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

Robotic Locomotor Experience Applied to Parkinson's Disease (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.

Study Overview

• Status: Unknown
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Lokomat®; Device: Treadmill

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Italy
  • Novara, Italy, 28100
    • Azienda Ospedaliero-Universitaria "Maggiore della Carità"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Lokomat®	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
Active Comparator: Control Group; Treadmill training	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
• Investigators: Study Director: Carlo Cisari, MD, University of Eastern Piedmont "A. Avogadro" - Dep. Clinical & Experimental Medicine; Principal Investigator: Stefano Carda, MD, PhD, Azienda Ospedaliera-Universitaria "Maggiore della Carità" - Novara

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): September 27, 2011
• Last Update Submitted That Met QC Criteria: September 26, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: ROLEP