The Effect of Spinal Mobilization on Respiratory Parameters in Parkinson's Disease Patients

NCT ID: NCT04941326

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-15

Study Completion Date

2025-12-01

Brief Summary

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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

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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

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Parkinson Disease Camptocormia Restrictive Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups with sham control group
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participans and outcome assessors will be blinded to group allocation. Control group will receive same amount of sham mobilisations.

Study Groups

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Spinal mobilization group

Spinal mobilization will be applied to the application group for 4 weeks in addition to the treatments applied to the sham group

Group Type ACTIVE_COMPARATOR

Diaphragmatic stimulation treatment with PNF techniques

Intervention Type OTHER

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 mobilization

Intervention Type OTHER

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 exercises

Intervention Type OTHER

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 mobilization

Intervention Type OTHER

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 group

Diaphragmatic stimulation with proprioceptive neuromuscular facilitation techniques (PNF), diaphragmatic breathing techniques, costal mobilization treatments and sham mobilization will be applied to the sham group.

Group Type SHAM_COMPARATOR

Diaphragmatic stimulation treatment with PNF techniques

Intervention Type OTHER

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 mobilization

Intervention Type OTHER

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 exercises

Intervention Type OTHER

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.

Sham mobilization

Intervention Type OTHER

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.

Interventions

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Diaphragmatic stimulation treatment with PNF techniques

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.

Intervention Type OTHER

Costal mobilization

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.

Intervention Type OTHER

Breathing exercises

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.

Intervention Type OTHER

Spinal mobilization

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.

Intervention Type OTHER

Sham mobilization

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Have been diagnosed with Parkinson's disease
* Volunteering to participate in the study
* Modified Medical Research Council (MMRC) score \>2

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Ramazan KURUL

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramazan Kurul, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Abant Izzet Baysal University

Locations

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Abant Izzet Baysal University Faculty of Health Science

Bolu, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

AIBU Physical Therapy and Rehabiltiation Department

Bolu, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ramazan Kurul, Ph.D

Role: CONTACT

+905436414731

Enes Tayyip Benli, MSc

Role: CONTACT

+905387359268

Facility Contacts

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Ramazan Kurul, Ph.D

Role: primary

+905436414731

Enes Tayyip Benli, MSc

Role: backup

+905387359268

Ramazan Kurul, Ph.D

Role: primary

Other Identifiers

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AIBU-FTR-ETB-001

Identifier Type: -

Identifier Source: org_study_id

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