StrokeNCT03767205
The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients
A study testing Ankle Assist Robot in people with Stroke and Gait, Hemiplegic, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The aim of this study was to identify the assistance effect of Ankle Assist Robot v1 developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) by comparing 1. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke, Gait, Hemiplegic
- What is being tested?
- Ankle Assist Robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Dec 2018to 1 Dec 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke patients with hemiplegia over 19 years old
- Ischemic or hemorrhagic stroke patients over 3 months of onset
- Functional Ambulation Category Scale with 3 or more scales
Who cannot join
- Stroke patients who have difficulty in walking independently regardless of assistive devices due to problems such as visual field defects or fractures
- Stroke patients with walking difficulty due to serious cognitive problems
- Patients with a foot size of 230 mm or less or a stroke of 280 mm or more that are not suitable for wearing ankle assist robot
- Stroke patients at risk of falling when walking with severe dizziness
- Modified ashworth scale (MAS) Stroke patients over 3
- Pregnant woman
- People with mental illness and psychiatric medication
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to identify the assistance effect of Ankle Assist Robot v1 developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) by comparing
- gait function during overground gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)
- the energy expenditure during treadmill gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)
- Conditions
- Stroke, Gait, Hemiplegic
- Being tested
- Ankle Assist Robot
- Keywords
- gait function, Metabolic energy expenditure, ankle assist robot
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Assist RobotDevice
- overground walking in three conditions (with robot-torque on/with robot-torque off/without robot). During overground walking, gait function was measured using motion analysis, sEMG, and force plate
- treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot). During treadmill walking, the metabolic energy expenditure was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).
| Study group | Role | What they receive |
|---|---|---|
| stroke patients | Experimental | All participants perform overground walking and treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot). Receives: Device: Ankle Assist Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on gait speed in different three conditions
All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of gait speed using a motion analysis.
Measured: 20minutes
Secondary outcomes (4)
Change on gait function in different three conditions (kinematic)
All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of kinematic using a motion analysis.
Measured: 20minutes
Change on gait function in different three conditions (kinetic)
All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of kinetic using a force plate.
Measured: 20minutes
Change on gait function in different three conditions (muscle activation)
All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of muscle activation using a surface EMG.
Measured: 20minutes
Change on metabolic energy expenditure in different three conditions
All participants perform treadmill walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of metabolic energy expenditure using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start17 Dec 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
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 StrokeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YunHee Kim, Kim, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767205
- Sponsor's protocol ID
- 2018-06-128
- Status last verified
- Dec 2018
- First submitted
- 2 Dec 2018
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee SH, Kim J, Lee HJ, Kim YH. A wearable ankle-assisted robot for improving gait function and pattern in stroke patients. J Neuroeng Rehabil. 2025 Apr 22;22(1):89. doi: 10.1186/s12984-025-01624-w.
PubMed 40264191
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients
- ClinicalTrials.gov ID
- NCT03767205
- Acronym / sponsor ID
- 2018-06-128
- Conditions
- Stroke, Gait, Hemiplegic
- Keywords
- gait function, Metabolic energy expenditure, ankle assist robot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 6 Dec 2018 (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.
The aim of this study was to identify the assistance effect of Ankle Assist Robot v1 developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) by comparing
- gait function during overground gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)
- the energy expenditure during treadmill gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke patients | Experimental | Device: Ankle Assist RobotAll participants perform overground walking and treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stroke patients with hemiplegia over 19 years old
- Ischemic or hemorrhagic stroke patients over 3 months of onset
- Functional Ambulation Category Scale with 3 or more scales
Key exclusion criteria (7 listed)
- Stroke patients who have difficulty in walking independently regardless of assistive devices due to problems such as visual field defects or fractures
- Stroke patients with walking difficulty due to serious cognitive problems
- Patients with a foot size of 230 mm or less or a stroke of 280 mm or more that are not suitable for wearing ankle assist robot
- Stroke patients at risk of falling when walking with severe dizziness
- Modified ashworth scale (MAS) Stroke patients over 3
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 |
|---|---|---|
| Ankle Assist Robot1. overground walking in three conditions (with robot-torque on/with robot-torque off/without robot). During overground walking, gait function was measured using motion analysis, sEMG, and force plate 2. treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot). During treadmill walking, the metabolic energy expenditure was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy). | Device | stroke patients |
Primary outcome
Change on gait speed in different three conditions
Time frame: 20minutes
All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of gait speed using a motion analysis.
4 secondary outcomes
Change on gait function in different three conditions (kinematic)
Time frame: 20minutes
Change on gait function in different three conditions (kinetic)
Time frame: 20minutes
Change on gait function in different three conditions (muscle activation)
Time frame: 20minutes
Change on metabolic energy expenditure in different three conditions
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Derived from this study: PubMed 40264191Lee SH, Kim J, Lee HJ, Kim YH. A wearable ankle-assisted robot for improving gait function and pattern in stroke patients. J Neuroeng Rehabil. 2025 Apr 22;22(1):89. doi: 10.1186/s12984-025-01624-w.
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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.
YunHee Kim, Kim principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle Assist Robot in people with Stroke and Gait, Hemiplegic, run by Samsung Medical Center 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 9 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on gait speed in different three conditions (time frame: 20minutes). 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 NCT03767205, 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 9 Dec 2019.