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

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Lokomat®
Treadmill
Sponsored by
Azienda Ospedaliero Universitaria Maggiore della Carita
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Azienda Ospedaliero-Universitaria "Maggiore della Carità"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Lokomat®

Treadmill training

Outcomes

Primary Outcome Measures

6 minute walking test
The subject has to walk the longest distance possible within 6 minutes.

Secondary Outcome Measures

10 meter walking test
The subject has to walk for 16 meters; the maximal speed reached in the central 10 meter is recorded
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

Full Information

First Posted
February 23, 2011
Last Updated
September 26, 2011
Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
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1. Study Identification

Unique Protocol Identification Number
NCT01302184
Brief Title
Robotic Locomotor Experience Applied to Parkinson's Disease
Acronym
ROLEP
Official Title
Robotic Locomotor Experience Applied to Parkinson's Disease (ROLEP)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Lokomat®
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Treadmill training
Intervention Type
Device
Intervention Name(s)
Lokomat®
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Treadmill
Intervention Description
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.
Primary Outcome Measure Information:
Title
6 minute walking test
Description
The subject has to walk the longest distance possible within 6 minutes.
Time Frame
Enrollment, after training completion, 3 and 6 months after training completion
Secondary Outcome Measure Information:
Title
10 meter walking test
Description
The subject has to walk for 16 meters; the maximal speed reached in the central 10 meter is recorded
Time Frame
Enrollment, after training completion, 3 and 6 months after training completion
Title
Time Up and Go test
Description
The subject has to lift from a chair, walk 3 meters, then turns back and sits on the chair. The time required is recorded
Time Frame
Enrollment, after training completion, 3 and 6 months after training completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Cisari, MD
Organizational Affiliation
University of Eastern Piedmont "A. Avogadro" - Dep. Clinical & Experimental Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stefano Carda, MD, PhD
Organizational Affiliation
Azienda Ospedaliera-Universitaria "Maggiore della Carità" - Novara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero-Universitaria "Maggiore della Carità"
City
Novara
ZIP/Postal Code
28100
Country
Italy

12. IPD Sharing Statement

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Robotic Locomotor Experience Applied to Parkinson's Disease

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