Effects of Locomotion Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Subacute Stroke
NCT ID: NCT01726998
Last Updated: 2014-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2012-03-31
2013-05-31
Brief Summary
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72 first-ever stroke patients who could not walk independently (FAC \< 2), and suffered within 6 months were enrolled and randomly assigned into 2 groups. The subjects with congestive heart failure, malignancies, cardiopulmonary dysfunctions, and who could not walk independently before stroke attack were excluded.
Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment (NDT) basically. The robotic assisted locomotor training group received additional robotic-assisted gait therapy for 30minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods. The independent walking ability(FAC ≥ 3), Functional Ambulation Category (FAC), Motricity index (MI), Fugl-Meyer assessment (FMA), Modified Barthel Index (MBI), Medical Research Council (MRC) for each lower extremity muscles were assessed before, during (2weeks) and after training. And the independent walking ability were followed until 3 months.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lokomat Group
Robot-assisted gait therapy
Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically. Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.
conventional gait training group
conventional gait training
Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically. Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.
Interventions
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Robot-assisted gait therapy
Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically. Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.
conventional gait training
Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically. Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.
Eligibility Criteria
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Inclusion Criteria
2. No other neurologic or orthopedic disorder
3. Independent ambulation before the stroke
4. No severe medical illnesses
5. Hemiparesis: lower extremity strength graded ≤ 3 in more than 2 muscle groups
6. Functional ambulation classification (FAC) ≤ 1 : indicating a need for personal assistance in ambulation
7. The interval between stroke and start of the treatment
8. Time since stroke onset \< 6 months
9. age: 20-80yrs old
Exclusion Criteria
2. Severe osteoporosis
3. Severe skin problems
4. Severe joint problems
5. Major difference in leg length,
6. Body weight over 130 kg,
7. Orthostatic circulatory problem
8. Severe cognitive impairment
20 Years
80 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Severance hospital
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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4-2012-0005
Identifier Type: -
Identifier Source: org_study_id
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