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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

Tracking Information
First Submitted Date  ICMJE December 2, 2018
First Posted Date  ICMJE December 6, 2018
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE December 17, 2018
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03767205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients
Official Title  ICMJE The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Stroke
  • Gait, Hemiplegic
Intervention  ICMJE 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.
Study Arms  ICMJE 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)
Intervention: Device: Ankle Assist Robot
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2018)
45
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03767205
Other Study ID Numbers  ICMJE 2018-06-128
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: YunHee Kim, Kim Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP