Parkinson DiseaseNCT06955377
Effect of Trunk Flexion on Airway Defense in Parkinson's Disease
An observational study of Parkinson Disease, run by General University Hospital, Prague at 1 site in Czechia.
Trial summary
The main mechanisms of airway protection include a properly functioning swallowing process and a cough. Studies focusing on patients with Parkinson's disease (PD) have previously demonstrated impairments in both swallowing (dysphagia) and coughing (dystussia). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 18 Feb 2025to Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For this study, participants will be selected from patients with Parkinson's Disease who are being monitored at the Extrapyramidal Center of the Neurology Clinic and the Center for Clinical Neuroscience at the First Faculty of Medicine, Charles University, and the General University Hospital in Prague.
Who may be able to join
- Diagnosis of Parkinson' s disease
- Age ≥ 18 years
Who cannot join
- Unreliable performance of MIP, MEP, or grip strength measurements, for example, due to cognitive deficits (assessed by the researcher)
- Inadequate lip seal
- Significant deformities of the dominant hand that could affect the accuracy of grip strength measurements
- Other severe neurological diseases apart from PD
- History of unstable cardiovascular disease
- Severe pulmonary disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martin Srp, PhD. contact
Czechia1 site, 1 recruiting
- Recruiting
General University Hospital
Prague, 12000
Kateřina Dvořáková, MSc., +420 224 965 513, katerina.dvorakova@vfn.cz
About this study
Official title: Effect of Forward Trunk Flexion in Patients With Parkinson's Disease on the Airway Defense System
The main mechanisms of airway protection include a properly functioning swallowing process and a cough. Studies focusing on patients with Parkinson's disease (PD) have previously demonstrated impairments in both swallowing (dysphagia) and coughing (dystussia). Aspiration pneumonia is the leading cause of death in individuals with PD.
Swallowing function is directly related to body posture. Postural abnormalities (PA) are a common symptom of PD and significantly contribute to patient disability, affect respiratory function, and reduce quality of life. Previous research has shown that more than 20% of PD patients suffer from some form of PA.
Read more
Most PD patients with a forward trunk flexion angle greater than 30 degrees report specific difficulties, such as dysphagia. A link has previously been demonstrated between postural abnormalities associated with flexed posture and restrictive ventilatory impairment. It can be assumed that this restrictive ventilatory impairment, which reduces the amount of air the patient can inhale into the lungs and subsequently exhale, negatively affects the strength of voluntary cough. However, this hypothesis has not yet been verified in the mentioned patient group.
The primary aim of the study will be to examine the effect of forward trunk flexion (FTF) in Parkinson's disease on the airway defense system.
Read the detailed description
The primary aim of the study will be to verify the potential relationship between forward trunk flexion, respiratory muscle strength, and the strength of voluntary cough.
Hypotheses:
- Forward trunk flexion in patients with Parkinson's disease (PD) will negatively affect respiratory muscle strength and the strength of voluntary cough.
- Respiratory muscle strength and the strength of voluntary cough will deteriorate more rapidly over a three-year period in patients with PD and forward trunk flexion than in patients with PD without forward trunk flexion.
The secondary aim will be to correlate respiratory muscle strength and the strength of voluntary cough with handgrip strength and the pulmonary dysfunction index as potential screening methods.
Hypothesis:
- Handgrip strength and the pulmonary dysfunction index will correlate with respiratory muscle strength and the strength of voluntary cough.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Postural abnormalities, Airway defense system
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson's disease | Participants of both groups will attend a total of five visits. During each visit, the participants will undergo a complete assessment including respiratory muscle strength, cough strength, dynamic spirometry, grip strength via a digital hand dynamometer, and evaluation of pulmonary dysfunction using the Index of Pulmonary Dysfunction (IPD) questionnaire. Each examination will last approximately 20 minutes, with no specific training or additional procedures required between visits. | |
| Patients with Parkinson's disease and forward trunk flexion | Patients with pathological forward trunk flexion defined as thoracic (≥25°) or lumbar flexion (>15°) in standing and walking, which completely disappears in the supine position. Participants of both groups will attend a total of five visits. During each visit, the participants will undergo a complete assessment including respiratory muscle strength, cough strength, dynamic spirometry, grip strength via a digital hand dynamometer, and evaluation of pulmonary dysfunction using the Index of Pulmonary Dysfunction (IPD) questionnaire. Each examination will last approximately 20 minutes, with no specific training or additional procedures required between visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voluntary peak cough flow
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Measured: baseline, 12months, 24months, 36months
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Measured: baseline, 12months, 24months, 36months
Forced vital capacity (FVC)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Measured: baseline, 12months, 24months, 36months
Forced expiratory volume (FEV1)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Measured: baseline, 12months, 24months, 36months
Peak expiratory flow (PEF)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Measured: baseline, 12months, 24months, 36months
Secondary outcomes (2)
Hand grip strength
The assessment of hand grip strength will be conducted according to the recommendations of the American Society of Hand Therapists. A digital hand dynamometer will be used.
