This trial is active, not recruiting.

Condition parkinson's disease
Treatments lokomat®, treadmill
Phase phase 2/phase 3
Sponsor Azienda Ospedaliero Universitaria Maggiore della Carita
Start date October 2010
End date April 2011
Trial size 28 participants
Trial identifier NCT01302184, ROLEP


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
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)
Treadmill training
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.

Primary Outcomes

6 minute walking test
time frame: Enrollment, after training completion, 3 and 6 months after training completion

Secondary Outcomes

10 meter walking test
time frame: Enrollment, after training completion, 3 and 6 months after training completion
Time Up and Go test
time frame: Enrollment, after training completion, 3 and 6 months after training completion

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Robotic Locomotor Experience Applied to Parkinson's Disease (ROLEP)
Principal investigator Stefano Carda, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Azienda Ospedaliero Universitaria Maggiore della Carita.