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Effects of Galvanic Vestibular Stimulation on posture and movement in patients with Parkinson's Disease: randomized clinical trial

Effects of Galvanic Vestibular Stimulation on motor control in patients with Parkinson's Disease: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-996f8qn
Enrollment
Unknown
Registered
2025-02-10
Start date
2024-11-26
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Interventions

This is a randomized, placebo-controlled, single-blind clinical study. The experimental group is made up of 30 participants with Parkinson's disease (H&Y: 2-3), who will receive the intervention with
E02.331.750

Sponsors

Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo
Lead Sponsor
Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo
Collaborator

Eligibility

Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients between 50 and 75 years of age; female or male; with a diagnosis of Parkinson's Disease - idiopathic PD in stages 2-3 of the modified Hoehn & Yahr Disability Scale (HY); undergoing regular monitoring at the Movement Disorder Outpatient Clinic; able to walk independently

Exclusion criteria

Exclusion criteria: Unable to remain independently in the standing position; severe visual impairment or not compensated with the use of corrective lenses; orthopedic disorders resulting in limitation of movement; using medication that acts on the vestibular system (e.g.: cinnarizine, flunarizine, betahistine, dimenhydrinate, meclizine and gingko biloba, among others); have Deep Brain Stimulation (DBS); history of seizures, pacemaker or metal implants in the head and neck region; undergoing neurofunctional physiotherapy and not accepting to suspend this treatment during the study period

Design outcomes

Primary

MeasureTime frame
An improvement in body balance measured by the Mini-Balance Evaluation Systems Test was expected in both groups, and was more evident, significantly, in the experimental group

Secondary

MeasureTime frame
Improvements in the partial measures of the Mini-Balance Evaluation Systems Test and Activity-specific Balance Confidence Scale are expected to be more significant in the experimental group;Improvements in the spatio-temporal gait parameters measured using an inertial sensor system are expected to be more significant in the experimental group;Improvements in the New Freezing of Gait Questionnaire are expected to be more significant in the experimental group;Improvements in the Timed Up and Go Test and Modified Parkinson Activity Scale are expected to be more significant in the experimental group;Improvements in the Nine Holes and Pins Test are expected to be more significant in the experimental group;Improvements in the Six-Minute Walk and Five Times Sit to Stand Tests are expected to be more significant in the experimental group;Improvements in the risk of falling (Mini-Balance Evaluation Systems Test, cut-off point 16/32) are expected to be more significant in the experimental group;Improvements in the Unified Parkinson's disease rating scale (UPDRS - part III - motor) are expected to be more significant in the experimental group;Improvements in the Parkinson's Disease Questionnaire-39 (PDQ-39) are expected to be more significant in the experimental group;Few notes are expected on the Safety and Satisfaction of the technique, carried out through the questionnaire for recording adverse events and satisfaction with the intervention of the participants at the end, prepared by the author for both groups

Countries

Brazil

Contacts

Public ContactCatarina Boffino

Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo

catarina.boffino@online.uscs.edu.br+55(11)45738000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)