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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Automated mechanical peripheral stimulation
SHAM
Sponsored by
Universidad Católica del Maule
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad Católica del Maule - Campus San MiguelRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

AMPS first, then SHAM

SHAM first, then AMPS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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).

Full Information

First Posted
July 4, 2022
Last Updated
July 8, 2022
Sponsor
Universidad Católica del Maule
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1. Study Identification

Unique Protocol Identification Number
NCT05456282
Brief Title
Acute Effects of AMPS on Cardiovascular, Functional Capacity and Postural Control in Patients With Parkinson's Disease
Official Title
Acute Effects of Automated Mechanical Peripheral Stimulation on Cardiovascular, Functional Capacity and Postural Control in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica del Maule

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AMPS first, then SHAM
Arm Type
Experimental
Arm Description
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.
Arm Title
SHAM first, then AMPS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Automated mechanical peripheral stimulation
Other Intervention Name(s)
Mechanical somatosensory stimulation, Gondola
Intervention Description
Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles
Intervention Type
Device
Intervention Name(s)
SHAM
Intervention Description
Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles
Primary Outcome Measure Information:
Title
Timed up and go
Description
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).
Time Frame
1 hour
Title
Center of Pressure
Description
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).
Time Frame
1 hour
Title
Heart rate variability
Description
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).
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Tinetti Test
Description
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).
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio R Zamunér, PhD
Phone
+56987447384
Email
azamuner@ucm.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio R Zamunér, PhD
Organizational Affiliation
Universidad Católica del Maule
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Católica del Maule - Campus San Miguel
City
Talca
State/Province
Maule
ZIP/Postal Code
3469001
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio R Zamunér, PHD
Phone
+56987447384
Email
azamuner@ucm.cl
First Name & Middle Initial & Last Name & Degree
Carolina Toloza
Phone
+56712986453

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participant data will be shared upon request at the end of the study.

Learn more about this trial

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

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