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

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ClinicalTrials.gov Identifier: NCT03767205
Recruitment Status : Completed
First Posted : December 6, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

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)
  3. the result of Timed up and go test in two conditions (with robot-assist torque on/without robot)

Condition or disease Intervention/treatment Phase
Stroke Gait, Hemiplegic Device: Ankle Assist Robot Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients
Actual Study Start Date : December 17, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : February 28, 2019

Arm Intervention/treatment
Experimental: stroke patients
All participants perform overground walking and treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot), and timed up and go test in two conditions (with robot-torque on/without robot)
Device: 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, 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).
  3. Timed up and go test.




Primary Outcome Measures :
  1. Change on metabolic energy expenditure in different three conditions [ Time Frame: 1 hour ]
    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).


Secondary Outcome Measures :
  1. The Timed Up and Go test (TUG) in different two conditions [ Time Frame: 10minutes ]
    The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.

  2. Change on gait function in different three conditions (kinematic) [ Time Frame: 20minutes ]
    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.

  3. Change on gait function in different three conditions (kinetic) [ Time Frame: 20minutes ]
    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.

  4. Change on gait function in different three conditions (muscle activation) [ Time Frame: 20minutes ]
    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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767205


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: YunHee Kim, Kim Samsung Medical Center

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03767205     History of Changes
Other Study ID Numbers: 2018-06-128
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samsung Medical Center:
gait function
Metabolic energy expenditure
ankle assist robot
Additional relevant MeSH terms:
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Stroke
Gait Disorders, Neurologic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms