Effects of Locomotion Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Subacute Stroke

Study Overview
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Brief Summary
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The investigators aimed in this study to investigate the effects of 4 weeks robot-assisted locomotor training on motor recovery of lower extremities and walking ability compared with the conventional gait training in subacute post-stroke non-ambulatory hemiplegic patients. 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.

Conditions
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Stroke, Hemiparetic Patients After Subacute Stroke

Intervention / Treatment
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* Other: Robot-assisted gait therapy
* Other: conventional gait training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemiparesis as result of 1st stroke No other neurologic or orthopedic disorder Independent ambulation before the stroke No severe medical illnesses Hemiparesis: lower extremity strength graded ≤ 3 in more than 2 muscle groups Functional ambulation classification (FAC) ≤ 1 : indicating a need for personal assistance in ambulation The interval between stroke and start of the treatment Time since stroke onset < 6 months age: 20-80yrs old Exclusion Criteria: Unstable fractures Severe osteoporosis Severe skin problems Severe joint problems Major difference in leg length, Body weight over 130 kg, Orthostatic circulatory problem Severe cognitive impairment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lokomat Group<br> | Other: Robot-assisted gait therapy<br>* 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.<br>|
| Active Comparator: conventional gait training group<br> | Other: conventional gait training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of functional ambulation category point | FAC is a functional walking test that evaluates ambulation ability. This is an 6-point scale. | baseline, during training (2weeks), post training (4weeks) & followed for 2months after training |