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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier:
NCT01302184
First received: February 23, 2011
Last updated: September 26, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
 Device: Lokomat®
Device: Treadmill
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robotic Locomotor Experience Applied to Parkinson's Disease (ROLEP)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliero Universitaria Maggiore della Carita:

Primary Outcome Measures:
  • 6 minute walking test [ Time Frame: Enrollment, after training completion, 3 and 6 months after training completion ] [ Designated as safety issue: No ]
    The subject has to walk the longest distance possible within 6 minutes.


Secondary Outcome Measures:
  • 10 meter walking test [ Time Frame: Enrollment, after training completion, 3 and 6 months after training completion ] [ Designated as safety issue: No ]
    The subject has to walk for 16 meters; the maximal speed reached in the central 10 meter is recorded

  • Time Up and Go test [ Time Frame: Enrollment, after training completion, 3 and 6 months after training completion ] [ Designated as safety issue: No ]
    The subject has to lift from a chair, walk 3 meters, then turns back and sits on the chair. The time required is recorded


Estimated Enrollment: 28
Study Start Date: October 2010
Estimated Study Completion Date: October 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302184

Locations
Italy
Azienda Ospedaliero-Universitaria "Maggiore della Carità"
Novara, Italy, 28100
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Carlo Cisari, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT01302184     History of Changes
Other Study ID Numbers: ROLEP
Study First Received: February 23, 2011
Last Updated: September 26, 2011
Health Authority: Italy: National Institute of Health

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 21, 2013