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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Feet Mechanical Stimulation on Cardiovascular Autonomic Profile and Inflammation in Parkinson's Disease

NCT02608424

Parkinson's Disease Autonomic Neuropathy Inflammation +1 more

COMPLETED NA

Treadmill in the Rehabilitation of Parkinsonian Gait

NCT03815409

Parkinson's Disease

COMPLETED NA

Analysis of Postural Transitions in Subjects Affected by Parkinson Disease

NCT05329987

Parkinson Disease

COMPLETED

Analysis of the Parameters Obtained on Stabilometric Platform in Patients With PD

NCT02098655

Parkinson's Disease Disturbance; Balance, Labyrinth Other Falls

UNKNOWN

Mental Practice Combined With Physical Practice to Improve the Gait Performance of People With Parkinson's Disease

NCT02904837

Parkinson Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Feet Mechanical Stimulation

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

Group Type EXPERIMENTAL

Mechanical Peripheral Stimulation (GONDOLA)

Intervention Type DEVICE

Sham Feet Mechanical Stimulation

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

Group Type SHAM_COMPARATOR

Mechanical Peripheral Stimulation (GONDOLA)

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mechanical Peripheral Stimulation (GONDOLA)

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GONDOLA equipment (Ecker Technologies Sagl, Switzerland)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes