Parkinson DiseaseNCT05456282
Acute Effects of AMPS on Cardiovascular, Functional Capacity and Postural Control in Patients With Parkinson's Disease
A study testing Automated mechanical peripheral stimulation in people with Parkinson Disease, run by Universidad Católica del Maule at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Automated mechanical peripheral stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 1 Dec 2019to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site
Universidad Católica del Maule - Campus San Miguel
Talca, Maule Region, 3469001
About this study
Official title: Acute Effects of Automated Mechanical Peripheral Stimulation on Cardiovascular, Functional Capacity and Postural Control in Patients With Parkinson's Disease
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.
- Conditions
- Parkinson Disease
- Being tested
- Automated mechanical peripheral stimulation, SHAM
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated mechanical peripheral stimulationDevice
Also called Mechanical somatosensory stimulation, Gondola
Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles
SHAMDevice
Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles
| Study group | Role | What they receive |
|---|---|---|
| AMPS first, then SHAM | Experimental | Participants will receive first one session of automated mechanical peripheral stimulation (AMPS) with intensity at the pain threshold. Then, after a 2-week washout, they will receive one session of a simulated automated mechanical peripheral stimulation (SHAM) with intensity at the sensory threshold. Receives: Device: Automated mechanical peripheral stimulation; Device: SHAM |
| SHAM first, then AMPS | Sham comparator | Participants will receive first one session of simulated automated mechanical peripheral stimulation (SHAM) with intensity at the sensory threshold. Then, after a 2-week washout, they will receive one session of automated mechanical peripheral stimulation (AMPS) with intensity at the pain threshold. Receives: Device: Automated mechanical peripheral stimulation; Device: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and go
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).
Measured: 1 hour
Center of Pressure
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).
Measured: 1 hour
Heart rate variability
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).
Measured: 1 hour
Secondary outcomes (1)
Tinetti Test
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).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Dec 2019
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica del Maule
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Roberto Zamunér, Universidad Católica del Maule
- Investigators
- Antonio R Zamunér, PhD, Principal investigator, Universidad Católica del Maule
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456282
- Sponsor's protocol ID
- 11180310
- Status last verified
- Apr 2026
- First submitted
- 4 Jul 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be shared upon request at the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Automated Mechanical Peripheral Stimulation on Cardiovascular, Functional Capacity and Postural Control in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05456282
- Acronym / sponsor ID
- 11180310
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Católica del MauleUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| AMPS first, then SHAM | Experimental | Device: Automated mechanical peripheral stimulation, Device: SHAMParticipants will receive first one session of automated mechanical peripheral stimulation (AMPS) with intensity at the pain threshold. Then, after a 2-week washout, they will receive one session of a simulated automated mechanical peripheral stimulation (SHAM) with intensity at the sensory threshold. |
| SHAM first, then AMPS | Sham comparator | Device: Automated mechanical peripheral stimulation, Device: SHAMParticipants will receive first one session of simulated automated mechanical peripheral stimulation (SHAM) with intensity at the sensory threshold. Then, after a 2-week washout, they will receive one session of automated mechanical peripheral stimulation (AMPS) with intensity at the pain threshold. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated mechanical peripheral stimulationAlso: Mechanical somatosensory stimulation, GondolaAutomated mechanical pressure reaching the pain threshold in four specific points at the foots soles | Device | AMPS first, then SHAM, SHAM first, then AMPS |
| SHAMAutomated mechanical pressure reaching the sensory threshold in four specific points at the foots soles | Device | AMPS first, then SHAM, SHAM first, then AMPS |
Primary outcome
Timed up and go
Time frame: 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
Time frame: 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
Time frame: 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).
1 secondary outcome
Tinetti Test
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. Participant data will be shared upon request at the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio R Zamunér, PhD principal investigator
Universidad Católica del Maule
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated mechanical peripheral stimulation in people with Parkinson Disease, run by Universidad Católica del Maule at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up and go (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.