NCT03767205

Brief 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. 1.gait function during overground gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)
  2. 2.the energy expenditure during treadmill gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

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

December 2, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

December 17, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2018

Enrollment Period

12 months

First QC Date

December 2, 2018

Last Update Submit

December 5, 2019

Conditions

StrokeGait, Hemiplegic

Keywords

gait functionMetabolic energy expenditureankle assist robot

Outcome Measures

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.

    20minutes

Secondary Outcomes (4)

  • Change on gait function in different three conditions (kinematic)

    20minutes

  • Change on gait function in different three conditions (kinetic)

    20minutes

  • Change on gait function in different three conditions (muscle activation)

    20minutes

  • Change on metabolic energy expenditure in different three conditions

    1 hour

Study Arms (1)

stroke patients

EXPERIMENTAL

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

Ankle Assist RobotDEVICE

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).

stroke patients

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 40264191DERIVED

MeSH Terms

Conditions

StrokeGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • YunHee Kim, Kim

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2018

First Posted

December 6, 2018

Study Start

December 17, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 9, 2019

Record last verified: 2018-12

Locations

KR(1)