Measured: baseline, 12months, 24months, 36months
Index of Pulmonary Dysfunction (IPD)
The screening assessment using the IPD questionnaire will involve the evaluation of four clinical indicators. The first two are direct questions asked to the patient regarding mucus management and cough strength. The third item is the strength of the voluntarily induced cough, subjectively assessed by the examiner. The fourth item tests the patient's ability to count out loud for as long as possible after a maximum inspiratory effort.
Measured: baseline, 12months, 24months, 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start18 Feb 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kateřina Dvořáková, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955377
- Sponsor's protocol ID
- 16/25 S-IV
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Forsyth AL, Joshi RY, Canning CG, Allen NE, Paul SS. Flexed Posture in Parkinson Disease: Associations With Nonmotor Impairments and Activity Limitations. Phys Ther. 2019 Jul 1;99(7):893-903. doi: 10.1093/ptj/pzz033.
PubMed 30830153Margraf NG, Granert O, Hampel J, Wrede A, Schulz-Schaeffer WJ, Deuschl G. Clinical Definition of Camptocormia in Parkinson's Disease. Mov Disord Clin Pract. 2016 Oct 11;4(3):349-357. doi: 10.1002/mdc3.12437. eCollection 2017 May-Jun.
PubMed 30363363Tinazzi M, Gandolfi M, Ceravolo R, Capecci M, Andrenelli E, Ceravolo MG, Bonanni L, Onofrj M, Vitale M, Catalan M, Polverino P, Bertolotti C, Mazzucchi S, Giannoni S, Smania N, Tamburin S, Vacca L, Stocchi F, Radicati FG, Artusi CA, Zibetti M, Lopiano L, Fasano A, Geroin C. Postural Abnormalities in Parkinson's Disease: An Epidemiological and Clinical Multicenter Study. Mov Disord Clin Pract. 2019 Jun 29;6(7):576-585. doi: 10.1002/mdc3.12810. eCollection 2019 Sep.
PubMed 31538092Claus I, Muhle P, Czechowski J, Ahring S, Labeit B, Suntrup-Krueger S, Wiendl H, Dziewas R, Warnecke T. Expiratory Muscle Strength Training for Therapy of Pharyngeal Dysphagia in Parkinson's Disease. Mov Disord. 2021 Aug;36(8):1815-1824. doi: 10.1002/mds.28552. Epub 2021 Mar 2.
PubMed 33650729Troche MS, Curtis JA, Sevitz JS, Dakin AE, Perry SE, Borders JC, Grande AA, Mou Y, Vanegas-Arroyave N, Hegland KW. Rehabilitating Cough Dysfunction in Parkinson's Disease: A Randomized Controlled Trial. Mov Disord. 2023 Feb;38(2):201-211. doi: 10.1002/mds.29268. Epub 2022 Nov 7.
PubMed 36345090
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Forward Trunk Flexion in Patients With Parkinson's Disease on the Airway Defense System
- ClinicalTrials.gov ID
- NCT06955377
- Acronym / sponsor ID
- 16/25 S-IV
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Postural abnormalities, Airway defense system
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 2 May 2025 (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.
The main mechanisms of airway protection include a properly functioning swallowing process and a cough. Studies focusing on patients with Parkinson's disease (PD) have previously demonstrated impairments in both swallowing (dysphagia) and coughing (dystussia). Aspiration pneumonia is the leading cause of death in individuals with PD.
Swallowing function is directly related to body posture. Postural abnormalities (PA) are a common symptom of PD and significantly contribute to patient disability, affect respiratory function, and reduce quality of life. Previous research has shown that more than 20% of PD patients suffer from some form of PA.
Most PD patients with a forward trunk flexion angle greater than 30 degrees report specific difficulties, such as dysphagia. A link has previously been demonstrated between postural abnormalities associated with flexed posture and restrictive ventilatory impairment. It can be assumed that this restrictive ventilatory impairment, which reduces the amount of air the patient can inhale into the lungs and subsequently exhale, negatively affects the strength of voluntary cough. However, this hypothesis has not yet been verified in the mentioned patient group.
The primary aim of the study will be to examine the effect of forward trunk flexion (FTF) in Parkinson's disease on the airway defense system.
Detailed description
The primary aim of the study will be to verify the potential relationship between forward trunk flexion, respiratory muscle strength, and the strength of voluntary cough.
Hypotheses:
- Forward trunk flexion in patients with Parkinson's disease (PD) will negatively affect respiratory muscle strength and the strength of voluntary cough.
- Respiratory muscle strength and the strength of voluntary cough will deteriorate more rapidly over a three-year period in patients with PD and forward trunk flexion than in patients with PD without forward trunk flexion.
The secondary aim will be to correlate respiratory muscle strength and the strength of voluntary cough with handgrip strength and the pulmonary dysfunction index as potential screening methods.
