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

University Hospital Maggiore della Carità of Novara

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Parkinson's Disease

Treatments

Device: Lokomat®

Device: Treadmill

Study type

Interventional

Funder types

Other

Identifiers

NCT01302184

ROLEP

Details and patient eligibility

About

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.

Enrollment

28 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.