Acute Effects of AMPS on Cardiovascular, Functional Capacity and Postural Control in Patients With Parkinson's Disease

NCT05456282 | Completed

• 1 other identifier: 11180310
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  1 hour

Secondary Outcomes (1)

• Tinetti Test

  1 hour

Study Arms (2)

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.

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.

Device: Automated mechanical peripheral stimulation; Device: SHAM

Interventions

Automated mechanical peripheral stimulation DEVICE

Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles

Also known as: Mechanical somatosensory stimulation, Gondola

AMPS first, then SHAM; SHAM first, then AMPS

SHAM DEVICE

Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles

AMPS first, then SHAM; SHAM first, then AMPS

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Católica del Maule: lead

Study Sites (1)

Universidad Católica del Maule - Campus San Miguel

Talca, Maule Region, 3469001, Chile

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Antonio R Zamunér, PhD

  Universidad Católica del Maule

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 13, 2022
• Study Start: December 1, 2019
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)