Robotic Locomotor Experience Applied to Parkinson's Disease

Study Overview
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Brief Summary
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Gait rehabilitation with treadmill has been reported to be useful in patients with Parkinson's disease. In the last years, interest in robotic devices for gait training has grew up for patients with different neurological disorders, since they minimize demands on physical therapists and may provide a more reliable and constant treatment. The aim of this study is to evaluate if robotic gait training with Lokomat® can improve walking more than conventional gait training with treadmill in patients affected by Parkinson's disease.

Official Title
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Robotic Locomotor Experience Applied to Parkinson's Disease (ROLEP)

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: Lokomat®
* Device: Treadmill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients affected by PD with a disease stage < III according to Hoehn and Yahr's classification and age < 75 years; absence of motor fluctuations; able to ambulate independently; no treadmill training for at least 6 months before the study. Exclusion Criteria: current levodopa therapy started more than 6 months before enrollment; medical or neurological pathology that contributed significantly to gait dysfunction, as musculoskeletal disease, severe osteoarthritis, peripheral neuropathy, previous lower limb joint replacement, cardiovascular disease (recent myocardial infarct, from less than 4 weeks or uncontrolled hypertension, with blood pressure > 180/110 at rest); hearth failure (NYHA >=3); orthostatic hypotension; body weight over 100 kg; respiratory disease; dementia; depression; uncorrected visual disturbances. patients that have undergone deep brain stimulation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: Experimental Group<br>Lokomat® | Device: Lokomat®<br>* Patients of the experimental group were trained at 50% of BWS for 15 minutes and 30% of BWS for 15 minutes on the Lokomat®. Treadmill speed was initiated at 1.5km/h and increased to 3.0km/h by increments of 0.5km/h as tolerated. A physical therapist supervised the treatment, adjusting treadmill speed and BWS. Treatment was performed for 3 days/week, for 4 weeks<br>|
| Active Comparator: Control Group<br>Treadmill training | Device: Treadmill<br>* Patients of the control group had 30 minutes of treadmill gait training. After having calculated the speed during 6MWT, the patient was trained on a treadmill (RHC770CE - RAM Medical srl). They were trained using 80% of the maximum speed that the patient reached during the test for the first week, 90% for the second week, 100% for the third and fourth week. A Physical Therapist provided auditory cueing and direct, continuous feed-back to the patient. Treatment was performed for 3 days/week, for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walking test | The subject has to walk the longest distance possible within 6 minutes. | Enrollment, after training completion, 3 and 6 months after training completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 meter walking test | The subject has to walk for 16 meters; the maximal speed reached in the central 10 meter is recorded | Enrollment, after training completion, 3 and 6 months after training completion | 
| Time Up and Go test | The subject has to lift from a chair, walk 3 meters, then turns back and sits on the chair. The time required is recorded | Enrollment, after training completion, 3 and 6 months after training completion |