Parkinson DiseaseNCT04941326
The Effect of Spinal Mobilization on Respiratory Parameters in Parkinson's Disease Patients
A study testing Diaphragmatic stimulation treatment with PNF techniques, Costal mobilization and Breathing exercises in people with Parkinson Disease and Camptocormia, run by Abant Izzet Baysal University at 2 sites in Turkey (Türkiye).
Trial summary
Parkinson's patients suffer from respiratory distress for different reasons. It is thought that physiotherapy methods that have an indirect effect on the diaphragm can improve respiratory functions. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson Disease, Camptocormia, Restrictive Lung Disease
- What is being tested?
- Diaphragmatic stimulation treatment with PNF techniques, Costal mobilization and Breathing exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Aug 2021to 1 Dec 2025
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with Parkinson's disease
- Volunteering to participate in the study
- Modified Medical Research Council (MMRC) score >2
Who cannot join
- Those with COVID-19
- Diseases that increase intra-abdominal pressure
- Diseases affecting diaphragmatic motility
- Those who had a recent thoracic or abdominal operation
- Those who have a parenchymal, pleural or chest wall mass that will cause restriction on a recent chest X-ray or CT will not be included in the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Abant Izzet Baysal University Faculty of Health Science
Bolu, 14100
Ramazan Kurul, Ph.D, +905436414731, ramazankurul2@hotmail.com
Enes Tayyip Benli, MSc, +905387359268, enestayyipbenli@gmail.com
- Recruiting
AIBU Physical Therapy and Rehabiltiation Department
Bolu
Ramazan Kurul, Ph.D
About this study
Official title: Investigation of the Effect of Spinal Mobilization and Respiration Techniques on Posture and Respiratory Function in Parkinson's Patients
Parkinson's patients suffer from respiratory distress for different reasons. It is thought that physiotherapy methods that have an indirect effect on the diaphragm can improve respiratory functions. The aim of this study is to investigate the effects of spinal mobilization and diaphragmatic breathing techniques on respiratory function.
Read the detailed description
Respiratory complications are one of the most common causes of death in Parkinson's patients. Camptocormia may develop in Parkinson's disease and other pathological conditions involving the basal ganglia, which can be defined as an abnormal flexion of the thoracolumbar spine of 45° or more, which increases during walking or standing and disappears completely in the supine position. Parkinson's patients with camptocormia often complain of dyspnea, which can be attributed to reduced lung capacity due to limited chest expansion.
Restrictive changes due to respiratory muscle dysfunction in Parkinson's disease, upper airway obstruction, abnormal ventilatory control, and drug use such as levodopa have an effect on respiratory functions.
Restrictive dysfunction has been reported in 28-94% of patients with Parkinson's.
Postural disorders such as camptocormia can also lead to restriction. One study found that the lung volumes of Parkinson's disease patients with camptocormia decreased, although it was not associated with major clinical changes.
Diaphragmatic dyskinesia in Parkinson's patients may also lead to a restrictive deterioration in respiratory functions.
Studies examining the effects of chest and diaphragm mobilization on spirometric parameters in patients with cerebral palsy reported that the applied mobilization and soft tissue techniques improved FEV1 and FVC. The effect of indirect diaphragmatic treatments with vertebral mobilization in individuals with Parkinson's who are at risk of experiencing restrictive respiratory problems is unknown. The aim of this study is to examine the effects of spinal mobilization techniques for the diaphragm on respiratory function parameters and posture.
- Conditions
- Parkinson Disease, Camptocormia, Restrictive Lung Disease
- Being tested
- Diaphragmatic stimulation treatment with PNF techniques, Costal mobilization, Breathing exercises, Spinal mobilization, Sham mobilization
- Keywords
- Rehabilitation, Posture
- Medical subject headings
- Parkinson Disease, Camptocormia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic stimulation treatment with PNF techniquesOther
Thumbs and palms are placed along the cartilage edges of the lower ribs. At the end of the expiration, pressure and stretching are given as far into the chest and upwards as possible and a deep inspiration is requested immediately after the pressure. Both sides can be stimulated by repeated contraction technique. Hand holding positions may differ according to the patient's preference. If the patient's physical condition is not suitable, the application can be done with the thumbs, the thumb of the left hand for the right rib, and the thumb of the right hand for the left rib in the same lying position. The patient will be asked to do the application 2 times in a day with 10 repetitions for 4 weeks.
Costal mobilizationOther
In the supine position, the individual will place both hands around the 10-12th ribs and alternately apply an oblique push from the right and left sides to the opposite side. The exercise will be taught to the patient as training, and he will be asked to apply it 2 times a day with 20 repetitions for 4 weeks.
Breathing exercisesOther
It is done to increase the diaphragm activity of the individual and to suppress chest breathing. While lying in the supine position, the legs are placed in a hooked position, with one hand on the abdomen and the other on the chest, and the deep breath that is taken from the nose in 2 seconds is asked to exhale through the mouth in 4 seconds, while revealing as little movement in the chest as possible, the main movement is requested to be around the abdomen. The application will be given to the patient as a home program and he will be asked to do it 2 times a day with 5 repetitions for 4 weeks.
