Effects of Locomotion Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Subacute Stroke
Primary Purpose
Stroke, Hemiparetic Patients After Subacute Stroke
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Robot-assisted gait therapy
conventional gait training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Severance hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lokomat Group
conventional gait training group
Arm Description
Outcomes
Primary Outcome Measures
change of functional ambulation category point
FAC is a functional walking test that evaluates ambulation ability. This is an 6-point scale.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01726998
Brief Title
Effects of Locomotion Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Subacute Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparetic Patients After Subacute Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lokomat Group
Arm Type
Experimental
Arm Title
conventional gait training group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Robot-assisted gait therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional gait training
Intervention Description
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.
Primary Outcome Measure Information:
Title
change of functional ambulation category point
Description
FAC is a functional walking test that evaluates ambulation ability. This is an 6-point scale.
Time Frame
baseline, during training (2weeks), post training (4weeks) & followed for 2months after training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effects of Locomotion Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Subacute Stroke
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