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

Effects of the Mechanical Peripheral Stimulation for Parkinson's Disease Rehabilitation - A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Mechanical Peripheral Stimulation (GONDOLA)

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
      • Universidade Federal de Ciências da Saúde de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feet Mechanical Stimulation; The feet mechanical stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Intervention: Device: Foot Mechanical Stimulation (GONDOLA)	Device: Mechanical Peripheral Stimulation (GONDOLA); Other Names: GONDOLA equipment (Ecker Technologies Sagl, Switzerland)
Sham Comparator: Sham Feet Mechanical Stimulation; The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Intervention: Device: Foot Mechanical Stimulation (GONDOLA)	Device: Mechanical Peripheral Stimulation (GONDOLA); Other Names: GONDOLA equipment (Ecker Technologies Sagl, Switzerland)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinetic and kinematic gait analysis	Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400).	4 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of falls	Evaluated by means of the Timed Up & Go Test (TUG).	4 weeks of treatment
Motor impairment	Evaluated by means of the Unified Parkinson Disease Rating Scale (UPDRS III).	4 weeks of treatment
Level of depression	Evaluated by means of the Beck Depression Inventory (BDI).	4 weeks of treatment
Symptoms of Parkinson's disease progress	Evaluated by means of the Hoehn and Yahr scale.	4 weeks of treatment
Serum levels of BDNF	Analyzed in blood sampling.	4 weeks of treatment
Sensorio-motor connectivity	Functional magnetic resonance imaging.	4 weeks of treatment
Lymphocyte Proliferation Assessment	Analyzed in blood sampling.	4 weeks of treatment
Cytokine and Cortisol Assessment	Analyzed in blood sampling.	4 weeks of treatment

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Collaborators: Politecnico di Milano; Gondola Medical Devices

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 30, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Estimate): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: APA2016