Spinal mobilizationOther
T12 vertebrae will be found by following the 12th rib in the prone position of the individual and spinous of L1 and L2 vertebrae will be determined with this reference. Then, small amplitude rotational movements in the vertebrae will be revealed by pushing in the anterior direction over the transverse processes. This application will be applied once a week for an average of 10 minutes for 4 weeks.
Sham mobilizationOther
Sham pressures will be applied to the lumbar region of the patient, away from the vertebrae. This application will be applied once a week for an average of 10 minutes for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Spinal mobilization group | Active comparator | Spinal mobilization will be applied to the application group for 4 weeks in addition to the treatments applied to the sham group Receives: Other: Diaphragmatic stimulation treatment with PNF techniques; Other: Costal mobilization; Other: Breathing exercises; Other: Spinal mobilization |
| Sham group | Sham comparator | Diaphragmatic stimulation with proprioceptive neuromuscular facilitation techniques (PNF), diaphragmatic breathing techniques, costal mobilization treatments and sham mobilization will be applied to the sham group. Receives: Other: Diaphragmatic stimulation treatment with PNF techniques; Other: Costal mobilization; Other: Breathing exercises; Other: Sham mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function Test
Respiratory function tests will be performed on all individuals with the MIR SPIROLAB II brand pulmonary function test device. In each measurement, the maneuvers will be repeated at least 3 times and the best values will be recorded. Forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) results from the test will be used to calculate the ratio of FEV1 to FVC (FEV1/FVC) will be recorded. The combined FEV1/FVC ratio will be used as primary outcome.
Measured: Four weeks
Secondary outcomes (3)
Spinal Mouse Evaluation
The Spinal Mouse is a computer-aided, non-invasive, easy-to-use electromagnetic handheld device designed to measure the curvature of the spine in various positions. Validity-reliability studies of the Spinal Mouse were conducted. Spinal posture assessment will be performed in the sagittal position. All spinous processes will be detected by palpation, starting from the spinous process of the seventh cervical vertebra to the spinous process of the third sacral vertebra by the physiotherapist. Measurements are planned to be performed in two different positions;
- the individual is in a standing upright position.
- the individual is asked to perform maximum body flexion
Measured: Four weeks
Camptocormia and Range of Motion Evaluations
Postural deviations of the spine will be recorded through photographs taken from the side and back in the standing position. Flexion of the individual more than 45° from the thoracolumbar spine will be recorded as the presence of camptocormia.
- Evaluation of the spine from a lateral view; The baseline is drawn perpendicular to the ground and passing behind the 5th lumbar spine. The body line is drawn to pass through the 1st thoracic vertebra and the 5th lumbar vertebra. The angle between the two lines is measured.
The flexion angle and extension angle deficit of the knee joint will be measured with a goniometer.
Measured: Four weeks
Ultrasonography
When the patient is in the supine position, by placing a transducer on the chest wall at the level of the right 9th intercostal space, diaphragmatic movement will be monitored during inspiration, and diaphragmatic thickness will be measured at the end of expiration and inspiration.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start15 Aug 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
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.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Model description
- Two groups with sham control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan KURUL, Abant Izzet Baysal University
- Investigators
- Ramazan Kurul, Ph.D, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941326
- Sponsor's protocol ID
- AIBU-FTR-ETB-001
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2021
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Spinal Mobilization and Respiration Techniques on Posture and Respiratory Function in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT04941326
- Acronym / sponsor ID
- AIBU-FTR-ETB-001
- Conditions
- Parkinson Disease, Camptocormia, Restrictive Lung Disease
- Keywords
- Rehabilitation, Posture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 28 Jun 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.
Parkinson's patients suffer from respiratory distress for different reasons. It is thought that physiotherapy methods that have an indirect effect on the diaphragm can improve respiratory functions. The aim of this study is to investigate the effects of spinal mobilization and diaphragmatic breathing techniques on respiratory function.
Detailed description
Respiratory complications are one of the most common causes of death in Parkinson's patients. Camptocormia may develop in Parkinson's disease and other pathological conditions involving the basal ganglia, which can be defined as an abnormal flexion of the thoracolumbar spine of 45° or more, which increases during walking or standing and disappears completely in the supine position. Parkinson's patients with camptocormia often complain of dyspnea, which can be attributed to reduced lung capacity due to limited chest expansion.
Restrictive changes due to respiratory muscle dysfunction in Parkinson's disease, upper airway obstruction, abnormal ventilatory control, and drug use such as levodopa have an effect on respiratory functions.
Restrictive dysfunction has been reported in 28-94% of patients with Parkinson's.
Postural disorders such as camptocormia can also lead to restriction. One study found that the lung volumes of Parkinson's disease patients with camptocormia decreased, although it was not associated with major clinical changes.
