Parkinson DiseaseNCT05047796
Effects of Osteopathic Visceral Manipulation on the Autonomic Nervous System, Balance and Gastrointestinal Disturbances in Individuals With Parkinson's Disease
A study testing Intervention Protocol in people with Parkinson Disease, run by Instituto Docusse de Osteopatia e Terapia Manual at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Intervention Protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Sep 2021to 30 Oct 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Data from individuals with a series of heart rate intervals with less than 95% of sinus beats will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Intervention Protocol, Sham Protocol
- Keywords
- Parkinson
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ProtocolOther
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.
Sham ProtocolOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Protocol | Experimental | Visceral osteopathic techniques Receives: Other: Intervention Protocol |
| Sham Protocol | Sham comparator | Simulated visceral osteopathic techniques Receives: Other: Sham Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: T0= before the protocol (15 minutes); T1= until 48 hours after the end protocol (15 minutes)
Secondary outcomes (2)
Change in balance
For balance analysis we will use the Berg balance scale, validated for the Brazilian population. The overall score is 56 points. A score from 0 to 20 represents impairment of balance, 21 to 40 is acceptable balance, and 41-56 is good balance.
Measured: T0= before the protocol; T1= until 48 hours after the end protocol
Change in plantar pressure
The static plantar pressure profile will be obtained through pressure sensors present in the platform
Measured: T0= before the protocol; T1= until 48 hours after the end protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start15 Sep 2021
- Primary completion5 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Docusse de Osteopatia e Terapia Manual
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047796
- Sponsor's protocol ID
- 18945219.4.0000.5402
- Status last verified
- Mar 2024
- First submitted
- 3 Sep 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared for any researcher that requests the data by electronic address
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05047796
- Acronym / sponsor ID
- 18945219.4.0000.5402
- Conditions
- Parkinson Disease
- Keywords
- Parkinson
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Instituto Docusse de Osteopatia e Terapia ManualResearch network
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 17 Sep 2021 (actual)
- 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.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Protocol | Experimental | Other: Intervention ProtocolVisceral osteopathic techniques |
| Sham Protocol | Sham comparator | Other: Sham ProtocolSimulated visceral osteopathic techniques |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of Parkinson's;
- Not having cardiorespiratory diseases;
- Not being a smoker;
- Do not use alcoholic beverages;
- No cognitive deficit;
Key exclusion criteria (1 listed)
- Data from individuals with a series of heart rate intervals with less than 95% of sinus beats will be excluded from the study.
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 |
|---|---|---|
| Intervention ProtocolThe 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. | Other | Intervention Protocol |
| Sham ProtocolThe 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 | Other | Sham Protocol |
Primary outcome
Change in heart rate variability
Time frame: T0= before the protocol (15 minutes); T1= until 48 hours after the end protocol (15 minutes)
For the analysis, frequency domain indices (LF, HF, LF/HF), time domain (SDNN, RMSSD) and geometric indices will be used
2 secondary outcomes
Change in balance
Time frame: T0= before the protocol; T1= until 48 hours after the end protocol
Change in plantar pressure
Time frame: T0= before the protocol; T1= until 48 hours after the end protocol
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 13 Mar 2024.
- Individual participant dataSharing planned: Yes. The data will be shared for any researcher that requests the data by electronic address
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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 Intervention Protocol in people with Parkinson Disease, run by Instituto Docusse de Osteopatia e Terapia Manual 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 7 inclusion and 1 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 13 Mar 2024. 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?
Change in heart rate variability (time frame: T0= before the protocol (15 minutes); T1= until 48 hours after the end protocol (15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.