Robotic Locomotor Experience Applied to Parkinson's Disease

Phase 2

• Conditions: Parkinson's Disease
• Interventions: Device: Lokomat®; Device: Treadmill

• Registration Number: NCT01302184
• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Primary Completion: 2011-04
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-26
• Last Update Posted: 2011-09-27
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Lokomat®	Lokomat®
Control Group	Treadmill	Treadmill training

Primary Outcome Measures

Name	Time	Method
6 minute walking test	Enrollment, after training completion, 3 and 6 months after training completion	The subject has to walk the longest distance possible within 6 minutes.

Secondary Outcome Measures

Name	Time	Method
10 meter walking test	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	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

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria "Maggiore della Carità"; 🇮🇹 Novara, Italy