Robotic Locomotor Experience Applied to Parkinson's Disease

Parkinson's Disease Clinical Trial

— ROLEP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01302184
• Other study ID #: ROLEP
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: February 23, 2011
• Last updated: September 26, 2011
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: September 2011
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: October 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Lokomat®
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
• Treadmill
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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria "Maggiore della Carità"	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walking test	The subject has to walk the longest distance possible within 6 minutes.	Enrollment, after training completion, 3 and 6 months after training completion	No
Secondary	10 meter walking test	The subject has to walk for 16 meters; the maximal speed reached in the central 10 meter is recorded	Enrollment, after training completion, 3 and 6 months after training completion	No
Secondary	Time Up and Go test	The subject has to lift from a chair, walk 3 meters, then turns back and sits on the chair. The time required is recorded	Enrollment, after training completion, 3 and 6 months after training completion	No