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Robot Assisted Gait Training in Patients With Infratentorial Stroke

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ClinicalTrials.gov Identifier: NCT02680691
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

Brief Summary:
The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke

Condition or disease Intervention/treatment Phase
Stroke Other: Robot, then conventional training Other: Conventional, then robot training Not Applicable

Detailed Description:
The hypothesis is to determine the robotic gait training would be better than conventional therapy regarding the postural balance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke
Study Start Date : April 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Robot, then conventional training
Robot assisted gait training 4 weeks after conventional gait training
Other: Robot, then conventional training
Robot assisted gait training from the baseline, then conventional gait training at 4 weeks after baseline

Active Comparator: Conventional, then robot training
Conventional gait training 4 weeks after robot assisted gait training
Other: Conventional, then robot training
Conventional gait training from the baseline, then robot assisted gait training at 4 weeks after baseline




Primary Outcome Measures :
  1. Change From Baseline in Berg Balance Scale at 4 Weeks [ Time Frame: Baseline and 4 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


Secondary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 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

  2. Trunk impairment scale [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 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

  3. Functional Ambulation Category [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline ]
    Categorizes patients according to basic motor skills necessary for functional ambulation. It represents the status of ambulation

  4. 10m walk test [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 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

  5. Fugl-Meyer Assessment [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline ]
    Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity

  6. Korean version of Falls efficacy scale [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline ]
    Asseses perception of balance and stability during activities of daily living Assesses fear of falling in the elderly population

  7. Scale for the assessment and rating of ataxia [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline ]
    Scale for the assessment and rating for infratentorial stroke

  8. Balance test using force plate [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline ]
    Each subject performs the following four tasks resembling Romberg test: standing with their feet positioning with the distance between their shoulders with eyes open (FSEO) or closed (FSEC), and standing with their feet together with eyes open (FTEO) or closed (FTEC). Each task is performed for 20 seconds and repeat for three times.



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

Inclusion Criteria:

  • Patients with infratentorial stroke
  • Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

  • chronic neurological pathology
  • orthopedic injuries
  • femur lengths of less than 34cm
  • severely limited range of lower extremity joint motion
  • medical instability

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): NCT02680691


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joon-Ho Shin, Team manager, National Rehabilitation Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT02680691     History of Changes
Other Study ID Numbers: NRC-2015-01-002
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea:
infratentorial stroke
robot
postural balance
Rehabilitation

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases