Robotic Locomotor Experience Applied to Parkinson's Disease

NCT ID: NCT01302184

Last Updated: 2011-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

Lokomat®

Group Type: EXPERIMENTAL

Lokomat®

Intervention Type: 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

Control Group

Treadmill training

Group Type: ACTIVE_COMPARATOR

Treadmill

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role: lead

Responsible Party

Azienda Ospedaliero Universitaria Maggiore della Carita

Principal Investigators

Carlo Cisari, MD

Role: STUDY_DIRECTOR

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

Stefano Carda, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera-Universitaria "Maggiore della Carità" - Novara

Locations

Azienda Ospedaliero-Universitaria "Maggiore della Carità"

Novara, , Italy

Countries

Italy

Other Identifiers

ROLEP

Identifier Type: -

Identifier Source: org_study_id