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

NCT04941326 | Recruiting

• 1 other identifier: AIBU-FTR-ETB-001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease; Camptocormia; Restrictive Lung Disease

Keywords

Rehabilitation; Posture

Outcome Measures

Primary Outcomes (1)

• 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.

  Four weeks

Secondary Outcomes (3)

• Spinal Mouse Evaluation

  Four weeks

• Camptocormia and Range of Motion Evaluations

  Four weeks

• Ultrasonography

  Four weeks

Study Arms (2)

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

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.

Other: Diaphragmatic stimulation treatment with PNF techniques; Other: Costal mobilization; Other: Breathing exercises; Other: Sham mobilization

Interventions

Diaphragmatic stimulation treatment with PNF techniques 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.

Sham group; Spinal mobilization group

Costal mobilization 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.

Sham group; Spinal mobilization group

Breathing exercises 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 group; Spinal mobilization group

Spinal mobilization 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.

Spinal mobilization group

Sham mobilization 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.

Sham group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (2)

Abant Izzet Baysal University Faculty of Health Science

Bolu, 14100, Turkey (Türkiye)

NOT YET RECRUITING

AIBU Physical Therapy and Rehabiltiation Department

Bolu, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Camptocormia

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Ramazan Kurul, Ph.D

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramazan Kurul, Ph.D

CONTACT

+905436414731; ramazankurul2@hotmail.com

Enes Tayyip Benli, MSc

CONTACT

+905387359268; enestayyipbenli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participans and outcome assessors will be blinded to group allocation. Control group will receive same amount of sham mobilisations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two groups with sham control group

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 28, 2021
• Study Start: August 15, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)