Robotic Locomotor Experience Applied to Parkinson's Disease

NCT01302184 | Unknown Phase 2

• 1 other identifier: ROLEP
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 10 meter walking test

  Enrollment, after training completion, 3 and 6 months after training completion

• Time Up and Go test

  Enrollment, after training completion, 3 and 6 months after training completion

Study Arms (2)

Experimental Group

EXPERIMENTAL

Lokomat®

Device: Lokomat®

Control Group

ACTIVE COMPARATOR

Treadmill training

Device: Treadmill

Interventions

Lokomat® DEVICE

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

Experimental Group

Treadmill DEVICE

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria "Maggiore della Carità"

Novara, 28100, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Carlo Cisari, MD

  University of Eastern Piedmont "A. Avogadro" - Dep. Clinical & Experimental Medicine

  STUDY DIRECTOR

• Stefano Carda, MD, PhD

  Azienda Ospedaliera-Universitaria "Maggiore della Carità" - Novara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 24, 2011
• Study Start: October 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 27, 2011

Record last verified: 2011-09

Locations

IT (1)