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

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Device: Mechanical Peripheral Stimulation (GONDOLA)

• Registration Number: NCT02594540
• Lead Sponsor: Federal University of Health Science of Porto Alegre

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.

Study Timeline

• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-03
• Study Start: 2015-12
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universidade Federal de Ciências da Saúde de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil