Comparison Of Two Different Type Robot Assisted Gait Training In Rehabilitation Of Stroke

Study Overview
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Brief Summary
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Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp)

Detailed Description
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There are different types of devices in robotic rehabilitation which has been used in recent years for stroke. Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp) in robot-assisted gait training of stroke rehabilitation

Official Title
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Comparison Of An Exoskeleton Device With An End-Effector Device In Robotic Gait Assesment Of Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: robot-assisted gait training
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rehabilitation need for stroke Patients under FAC stage 4 No contraindications for robotic rehabilitation Subacute stroke Exclusion Criteria: The robot-orthosis does not fit the patient's body Inadequate body weight (obesity) Severe contractures Bone instability (nonstable spinal cord fracture and severe osteoporosis) Circulation problems Cardiac problems Open wounds on the lower extremities or in the body where they will come into contact with the orthosis Uncoordinated, psychotic or aggressive patients Serious cognitive disorders Patients with long-term infusion therapy Hip, knee, ankle arthrodesis Epilepsy Patients with disproportionate limb or vertebrae, such as bone cartilage dysplasia Those with severe vascular problems of the lower extremity Conditions requiring rest or immobilization, such as osteomyelitis and other inflammatory/infectious diseases Severe respiratory diseases

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: End-effector<br>For stroke rehabilitation 5 days a week in addition to conventional treatment methods robot-assisted gait training(end-effector type-Lokohelp) will be taken with 45 minutes a day for 3 days a week for 4 weeks. Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level. | Other: robot-assisted gait training<br>* Investigators will use robot-assisted gait training for rehabilitation of stroke<br>|
| Active Comparator: Exoskeleton<br>For stroke rehabilitation 5 days a week in addition to conventional treatment methods robot-assisted gait training (exoskeleton type-Robogait) will be taken with 45 minutes a day for 3 days a week for 4 weeks. Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level. | Other: robot-assisted gait training<br>* Investigators will use robot-assisted gait training for rehabilitation of stroke<br>|
| Placebo Comparator: conventional treatment<br>conventional treatment methods for stroke rehabilitation 5 days a week Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level. | Other: placebo<br>* Investigators will use only conventional treatment without robot-assisted gait training<br>* Other names: conventional treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk test | 6 minute walk test for walking speed | 4 weeks | 
| 10 meter walking test | 10 meter walking test for walking | 4 weeks | 
| Postural Assessment Scale for Stroke(PASS) | Postural Assessment Scale for Stroke(PASS) will be used | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FAC(Functional Ambulation Classification) | FAC will be used for ambulation | 4 weeks | 
| Barthel Index | Barthel Index will be used for daily living activities | 4 weeks |