NCT02594540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

October 30, 2015

Last Update Submit

January 11, 2017

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Kinetic and kinematic gait analysis

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

    4 weeks of treatment

Secondary Outcomes (8)

  • Risk of falls

    4 weeks of treatment

  • Motor impairment

    4 weeks of treatment

  • Level of depression

    4 weeks of treatment

  • Symptoms of Parkinson's disease progress

    4 weeks of treatment

  • Serum levels of BDNF

    4 weeks of treatment

  • +3 more secondary outcomes

Study Arms (2)

Feet Mechanical Stimulation

EXPERIMENTAL

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

Device: Mechanical Peripheral Stimulation (GONDOLA)

Sham Feet Mechanical Stimulation

SHAM COMPARATOR

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

Device: Mechanical Peripheral Stimulation (GONDOLA)

Interventions

Mechanical Peripheral Stimulation (GONDOLA)DEVICE
Also known as: GONDOLA equipment (Ecker Technologies Sagl, Switzerland)
Feet Mechanical StimulationSham Feet Mechanical Stimulation

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Ciências da Saúde de Porto Alegre

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

Location

Related Publications (1)

  • 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.

    PMID: 29902470DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 3, 2015

Study Start

December 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

BR(1)