NCT02594540CompletedNot Applicable
Effects of the Mechanical Peripheral Stimulation for Parkinson's Disease Rehabilitation - A Randomized Clinical Trial
Federal University of Health Science of Porto Alegre2 sites in 1 country28 target enrollmentStarted: December 1, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Kinetic and kinematic gait analysis
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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;
Outcomes
Primary Outcomes
Kinetic and kinematic gait analysis
Time Frame: 4 weeks of treatment
Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400).
Secondary Outcomes
- Symptoms of Parkinson's disease progress(4 weeks of treatment)
- Serum levels of BDNF(4 weeks of treatment)
- Cytokine and Cortisol Assessment(4 weeks of treatment)
- Sensorio-motor connectivity(4 weeks of treatment)
- Risk of falls(4 weeks of treatment)
- Motor impairment(4 weeks of treatment)
- Level of depression(4 weeks of treatment)
- Lymphocyte Proliferation Assessment(4 weeks of treatment)
Investigators
Aline de Souza Pagnussat
PhD
Federal University of Health Science of Porto Alegre
Study Sites (2)
Loading locations...
Similar Trials
Unknown
Not Applicable
Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and STN-DBSGait Disorders, NeurologicParkinson DiseaseNCT04831879Gondola Medical Technologies SA40
Terminated
Not Applicable
SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) PatientsFailed Back Surgery SyndromeNCT01711619MedtronicNeuro162
Completed
Phase 2
Functional Electrical Stimulation of Peripheral Muscles in Heart Failure With Preserved Left Ventricular Ejection FractionHeart Failure With Preserved Left Ventricular Ejection FractionNCT01829607Attikon Hospital30
Not yet recruiting
Phase 4
The effectiveness of peripheral magnetic stimulation combined with conventional therapy in moderate degree carpal tunnel syndrome : a randomized, assessor blinded, controlled trialModerate degree of carpal tunnel syndromeperipheral magnetic stimulationconventional therapyelectrodiagnosiscarpal tunnel syndromeTCTR20230405001/A60
Completed
Not Applicable
Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)Back PainLow Back PainNCT03179202SPR Therapeutics, Inc.166