Proprioceptive Neuromuscular Facilitation in Multiple Sclerosis

NCT05342025 | Completed

• 1 other identifier: 2015-KAEK-57-21-02
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple Sclerosis (MS) is an autoimmune central nervous system disease characterized by inflammation, demyelination, and axonal degeneration. Clinical symptoms of the disease include fatigue, speech, breathing, and swallowing problems. Although respiratory issues are less common in patients with MS, pulmonary complications are among the most common causes of mortality and morbidity in the terminal period. Although it is known that expiratory and inspiratory respiratory muscle training is beneficial in MS disease, the protocols used are variable and there is no standard exercise protocol. Respiratory muscle training is one of the instrument-oriented techniques, and the issue of delivering these devices to each patient creates a cost disadvantage. It is foreseen that the preference for the PNF technique to be applied in combination with respiration in the project will enable the development of alternative treatment approaches in order to solve the researched problems in MS disease, which is a critical health problem. Proprioceptive Neuromuscular Facilitation (PNF) is defined as facilitating the responses of the neuromuscular mechanism by stimulating the proprioceptors. In the literature, there is no study examining the effectiveness of PNF on respiratory and swallowing functions in individuals with MS. The aim of the study is to investigate the effects of PNF application in combination with upper extremity and trunk patterns on respiratory and swallowing functions in patients with MS.

Conditions

Multiple Sclerosis

Keywords

respiratory function; swallowing; proprioceptive neuromuscular facilitation

Outcome Measures

Primary Outcomes (4)

• Forced expiratory volume 1st second

  Spirometric assessment will be performed to determine participants' forced expiratory volume in one second (FEV1).

  8 weeks

• Peak cough flow

  Peak cough flow (PEF) will be measured in triplicate during the "maximal coughing manoeuvre" with a digital PEFmeter.

  8 weeks

• Respiratory muscle strength

  The respiratory muscle strength measurement of the participants will be made with an intraoral pressure measuring device, an intraoral pressure gauge. Maximal inspiratory and expiratory pressures will be measured.

  8 weeks

• Forced vital capacity

  Spirometric assessment will be performed to determine participants' forced vital capacity (FVC).

  8 weeks

Secondary Outcomes (5)

• 2 Minutes Walking Test

  8 weeks

• Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)

  8 weeks

• Eating Assessment Tool (EAT-10)

  8 weeks

• Fatigue Severity Scale (Fatigue Severity Scale)

  8 weeks

• Dysphagia Rating Scale in Multiple Sclerosis (DYMUS)

  8 weeks

Study Arms (2)

PNF group

EXPERIMENTAL

PNF will be applied to the trunk and upper extremities combined with breathing, 3 times a week, 1 hour a day for 6 weeks. The physiotherapist will apply pressure and stretches to the chest wall and diaphragm for 20 seconds by giving verbal commands to the patient for the inspiration/expiratory phases. The physiotherapist will apply patterns over the 2nd and 3rd ribs in a bilateral anterior manner including intercostal stretches.

Other: PNF

Control Group

ACTIVE COMPARATOR

Individuals in this group will be taught breathing exercises (diaphragmatic breathing, thoracic expansion, pursed-lip breathing, and respiratory control) after the assessments, and they will be informed about performing breathing exercises for 15 minutes a day, every day of the week. Patients will be asked to keep a "treatment diary" to control regular breathing exercises. Individuals will be re-evaluated after 2 months.

Other: Breathing exercises

Interventions

PNF OTHER

PNF will be applied to the trunk and upper extremities combined with breathing, 3 times a week, 1 hour a day for 6 weeks. Breathing PNF patterns, pressure, and stretches will be applied inward and upwards into the rib cage so that they do not cause pain. Diaphragmatic stimulation will be performed on both sides with repeated contractions, hand contacts, and stabilization techniques. Facilitation techniques will be used to stimulate the intrinsic respiratory muscles. Again, with respect to inspiration, the patterns will be studied in neck extension, upper and lower trunk extension, and upper extremities flexion patterns. Neck flexion, upper and lower trunk flexion, and extension patterns of the upper extremities will be applied in relation to expiration. The physiotherapist will apply pressure and stretches to the chest wall and diaphragm for 20 seconds by giving verbal commands to the patient for the inspiration/expiratory phases.

PNF group

Breathing exercises OTHER

Breathing exercises: diaphragmatic breathing, thoracic expansion, pursed-lip breathing and respiratory control for 15 minutes a day, every day of the week.

Control Group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 25-55,
• MS was diagnosed by a neurologist,
• Expanded Disability Status Scale (EDSS) - Expanded Disability Status Scale (EDSS) score between 1-5,
• Have not had an attack in the last 3 months,
• Have not participated in any respiratory-based physiotherapy and rehabilitation program in the last 6 months,
• Not having orthopedic problems, persistent neck pain and/or radiculopathy that would prevent them from participating in the study,
• Individuals willing to participate in the study will be included.

You may not qualify if:

• Having chest wall deformity,
• Having chronic cardiac or pulmonary disease such as COPD, asthma, interstitial lung disease and heart failure that may affect respiratory muscle strength and respiratory functions,
• Having pneumonia due to viral or bacterial infection in the last 6 months,
• Having COVID-19,
• Having a diagnosed psychiatric disorder,
• Using tobacco and tobacco products,
• Individuals with cooperation problems that may hinder assessments and treatment will not be included.

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Respiratory Aspiration

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Buket AKINCI, Assoc.Prof.

  Biruni University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The assessor will be blind to the randomization and the investigator will be blind to the results of the assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof. Dr.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 22, 2022
• Study Start: May 1, 2022
• Primary Completion: November 15, 2022
• Study Completion: April 1, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)