Effects of Osteopathic Visceral Manipulation on the Autonomic Nervous System, Balance and Gastrointestinal Disturbances in Individuals With Parkinson's Disease

NCT05047796 | Completed

• 1 other identifier: 18945219.4.0000.5402
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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%.

Conditions

Parkinson Disease

Keywords

Parkinson

Outcome Measures

Primary Outcomes (1)

• Change in heart rate variability

  For the analysis, frequency domain indices (LF, HF, LF/HF), time domain (SDNN, RMSSD) and geometric indices will be used

  T0= before the protocol (15 minutes); T1= until 48 hours after the end protocol (15 minutes)

Secondary Outcomes (2)

• Change in balance

  T0= before the protocol; T1= until 48 hours after the end protocol

• Change in plantar pressure

  T0= before the protocol; T1= until 48 hours after the end protocol

Study Arms (2)

Intervention Protocol

EXPERIMENTAL

Visceral osteopathic techniques

Other: Intervention Protocol

Sham Protocol

SHAM COMPARATOR

Simulated visceral osteopathic techniques

Other: Sham Protocol

Interventions

Intervention Protocol OTHER

The intervention protocol will consist of visceral osteopathic techniques and will be performed by a professional who has 17 years of clinical experience in the field of Osteopathy.

Intervention Protocol

Sham Protocol OTHER

The sham protocol will be performed by a professional who has 17 years of clinical experience in the field of Osteopathy. The sham protocol will consist of simulation of therapy, where the therapist will place his hands in the same regions of the intervention protocol, without therapeutic intent

Sham Protocol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Docusse de Osteopatia e Terapia Manual: lead

Study Sites (1)

Anne Kastelianne

Presidente Prudente, São Paulo, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Each participant will be randomly assigned to the intervention group or placebo group by an independent study evaluator. Data will be secretly allocated through sealed, opaque envelopes. After the randomization process, the participant will be evaluated by a researcher who will not have knowledge about the distribution of the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 17, 2021
• Study Start: September 15, 2021
• Primary Completion: October 5, 2021
• Study Completion: October 30, 2021
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After one year of publication
• Access Criteria: To receive the data, the researcher must have sent a request to nupi@idot.com.br

Locations

BR (1)