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

Universidad Católica del Maule

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: SHAM; Device: Automated mechanical peripheral stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05456282

11180310

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups

AMPS first, then SHAM

Experimental group

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.

Treatment:

Device: Automated mechanical peripheral stimulation

Device: SHAM

SHAM first, then AMPS

Sham Comparator group

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.

Treatment:

Device: Automated mechanical peripheral stimulation

Device: SHAM