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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594540
• Other study ID #: APA2016
• Status: Completed
• Phase: N/A
• First received: October 30, 2015
• Last updated: January 11, 2017
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Mechanical Peripheral Stimulation (GONDOLA)

Locations

Country	Name	City	State
Brazil	Universidade Federal de Ciências da Saúde de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre	Gondola Medical Devices, Politecnico di Milano

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinetic and kinematic gait analysis	Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400).	4 weeks of treatment	Yes
Secondary	Risk of falls	Evaluated by means of the Timed Up & Go Test (TUG).	4 weeks of treatment	Yes
Secondary	Motor impairment	Evaluated by means of the Unified Parkinson Disease Rating Scale (UPDRS III).	4 weeks of treatment	Yes
Secondary	Level of depression	Evaluated by means of the Beck Depression Inventory (BDI).	4 weeks of treatment	Yes
Secondary	Symptoms of Parkinson's disease progress	Evaluated by means of the Hoehn and Yahr scale.	4 weeks of treatment	No
Secondary	Serum levels of BDNF	Analyzed in blood sampling.	4 weeks of treatment	No
Secondary	Sensorio-motor connectivity	Functional magnetic resonance imaging.	4 weeks of treatment	Yes
Secondary	Lymphocyte Proliferation Assessment	Analyzed in blood sampling.	4 weeks of treatment	No
Secondary	Cytokine and Cortisol Assessment	Analyzed in blood sampling.	4 weeks of treatment	No