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

Primary Purpose

Parkinson Disease, Camptocormia, Restrictive Lung Disease

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Diaphragmatic stimulation treatment with PNF techniques
Costal mobilization
Breathing exercises
Spinal mobilization
Sham mobilization
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Rehabilitation, Posture

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have been diagnosed with Parkinson's disease
  • Volunteering to participate in the study

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

Sites / Locations

  • Abant Izzet Baysal University Faculty of Health Science
  • AIBU Physical Therapy and Rehabiltiation DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Spinal mobilization group

Sham group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
June 15, 2021
Last Updated
December 23, 2022
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT04941326
Brief Title
The Effect of Spinal Mobilization on Respiratory Parameters in Parkinson's Disease Patients
Official Title
Investigation of the Effect of Spinal Mobilization and Respiration Techniques on Posture and Respiratory Function in Parkinson's Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Camptocormia, Restrictive Lung Disease
Keywords
Rehabilitation, Posture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups with sham control group
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal mobilization group
Arm Type
Active Comparator
Arm Description
Spinal mobilization will be applied to the application group for 4 weeks in addition to the treatments applied to the sham group
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
Diaphragmatic stimulation with proprioceptive neuromuscular facilitation techniques (PNF), diaphragmatic breathing techniques, costal mobilization treatments and sham mobilization will be applied to the sham group.
Intervention Type
Other
Intervention Name(s)
Diaphragmatic stimulation treatment with PNF techniques
Intervention Description
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
Intervention Name(s)
Costal mobilization
Intervention Description
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
Intervention Name(s)
Breathing exercises
Intervention Description
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
Intervention Name(s)
Spinal mobilization
Intervention Description
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
Intervention Name(s)
Sham mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary Function Test
Description
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.
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Spinal Mouse Evaluation
Description
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
Time Frame
Four weeks
Title
Camptocormia and Range of Motion Evaluations
Description
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.
Time Frame
Four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have been diagnosed with Parkinson's disease Volunteering to participate in the study 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramazan Kurul, Ph.D
Phone
+905436414731
Email
ramazankurul2@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Enes Tayyip Benli, MSc
Phone
+905387359268
Email
enestayyipbenli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramazan Kurul, Ph.D
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abant Izzet Baysal University Faculty of Health Science
City
Bolu
ZIP/Postal Code
14100
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramazan Kurul, Ph.D
Phone
+905436414731
Email
ramazankurul2@hotmail.com
First Name & Middle Initial & Last Name & Degree
Enes Tayyip Benli, MSc
Phone
+905387359268
Email
enestayyipbenli@gmail.com
Facility Name
AIBU Physical Therapy and Rehabiltiation Department
City
Bolu
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramazan Kurul, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

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

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