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

Azienda Ospedaliero Universitaria Maggiore della Carita1 site in 1 country28 target enrollmentOctober 2010

ConditionsParkinson's Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Parkinson's Disease
Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Enrollment: 28
Locations: 1
Primary Endpoint: 6 minute walking test
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

October 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

10 meter walking test(Enrollment, after training completion, 3 and 6 months after training completion)
Time Up and Go test(Enrollment, after training completion, 3 and 6 months after training completion)