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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mechanical Peripheral Stimulation (GONDOLA)
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Universidade Federal de Ciências da Saúde de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Feet Mechanical Stimulation

Sham Feet Mechanical Stimulation

Arm Description

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

The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Intervention: Device: Foot Mechanical Stimulation (GONDOLA)

Outcomes

Primary Outcome Measures

Kinetic and kinematic gait analysis
Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400).

Secondary Outcome Measures

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

Full Information

First Posted
October 30, 2015
Last Updated
January 11, 2017
Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Gondola Medical Devices, Politecnico di Milano
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1. Study Identification

Unique Protocol Identification Number
NCT02594540
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Gondola Medical Devices, Politecnico di Milano

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feet Mechanical Stimulation
Arm Type
Experimental
Arm Description
The feet mechanical stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Intervention: Device: Foot Mechanical Stimulation (GONDOLA)
Arm Title
Sham Feet Mechanical Stimulation
Arm Type
Sham Comparator
Arm Description
The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Intervention: Device: Foot Mechanical Stimulation (GONDOLA)
Intervention Type
Device
Intervention Name(s)
Mechanical Peripheral Stimulation (GONDOLA)
Other Intervention Name(s)
GONDOLA equipment (Ecker Technologies Sagl, Switzerland)
Primary Outcome Measure Information:
Title
Kinetic and kinematic gait analysis
Description
Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400).
Time Frame
4 weeks of treatment
Secondary Outcome Measure Information:
Title
Risk of falls
Description
Evaluated by means of the Timed Up & Go Test (TUG).
Time Frame
4 weeks of treatment
Title
Motor impairment
Description
Evaluated by means of the Unified Parkinson Disease Rating Scale (UPDRS III).
Time Frame
4 weeks of treatment
Title
Level of depression
Description
Evaluated by means of the Beck Depression Inventory (BDI).
Time Frame
4 weeks of treatment
Title
Symptoms of Parkinson's disease progress
Description
Evaluated by means of the Hoehn and Yahr scale.
Time Frame
4 weeks of treatment
Title
Serum levels of BDNF
Description
Analyzed in blood sampling.
Time Frame
4 weeks of treatment
Title
Sensorio-motor connectivity
Description
Functional magnetic resonance imaging.
Time Frame
4 weeks of treatment
Title
Lymphocyte Proliferation Assessment
Description
Analyzed in blood sampling.
Time Frame
4 weeks of treatment
Title
Cytokine and Cortisol Assessment
Description
Analyzed in blood sampling.
Time Frame
4 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Facility Information:
Facility Name
Universidade Federal de Ciências da Saúde de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90050-170
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
29902470
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.
Results Reference
derived

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

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