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Completed

NCT Number: NCT02594540

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

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Mechanical Peripheral Stimulation (GONDOLA)

Device

Other names: GONDOLA equipment (Ecker Technologies Sagl, Switzerland)

Primary outcomes

  1. 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

  1. Risk of falls

    Time frame: 4 weeks of treatment

    Evaluated by means of the Timed Up & Go Test (TUG).

  2. Motor impairment

    Time frame: 4 weeks of treatment

    Evaluated by means of the Unified Parkinson Disease Rating Scale (UPDRS III).

  3. Level of depression

    Time frame: 4 weeks of treatment

    Evaluated by means of the Beck Depression Inventory (BDI).

  4. Symptoms of Parkinson's disease progress

    Time frame: 4 weeks of treatment

    Evaluated by means of the Hoehn and Yahr scale.

  5. Serum levels of BDNF

    Time frame: 4 weeks of treatment

    Analyzed in blood sampling.

  6. Sensorio-motor connectivity

    Time frame: 4 weeks of treatment

    Functional magnetic resonance imaging.

  7. Lymphocyte Proliferation Assessment

    Time frame: 4 weeks of treatment

    Analyzed in blood sampling.

  8. Cytokine and Cortisol Assessment

    Time frame: 4 weeks of treatment

    Analyzed in blood sampling.

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Collaborators

  • Gondola Medical Devices
  • Politecnico di Milano

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 3, 2015
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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