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Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients (Walkbot)

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ClinicalTrials.gov Identifier: NCT02694302
Recruitment Status : Completed
First Posted : February 29, 2016
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
P&S Mechanics Co., Ltd.

Brief Summary:
A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.

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

Detailed Description:

Robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.

Experimental group receives robot-assisted-gait-training and conventional gait training.

Active comparator group receives conventional gait training only as the same number as the experimental group.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Parallel and Randomized Design Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients to Evaluate Its Efficacy, Safety and Superiority Over Conventional Gait Training
Study Start Date : March 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: Walkbot
Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.
Device: Walkbot
Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.

Device: Conventional physical therapy
Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.

Active Comparator: Conventional physical therapy
Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
Device: Conventional physical therapy
Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.




Primary Outcome Measures :
  1. Functional Ambulation Category(FAC) [ Time Frame: 9 weeks from baseline ]

Secondary Outcome Measures :
  1. Motricity Index(MI) [ Time Frame: 9 weeks from baseline ]
  2. 10 Meter Walk Test(10MWT) [ Time Frame: 9 weeks from baseline ]
  3. 6 Minute Walk Test(6MWT) [ Time Frame: 9 weeks from baseline ]
  4. Medical Research Council(MRC) Scale [ Time Frame: 9 weeks from baseline ]
  5. Modified Ashworth Scale (MAS) [ Time Frame: 9 weeks from baseline ]
  6. Fugl-Meyer Assessment(FMA) of Motor Recovery after Stroke [ Time Frame: 9 weeks from baseline ]
  7. Modified Barthel Index(MBI) [ Time Frame: 9 weeks from baseline ]
  8. National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 9 weeks from baseline ]
  9. Beck's Depression Inventory test (BDI) [ Time Frame: 9 weeks from baseline ]
  10. Treatment Satisfaction Survey [ Time Frame: 9 weeks from baseline ]


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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:

  • Age more than 19 and under 80
  • Weight under 100kg
  • Height less than 200cm
  • Able to walk independently before onset of stroke
  • Ischemic or hemorrhagic stroke patients
  • Patients with motor paralysis and gait disturbance after stroke and seeking rehabilitation treatment
  • FAC(Functional Ambulation Category) under 3 (0~2)
  • Subacute stroke patients after 3 days and before 3 months of onset
  • Be informed of the nature of the study and agreed on written consent voluntarily
  • Patients taking medications or scheduled medications due to stroke

Exclusion Criteria:

  • Patients with contraindications to weight bearing such as fractures, etc.
  • Uncontrolled stage 2 hypertension (systolic over 160 mmHg or diastolic more than 100mmHg) or with uncontrolled orthostatic hypotension
  • Patients with cardiopulmonary disease or other underlying diseases that can not tolerate gait training
  • Patients with severe skin damage and bedsore on wearing part of the trial device
  • Pregnant or breast-feeding
  • Participation within 30 days of the other clinical trials
  • Patients whom the investigator considers inappropriate to participate in the study

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): NCT02694302


Locations
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Korea, Republic of
National Rehabilitation Center
Seoul, Korea, Republic of, 01022
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
P&S Mechanics Co., Ltd.
Investigators
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Principal Investigator: Jung Hwan Kim, MD, PhD National Rehabilitation Center, Korea

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Responsible Party: P&S Mechanics Co., Ltd.
ClinicalTrials.gov Identifier: NCT02694302     History of Changes
Other Study ID Numbers: UMT2013-PS-WB-01
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by P&S Mechanics Co., Ltd.:
Stroke

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