Clinical trial NCT02594540: Effects of the Mechanical Peripheral Stimulation for Parkinson's Disease Rehabilitation
Official title: Effects of the Mechanical Peripheral Stimulation for Parkinson's Disease Rehabilitation - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Gondola Medical Devices
name: Politecnico di Milano
First posted: 2015-11-03
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Kinetic and kinematic gait analysis
timeFrame: 4 weeks of treatment
Secondary outcomes:
measure: Risk of falls
timeFrame: 4 weeks of treatment
measure: Motor impairment
timeFrame: 4 weeks of treatment
measure: Level of depression
timeFrame: 4 weeks of treatment
measure: Symptoms of Parkinson's disease progress
timeFrame: 4 weeks of treatment
measure: Serum levels of BDNF
timeFrame: 4 weeks of treatment
measure: Sensorio-motor connectivity
timeFrame: 4 weeks of treatment
measure: Lymphocyte Proliferation Assessment
timeFrame: 4 weeks of treatment
measure: Cytokine and Cortisol Assessment
timeFrame: 4 weeks of treatment
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal de Ciências da Saúde de Porto Alegre
state: Rio Grande do Sul
Study officials:
References:
citation: Kleiner AFR, Souza Pagnussat A, Pinto C, Redivo Marchese R, Salazar AP, Galli M. Automated Mechanical Peripheral Stimulation Effects on Gait Variability in Individuals With Parkinson Disease and Freezing of Gait: A Double-Blind, Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Dec;99(12):2420-2429. doi: 10.1016/j.apmr.2018.05.009. Epub 2018 Jun 11.