Hypothesis:
- Handgrip strength and the pulmonary dysfunction index will correlate with respiratory muscle strength and the strength of voluntary cough.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson's disease | – | –Participants of both groups will attend a total of five visits. During each visit, the participants will undergo a complete assessment including respiratory muscle strength, cough strength, dynamic spirometry, grip strength via a digital hand dynamometer, and evaluation of pulmonary dysfunction using the Index of Pulmonary Dysfunction (IPD) questionnaire. Each examination will last approximately 20 minutes, with no specific training or additional procedures required between visits. |
| Patients with Parkinson's disease and forward trunk flexion | – | –Patients with pathological forward trunk flexion defined as thoracic (≥25°) or lumbar flexion (>15°) in standing and walking, which completely disappears in the supine position. Participants of both groups will attend a total of five visits. During each visit, the participants will undergo a complete assessment including respiratory muscle strength, cough strength, dynamic spirometry, grip strength via a digital hand dynamometer, and evaluation of pulmonary dysfunction using the Index of Pulmonary Dysfunction (IPD) questionnaire. Each examination will last approximately 20 minutes, with no specific training or additional procedures required between visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For this study, participants will be selected from patients with Parkinson's Disease who are being monitored at the Extrapyramidal Center of the Neurology Clinic and the Center for Clinical Neuroscience at the First Faculty of Medicine, Charles University, and the General University Hospital in Prague.
Key inclusion criteria (2 listed)
- Diagnosis of Parkinson' s disease
- Age ≥ 18 years
Key exclusion criteria (6 listed)
- Unreliable performance of MIP, MEP, or grip strength measurements, for example, due to cognitive deficits (assessed by the researcher)
- Inadequate lip seal
- Significant deformities of the dominant hand that could affect the accuracy of grip strength measurements
- Other severe neurological diseases apart from PD
- History of unstable cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Voluntary peak cough flow
Time frame: baseline, 12months, 24months, 36months
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)
Time frame: baseline, 12months, 24months, 36months
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Forced vital capacity (FVC)
Time frame: baseline, 12months, 24months, 36months
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Forced expiratory volume (FEV1)
Time frame: baseline, 12months, 24months, 36months
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Peak expiratory flow (PEF)
Time frame: baseline, 12months, 24months, 36months
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
2 secondary outcomes
Hand grip strength
Time frame: baseline, 12months, 24months, 36months
Index of Pulmonary Dysfunction (IPD)
Time frame: baseline, 12months, 24months, 36months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Background: PubMed 30830153Forsyth AL, Joshi RY, Canning CG, Allen NE, Paul SS. Flexed Posture in Parkinson Disease: Associations With Nonmotor Impairments and Activity Limitations. Phys Ther. 2019 Jul 1;99(7):893-903. doi: 10.1093/ptj/pzz033.
- Background: PubMed 30363363Margraf NG, Granert O, Hampel J, Wrede A, Schulz-Schaeffer WJ, Deuschl G. Clinical Definition of Camptocormia in Parkinson's Disease. Mov Disord Clin Pract. 2016 Oct 11;4(3):349-357. doi: 10.1002/mdc3.12437. eCollection 2017 May-Jun.
- Background: PubMed 31538092Tinazzi M, Gandolfi M, Ceravolo R, Capecci M, Andrenelli E, Ceravolo MG, Bonanni L, Onofrj M, Vitale M, Catalan M, Polverino P, Bertolotti C, Mazzucchi S, Giannoni S, Smania N, Tamburin S, Vacca L, Stocchi F, Radicati FG, Artusi CA, Zibetti M, Lopiano L, Fasano A, Geroin C. Postural Abnormalities in Parkinson's Disease: An Epidemiological and Clinical Multicenter Study. Mov Disord Clin Pract. 2019 Jun 29;6(7):576-585. doi: 10.1002/mdc3.12810. eCollection 2019 Sep.
- Background: PubMed 33650729Claus I, Muhle P, Czechowski J, Ahring S, Labeit B, Suntrup-Krueger S, Wiendl H, Dziewas R, Warnecke T. Expiratory Muscle Strength Training for Therapy of Pharyngeal Dysphagia in Parkinson's Disease. Mov Disord. 2021 Aug;36(8):1815-1824. doi: 10.1002/mds.28552. Epub 2021 Mar 2.
- Background: PubMed 36345090Troche MS, Curtis JA, Sevitz JS, Dakin AE, Perry SE, Borders JC, Grande AA, Mou Y, Vanegas-Arroyave N, Hegland KW. Rehabilitating Cough Dysfunction in Parkinson's Disease: A Randomized Controlled Trial. Mov Disord. 2023 Feb;38(2):201-211. doi: 10.1002/mds.29268. Epub 2022 Nov 7.
- Individual participant dataSharing planned: Undecided
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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.
Martin Srp, PhD. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by General University Hospital, Prague at 1 site in Czechia.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 May 2025. 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 Czechia. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kateřina Dvořáková, MSc. (+420 224 965 513, katerina.dvorakova@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voluntary peak cough flow (time frame: baseline, 12months, 24months, 36months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06955377, which also lists 5 linked publications.
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 2 May 2025.