Clinical trial NCT05047796: Effects of Osteopathic Visceral Manipulation on the Autonomic Nervous System, Balance and Gastrointestinal Disturbances in Individuals With Parkinson's Disease
Official title: Effects of Osteopathic Visceral Manipulation on the Autonomic Nervous System, Balance and Gastrointestinal Disturbances in Individuals With Parkinson's Disease: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson
Lead sponsor: Instituto Docusse de Osteopatia e Terapia Manual
Sponsor class: NETWORK
First posted: 2021-09-17
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Parkinson's disease (PD) is responsible for several changes in the body, such as balance, gastrointestinal and autonomic disorders and are associated with impairments in the clinical prognosis of these individuals. In this sense, therapies capable of minimizing this impact are extremely important. Osteopathy has become an alternative treatment for individuals with neurological disorders and has been shown to be effective in treating various conditions, including PD. Objective: a) to evaluate the acute effect of visceral manipulation directed to the intestines and visceral plexuses in the autonomic nervous system of PD patients; b) identify the effect of this approach, after four visits, on balance, plantar pressure, gastrointestinal disorders and autonomic nervous system in this population. Materials and Methods: For this randomized clinical trial, 28 adults diagnosed with PD will be recruited. Subjects will be randomized to protocols in two groups: intervention protocol and placebo protocol, where both will consist of 4 visits twice a week. The intervention protocol will consist of osteopathic manipulative techniques and the sham protocol will consist of simulation of therapy, where the therapist will place his hands in the same regions of the intervention protocol, with superficial contact and without therapeutic intention in each region. The outcome measures of the study will consist of Berg balance assessment and plantar pressure, Rome survey on gastrointestinal disorders, and assessment of autonomic modulation by means of heart rate variability analysis. Volunteers and evaluators will be blind to the protocol and not informed of their order. Only the person responsible for the intervention will not be blind to the protocol. Data will be analyzed according to normality (Shapiro-Wilk test), and comparisons of outcomes between the moments (pre and post) will be performed using the T-student test for paired data or Wilcoxon, as normal and for comparisons between protocols. placebo and intervention, Student's T-test for unpaired data or Mann-Whitney test according to normality will be applied. The adopted statistical significance will be fixed at 5%.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson's;
* Not having cardiorespiratory diseases;
* Not being a smoker;
* Do not use alcoholic beverages;
* No cognitive deficit;
* No osteoarticular deformities, plantar ulcers, total or partial amputation of the feet;
* They do not need auxiliary devices for walking

Exclusion Criteria:

* Data from individuals with a series of heart rate intervals with less than 95% of sinus beats will be excluded from the study.

Primary outcomes:
measure: Change in heart rate variability
timeFrame: T0= before the protocol (15 minutes); T1= until 48 hours after the end protocol (15 minutes)
Secondary outcomes:
measure: Change in balance
timeFrame: T0= before the protocol; T1= until 48 hours after the end protocol
measure: Change in plantar pressure
timeFrame: T0= before the protocol; T1= until 48 hours after the end protocol
Other outcomes:
Locations:
city: Presidente Prudente
country: Brazil
facility: Anne Kastelianne
state: São Paulo
Study officials:
References: