Effects of the Mechanical Peripheral Stimulation for Parkinson's Disease Rehabilitation

Federal University of Health Science of Porto Alegre

Status: Completed

Conditions: Parkinson's Disease

Treatments: Device: Mechanical Peripheral Stimulation (GONDOLA)

Study type: Interventional

Funder types: Other

Identifiers

NCT02594540

APA2016

Details and patient eligibility

About

The purpose of this study is to evaluate safety and effectiveness of the peripheral mechanical stimulation of the feet on gait variables, clinical status, risk of falls, BDNF levels, immunological profile and brain functional connectivity changes in patients with Parkinson's disease.

Full description

Patients will be submitted to 8 sessions of peripheral mechanical stimulation of the feet or sham stimulation along 4 weeks.

Evaluations will be performed before and after the first session, after the forth and the eighth session.

Enrollment: 28 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of idiopathic Parkinson's disease based on clinical criteria, dopamine transporter (DaT) scans and/or magnetic resonance imaging;
• Able to walk 25 feet unassisted or with minimal assistance;
• Presenting freezing of gait;
• Aged between 50-85 years;
• Minimum score of 20 in the Mini Mental State Examination (MMSE);

Exclusion criteria

• Secondary musculoskeletal disorder involving the lower limb, as chondral injuries, ligament and ankle sprains which may impede the realization of the gait by pain or motion disability;
• Peripheral neuropathy;
• Not attending all the treatment;
• Absolute contraindications for fMRI (just for fMRI examination);
• Presence of deep brain stimulation;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups

Feet Mechanical Stimulation

Experimental group

Description:

The feet mechanical stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Intervention: Device: Foot Mechanical Stimulation (GONDOLA)

Treatment:

Device: Mechanical Peripheral Stimulation (GONDOLA)

Sham Feet Mechanical Stimulation

Sham Comparator group

Description:

The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Intervention: Device: Foot Mechanical Stimulation (GONDOLA)

Treatment:

Device: Mechanical Peripheral Stimulation (GONDOLA)