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

NCT ID: NCT03767205

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-17

Study Completion Date

2019-12-01

Brief Summary

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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)

Detailed Description

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Conditions

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Stroke Gait, Hemiplegic

Keywords

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gait function Metabolic energy expenditure ankle assist robot

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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stroke patients

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

Group Type EXPERIMENTAL

Ankle Assist Robot

Intervention Type DEVICE

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).

Interventions

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Ankle 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).

Intervention Type DEVICE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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YunHee Kim, Kim

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 40264191 (View on PubMed)

Other Identifiers

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2018-06-128

Identifier Type: -

Identifier Source: org_study_id