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CompletedNCT03767205Updated Dec 9, 2019

The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients

An interventional study of Ankle Assist Robot in Stroke and Gait, Hemiplegic, sponsored by Samsung Medical Center. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-12-09.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study 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. gait function during overground gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)
  2. the energy expenditure during treadmill gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)
02

Conditions studied

  • Stroke
  • Gait, Hemiplegic

Keywords

  • gait function
  • Metabolic energy expenditure
  • ankle assist robot
03

In context

Stroke

7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 45 is close to the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Browse Samsung Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    stroke patients

    All participants perform overground walking and treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot).

    Device: Ankle Assist Robot

Interventions

  • DeviceAnkle Assist Robot

    1. 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 20minutes

Secondary outcomes

  1. 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.

    Time frame: 20minutes

  2. 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.

    Time frame: 20minutes

  3. 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.

    Time frame: 20minutes

  4. 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).

    Time frame: 1 hour

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, South Korea
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2018 to primary completion in Dec 2019, 11 months.

Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 11 months is below that.

Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2018
First posted
Dec 6, 2018
StartActual
Dec 17, 2018
Primary completionActual
Dec 1, 2019
CompletionActual
Dec 1, 2019
Last update
Dec 9, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03767205
Lead sponsor
Samsung Medical Center
Responsible party
Sponsor
First posted
Dec 6, 2018
Start date
Dec 17, 2018
Primary completion
Dec 1, 2019
Completion
Dec 1, 2019
Last update
Dec 9, 2019

Study contacts

YunHee Kim, Kim
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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