Parkinson's Disease
Conditions
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.
Interventions
DEVICELokomat®
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
DEVICETreadmill
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.
Sponsors
Azienda Ospedaliero Universitaria Maggiore della Carita
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 minute walking test | Enrollment, after training completion, 3 and 6 months after training completion | The subject has to walk the longest distance possible within 6 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 10 meter walking test | Enrollment, after training completion, 3 and 6 months after training completion | The subject has to walk for 16 meters; the maximal speed reached in the central 10 meter is recorded |
| Time Up and Go test | Enrollment, after training completion, 3 and 6 months after training completion | The subject has to lift from a chair, walk 3 meters, then turns back and sits on the chair. The time required is recorded |
Countries
Italy
Outcome results
None listed