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Comparisons of Two Types of Robot Assisted Gait Training

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ClinicalTrials.gov Identifier: NCT03341065
Recruitment Status : Unknown
Verified November 2017 by Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea.
Recruitment status was:  Recruiting
First Posted : November 14, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

Study Description
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Brief Summary:
Comparisons of Two Types of Robot Assisted Gait Training: Exoskeleton Type Robot vs. End-effector Type Robot: Randomized Controlled Trial

Condition or disease Intervention/treatment Phase
Stroke Robot Assisted Gait Training Device: exoskeleton type robot Device: end-effector type robot Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparisons of Two Types of Robot Assisted Gait Training: Exoskeleton Type Robot vs. End-effector Type Robot: Randomized Controlled Trial
Study Start Date : April 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: exoskeleton type robot
exoskeleton type robot assisted gait training (Lokomat orthosis)
 Device: exoskeleton type robot
Experimental: end-effector type robot
end-effector type robot assisted gait training (G-EO system)
 Device: end-effector type robot


Outcome Measures
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Primary Outcome Measures :
  1. Change of Range of motion of ankle joint at 4 weeks [ Time Frame: 4 weeks from baseline ]
    ankle joint motion of sagittal plane during gait


Secondary Outcome Measures :
  1. Trunk impairment scale [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline ]
    Trunk impairment scale performs to evaluate the sitting balance and trunk control ability examining static sitting balance, dynamic sitting balance, and coordination, and the maximum score on the subscales are 7, 10, and 6 points, repectively. The total score ranges from 0 to 23 points, a higher score indicating a better trunk performance.

  2. Berg Balance Scale [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline ]
    Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life. Each task is scored on a five-point scale (0-4) floolwing the guidelines of the test develpers, and the maximum score on this test is 56 which indicates balance ability within the normal range.

  3. 10m walk test [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline ]
    10m walk test is used to examine gait speed, in which participant was asked to walk on a 14 meter of walkway wearing harness with two conditions; with the fastest speed or with self-selected comfortable speed.

  4. Fugl-Meyer Assessment [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline ]
    Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity. It includes 17 items of a 3-point ordinal scale, ranging 0-34, with higher scores indicating lower impairment.

  5. Korean version of Falls efficacy scale [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline ]
    Korean version of Falls efficacy scale asks subjects to rank their confidence about their ability not to fall while performing a variety of activities of daily living with a maximum score of 100

  6. Range of motion of hip joint [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline ]
    Hip joint motion of sagittal plane during gait

  7. Range of motion of knee joint [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline ]
    knee joint motion of sagittal plane during gait

  8. Range of motion of ankle joint [ Time Frame: Baseline, 8 weeks from baseline ]
    ankle joint motion of sagittal plane during gait

  9. Electromyography of lower extremities [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline ]
    Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait.

  10. Plantar pressure [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline ]
    Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait

  11. Step length, time [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline ]
    Step length, stance time, swing time, and stride time during gait

  12. Functional Ambulation Category [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline ]
    Functional Ambulation Category is used to assess gait ability with 6 levels ranging from 0 to 5 on the basis of the amount of physical support required, regardless of use of an assistive device


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemiplegic patients secondary to first cerebrovascular accidents
  • Ankle dorsiflexor strength: medical research council scale 2 or 3
  • Functional ambulation category score 3

Exclusion Criteria:

  • History of surgery of affected lower limb
  • Fracture of affected lower limb
Contacts and Locations
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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): NCT03341065


Contacts
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Contact: Joon-Ho Shin, MS 82-2-901-1884 asfreelyas@gmail.com

Locations
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Korea, Republic of
National Rehabilitation Center Recruiting
Seoul, Korea, Republic of, 142884
Contact: Joon-Ho Shin, MS         
Principal Investigator: Joon-Ho Shin, MS         
Sponsors and Collaborators
National Rehabilitation Center, Seoul, Korea
Investigators
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Principal Investigator: Joon-Ho Shin, MS National Rehabilitation Center
More Information
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Additional Information:

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Responsible Party: Joon-Ho Shin, Principal Investigator, National Rehabilitation Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT03341065    
Other Study ID Numbers: NRC-2016-01-006
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No