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dropout rate (time frame: 0-14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04055610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.