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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2023-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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AMPS first, then SHAM

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.

Group Type EXPERIMENTAL

Automated mechanical peripheral stimulation

Intervention Type DEVICE

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

SHAM

Intervention Type DEVICE

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

SHAM first, then AMPS

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.

Group Type SHAM_COMPARATOR

Automated mechanical peripheral stimulation

Intervention Type DEVICE

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

SHAM

Intervention Type DEVICE

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

Interventions

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Automated mechanical peripheral stimulation

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

Intervention Type DEVICE

SHAM

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

Intervention Type DEVICE

Other Intervention Names

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Mechanical somatosensory stimulation Gondola

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No