Parkinson's DiseaseNCT02594540
Effects of the Mechanical Peripheral Stimulation for Parkinson's Disease Rehabilitation
A study testing Mechanical Peripheral Stimulation (GONDOLA) in people with Parkinson's Disease, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Mechanical Peripheral Stimulation (GONDOLA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Ciências da Saúde de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
About this study
Official title: Effects of the Mechanical Peripheral Stimulation for Parkinson's Disease Rehabilitation - A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Mechanical Peripheral Stimulation (GONDOLA)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Peripheral Stimulation (GONDOLA)Device
Also called GONDOLA equipment (Ecker Technologies Sagl, Switzerland)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: Mechanical Peripheral Stimulation (GONDOLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinetic and kinematic gait analysis
Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400).
Measured: 4 weeks of treatment
Secondary outcomes (8)
Risk of falls
Evaluated by means of the Timed Up \& Go Test (TUG).
Measured: 4 weeks of treatment
Motor impairment
Evaluated by means of the Unified Parkinson Disease Rating Scale (UPDRS III).
Measured: 4 weeks of treatment
Level of depression
Evaluated by means of the Beck Depression Inventory (BDI).
Measured: 4 weeks of treatment
Symptoms of Parkinson's disease progress
Evaluated by means of the Hoehn and Yahr scale.
Measured: 4 weeks of treatment
Serum levels of BDNF
Analyzed in blood sampling.
Measured: 4 weeks of treatment
Sensorio-motor connectivity
Functional magnetic resonance imaging.
Measured: 4 weeks of treatment
Lymphocyte Proliferation Assessment
Analyzed in blood sampling.
Measured: 4 weeks of treatment
Cytokine and Cortisol Assessment
Analyzed in blood sampling.
Measured: 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Gondola Medical Devices, Politecnico di Milano
- Responsible party
- Principal investigator, Aline de Souza Pagnussat, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594540
- Sponsor's protocol ID
- APA2016
- Status last verified
- Jan 2017
- First submitted
- 30 Oct 2015
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29902470
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Mechanical Peripheral Stimulation for Parkinson's Disease Rehabilitation - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02594540
- Acronym / sponsor ID
- APA2016
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Collaborators
- Gondola Medical Devices, Politecnico di Milano
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feet Mechanical Stimulation | Experimental | Device: Mechanical Peripheral Stimulation (GONDOLA)The feet mechanical stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Intervention: Device: Foot Mechanical Stimulation (GONDOLA) |
| Sham Feet Mechanical Stimulation | Sham comparator | Device: Mechanical Peripheral Stimulation (GONDOLA)The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Intervention: Device: Foot Mechanical Stimulation (GONDOLA) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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);
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Peripheral Stimulation (GONDOLA)Also: GONDOLA equipment (Ecker Technologies Sagl, Switzerland) | Device | Feet Mechanical Stimulation, Sham Feet Mechanical Stimulation |
Primary outcome
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).
8 secondary outcomes
Risk of falls
Time frame: 4 weeks of treatment
Motor impairment
Time frame: 4 weeks of treatment
Level of depression
Time frame: 4 weeks of treatment
Symptoms of Parkinson's disease progress
Time frame: 4 weeks of treatment
Serum levels of BDNF
Time frame: 4 weeks of treatment
Sensorio-motor connectivity
Time frame: 4 weeks of treatment
Lymphocyte Proliferation Assessment
Time frame: 4 weeks of treatment
Cytokine and Cortisol Assessment
Time frame: 4 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Derived from this study: PubMed 29902470Kleiner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Peripheral Stimulation (GONDOLA) in people with Parkinson's Disease, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinetic and kinematic gait analysis (time frame: 4 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02594540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.