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Effect of Robot-assisted Gait Training on Brain Reorganization in Hemiplegic Patients

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ClinicalTrials.gov Identifier: NCT02569190
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Dae Hyun, Veterans Health Service Medical Center, Seoul, Korea

Brief Summary:
Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in hemiplegia patients.

Condition or disease Intervention/treatment Phase
Stroke Device: Walkbot Not Applicable

Detailed Description:
This study designed an interventional pre-post compared clinical study. The subjects received conventional physical therapy with Walkbot training (3 sessions per week for 7 weeks, 20 session). Before and after intervention all subjects evaluated using diffusion tensor imaging and clinical outcome measurements.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Robot-assisted Gait Training on Brain Reorganization in Hemiplegic Patients
Study Start Date : June 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Walkbot
Receive conventional physical therapy (session I for 30 min/day) with Walkbot training 3 days a week for 8 weeks, 20 session in all.
Device: Walkbot
Robot assisted gait training




Primary Outcome Measures :
  1. Change from baseline fraction anisotropy of corticoreticular tract in Diffusion tensor imaging 8 weeks after the first day of intervention [ Time Frame: at the first day of intervention and 8 weeks after the first day ]

Secondary Outcome Measures :
  1. Functional ambulation category [ Time Frame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day ]
    The functional ambulation category was designed to examine the levels of assistance required during a 15m walk. Six categories are included in the functional ambulation category: 0 (non-ambulatory), 1 (needs continuous support from one person), 2 (needs intermittent support from one person), 3 (needs only verbal supervision), 4 (help is required on stairs and uneven surfaces), and 5 (can walk independently anywhere).

  2. Fugl-meyer assessment [ Time Frame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day ]
  3. Medical research council [ Time Frame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day ]
    The medical research council was designed to examine the muscle strength. Six categories are included in the medical research council: 5 (muscle contracts normally against full resistance), 4 (muscle strength is reduced but muscle contraction can still move joint against resistance), 3 (muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. As an example, the elbow can be moved from full extension to full flexion starting with the arm hanging down at the side), 2 (muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane), 1 (only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle) and 0 (no movement is observed)

  4. Trunk control test [ Time Frame: at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First stroke attack
  • Within 3 months after stroke onset
  • Supratentorial stroke
  • Unilateral stroke

Exclusion Criteria:

  • Bilateral stroke
  • infratentorial stroke
  • Cognitive disabilities or serious psychiatric illness.
  • Difficulty in walking due to orthopedic problems.

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): NCT02569190


Locations
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Korea, Republic of
Veterans Health Service Medical Center
Seoul, Gangdong-gu, Korea, Republic of, 05368
Sponsors and Collaborators
Veterans Health Service Medical Center, Seoul, Korea
Investigators
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Principal Investigator: Dae Hyun Kim, Master Veterans hospital, Seoul, Republic of Korea
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Responsible Party: Dae Hyun, Medical Doctor, Veterans Health Service Medical Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT02569190    
Other Study ID Numbers: 2015-05-008-002
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016