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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03767205
Enrollment
45
Registered
2018-12-06
Start date
2018-12-17
Completion date
2019-12-01
Last updated
2019-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait, Hemiplegic, Stroke

Keywords

gait function, Metabolic energy expenditure, ankle assist robot

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. 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)

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).

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change on gait speed in different three conditions20minutesAll 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.

Secondary

MeasureTime frameDescription
Change on gait function in different three conditions (kinematic)20minutesAll 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.
Change on gait function in different three conditions (kinetic)20minutesAll 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.
Change on gait function in different three conditions (muscle activation)20minutesAll 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.
Change on metabolic energy expenditure in different three conditions1 hourAll 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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026