Robotic Locomotor Experience Applied to Parkinson's Disease (ROLEP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01302184|
Recruitment Status : Unknown
Verified September 2011 by Azienda Ospedaliero Universitaria Maggiore della Carita.
Recruitment status was: Active, not recruiting
First Posted : February 24, 2011
Last Update Posted : September 27, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Device: Lokomat® Device: Treadmill||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Robotic Locomotor Experience Applied to Parkinson's Disease (ROLEP)|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||October 2011|
Experimental: Experimental Group
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
Active Comparator: Control Group
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.
- 6 minute walking test [ Time Frame: Enrollment, after training completion, 3 and 6 months after training completion ]The subject has to walk the longest distance possible within 6 minutes.
- 10 meter walking test [ Time Frame: Enrollment, after training completion, 3 and 6 months after training completion ]The subject has to walk for 16 meters; the maximal speed reached in the central 10 meter is recorded
- Time Up and Go test [ Time Frame: Enrollment, after training completion, 3 and 6 months after training completion ]The subject has to lift from a chair, walk 3 meters, then turns back and sits on the chair. The time required is recorded
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302184
|Azienda Ospedaliero-Universitaria "Maggiore della Carità"|
|Novara, Italy, 28100|
|Study Director:||Carlo Cisari, MD||University of Eastern Piedmont "A. Avogadro" - Dep. Clinical & Experimental Medicine|
|Principal Investigator:||Stefano Carda, MD, PhD||Azienda Ospedaliera-Universitaria "Maggiore della Carità" - Novara|