Parkinson Disease
Conditions
Brief summary
Considering that Parkinson's Disease (PD) can significantly compromise functional mobility and cardiovascular system in patients with PD, therapies aimed at improving these aspects, mainly by non-pharmacological and non-invasive methods, are paramount. This clinical trial will study the acute effects of plantar stimulation using a therapy called automated peripheral mechanical stimulation (AMPS) on cardiovascular and functional mobility in patients with PD. The hypothesis of this study is that one single session will be effective in improving, acutely, the cardiovascular system and functional capacity in patients with PD.
Interventions
Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles
DEVICESHAM
Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles
Sponsors
Universidad Católica del Maule
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants will randomly assigned to receive one of two alternative interventions (SHAM or AMPS) in the first session and the other intervention during the second visit. Participants will be assessed before and after each session.
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of idiopathic Parkinson's disease * Scoring 1 to 3 on the Hoehn and Yhar scale * Pharmacological treatment unchanged for at least 30 days prior the study
Exclusion criteria
* Signs of cognitive decline, based on the results of the Mini Mental State Examination * Cardiorespiratory, neuromuscular and musculoskeletal diseases not related to PD * Sensory peripheral neuropathy, diabetes or any other disease known to promote autonomic dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed up and go | 1 hour | Time spent for the participant to rise from a standard chair without armrests, walk 3 meters straight at their preferred speed, turn, walk back to the chair and sit down again. Participants will perform the test twice and the lowest total duration will be considered as the outcome. The outcome measure is assessed as a difference or change from baseline to immediately after the intervention (about 1 hour from baseline assessment). |
| Center of Pressure | 1 hour | Stabilometric variables of the center of pressure assessed using a 3D Force Plate (Kistler, US). Outcomes include anteroposterior and mediolateral velocity, root mean square and area) of the center of pressure. The outcome measure is assessed as a difference or change from baseline to immediately after the intervention (about 1 hour from baseline assessment). |
| Heart rate variability | 1 hour | R-R intervals (time between every electrocardiogram R waves) will be recorded using a Polar V800 (Polar Electro Oy, Finland) and its variability will be quantified using linear and nonlinear methods. The outcome measure is assessed as a difference or change from baseline to immediately after the intervention (about 1 hour from baseline assessment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tinetti Test | 1 hour | Participants will be asked to: 1) firmly sit on a chair without armrests for at least 10 s; 2) stand up freely and keep the position for at least 10 s; 3) close the eyes during orthostatic position for at least 5 s; 4) control balance keeping the eyes closed while nudged by the clinician; 5) open the eyes and maintain upright position for at least 10 s; 6) perform a 360º turn around himself/herself; 7) sit down on the chair; and 8) walk as straight as possible for at least 10 m. The Tinetti test total score ranges from 0 to 28. The lower the score on the Tinetti test, the lower the functional mobility and the higher the risk of falling. The outcome measure is assessed as a difference or change from baseline to immediately after the intervention (about 1 hour from baseline assessment). |
Countries
Chile
Contacts
PRINCIPAL_INVESTIGATORAntonio R Zamunér, PhD
Universidad Católica del Maule
Outcome results
None listed