Diaphragmatic dyskinesia in Parkinson's patients may also lead to a restrictive deterioration in respiratory functions.
Studies examining the effects of chest and diaphragm mobilization on spirometric parameters in patients with cerebral palsy reported that the applied mobilization and soft tissue techniques improved FEV1 and FVC. The effect of indirect diaphragmatic treatments with vertebral mobilization in individuals with Parkinson's who are at risk of experiencing restrictive respiratory problems is unknown. The aim of this study is to examine the effects of spinal mobilization techniques for the diaphragm on respiratory function parameters and posture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with sham control group
| Arm | Type | Receives |
|---|---|---|
| Spinal mobilization group | Active comparator | Other: Diaphragmatic stimulation treatment with PNF techniques, Other: Costal mobilization, Other: Breathing exercises, Other: Spinal mobilizationSpinal mobilization will be applied to the application group for 4 weeks in addition to the treatments applied to the sham group |
| Sham group | Sham comparator | Other: Diaphragmatic stimulation treatment with PNF techniques, Other: Costal mobilization, Other: Breathing exercises, Other: Sham mobilizationDiaphragmatic stimulation with proprioceptive neuromuscular facilitation techniques (PNF), diaphragmatic breathing techniques, costal mobilization treatments and sham mobilization will be applied to the sham group. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have been diagnosed with Parkinson's disease
- Volunteering to participate in the study
- Modified Medical Research Council (MMRC) score >2
Key exclusion criteria (5 listed)
- Those with COVID-19
- Diseases that increase intra-abdominal pressure
- Diseases affecting diaphragmatic motility
- Those who had a recent thoracic or abdominal operation
- Those who have a parenchymal, pleural or chest wall mass that will cause restriction on a recent chest X-ray or CT will not be included in 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 |
|---|---|---|
| Diaphragmatic stimulation treatment with PNF techniquesThumbs and palms are placed along the cartilage edges of the lower ribs. At the end of the expiration, pressure and stretching are given as far into the chest and upwards as possible and a deep inspiration is requested immediately after the pressure. Both sides can be stimulated by repeated contraction technique. Hand holding positions may differ according to the patient's preference. If the patient's physical condition is not suitable, the application can be done with the thumbs, the thumb of the left hand for the right rib, and the thumb of the right hand for the left rib in the same lying position. The patient will be asked to do the application 2 times in a day with 10 repetitions for 4 weeks. | Other | Sham group, Spinal mobilization group |
| Costal mobilizationIn the supine position, the individual will place both hands around the 10-12th ribs and alternately apply an oblique push from the right and left sides to the opposite side. The exercise will be taught to the patient as training, and he will be asked to apply it 2 times a day with 20 repetitions for 4 weeks. | Other | Sham group, Spinal mobilization group |
| Breathing exercisesIt is done to increase the diaphragm activity of the individual and to suppress chest breathing. While lying in the supine position, the legs are placed in a hooked position, with one hand on the abdomen and the other on the chest, and the deep breath that is taken from the nose in 2 seconds is asked to exhale through the mouth in 4 seconds, while revealing as little movement in the chest as possible, the main movement is requested to be around the abdomen. The application will be given to the patient as a home program and he will be asked to do it 2 times a day with 5 repetitions for 4 weeks. | Other | Sham group, Spinal mobilization group |
| Spinal mobilizationT12 vertebrae will be found by following the 12th rib in the prone position of the individual and spinous of L1 and L2 vertebrae will be determined with this reference. Then, small amplitude rotational movements in the vertebrae will be revealed by pushing in the anterior direction over the transverse processes. This application will be applied once a week for an average of 10 minutes for 4 weeks. | Other | Spinal mobilization group |
| Sham mobilizationSham pressures will be applied to the lumbar region of the patient, away from the vertebrae. This application will be applied once a week for an average of 10 minutes for 4 weeks. | Other | Sham group |
Primary outcome
Pulmonary Function Test
Time frame: Four weeks
Respiratory function tests will be performed on all individuals with the MIR SPIROLAB II brand pulmonary function test device. In each measurement, the maneuvers will be repeated at least 3 times and the best values will be recorded. Forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) results from the test will be used to calculate the ratio of FEV1 to FVC (FEV1/FVC) will be recorded. The combined FEV1/FVC ratio will be used as primary outcome.
3 secondary outcomes
Spinal Mouse Evaluation
Time frame: Four weeks
Camptocormia and Range of Motion Evaluations
Time frame: Four weeks
Ultrasonography
Time frame: Four weeks
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 22 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Ramazan Kurul, Ph.D principal investigator
Abant Izzet Baysal University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic stimulation treatment with PNF techniques, Costal mobilization and Breathing exercises in people with Parkinson Disease and Camptocormia, run by Abant Izzet Baysal University at 2 sites in Turkey (Türkiye).
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 3 inclusion and 5 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 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
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 Ramazan Kurul, Ph.D (+905436414731, ramazankurul2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Test (time frame: Four weeks). 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 22 Jun 2025.