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

Samsung Medical Center logo

Samsung Medical Center

Status

Completed

Conditions

Stroke
Gait, Hemiplegic

Treatments

Device: Ankle Assist Robot

Study type

Interventional

Funder types

Other

Identifiers

NCT03767205
2018-06-128

Details and patient eligibility

About

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)

Enrollment

45 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

stroke patients
Experimental group
Description:
All participants perform overground walking and treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot).
Treatment:
Device: Ankle Assist Robot

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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