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

Parkinson Disease Clinical Trial

Official title:

Acute Effects of Automated Mechanical Peripheral Stimulation on Cardiovascular, Functional Capacity and Postural Control in Patients With Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05456282
• Other study ID #: 11180310
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: March 30, 2023

Study information

• Verified date: July 2022
• Source: Universidad Católica del Maule
• Contact: Antonio R Zamunér, PhD
• Phone: +56987447384
• Email: azamuner[@]ucm.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 30, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Automated mechanical peripheral stimulation
Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles
• SHAM
Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles

Locations

Country	Name	City	State
Chile	Universidad Católica del Maule - Campus San Miguel	Talca	Maule

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica del Maule

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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).	1 hour