Proprioceptive Neuromuscular Facilitation in Multiple Sclerosis

NCT ID: NCT05342025

Last Updated: 2023-05-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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Among the physiotherapy and rehabilitation approaches applied for the problems affecting the quality of life in Multiple Sclerosis; Exercises for muscle strength loss, balance coordination exercises, electrical stimulation, orthotic approaches, breathing and swallowing exercises, and Proprioceptive Neuromuscular Facilitation (PNF) techniques are included. Among the respiratory dysfunctions are seen in MS patients: abnormal respiratory control, respiratory muscle weakness, bulbar dysfunction/respiratory failure, and sleep breathing disorders can be cited as examples. Significant expiratory weakness develops in MS patients with the progression of the disease, and the accompanying upper extremity involvement exacerbates this problem. It should not be ignored that swallowing-respiratory coordination and ultimately swallowing can be affected by the deterioration of respiration in MS patients. Among the neurophysiological approaches, the PNF technique; is known to have positive effects on tidal volume, respiratory rate, and minute ventilation parameters in neurological patients. Respiratory patterns of PNF can be applied alone or in combination with other extremity patterns. This study aims to examine the effect of using PNF breathing techniques in combination with upper extremity and trunk on MS patients on respiratory and swallowing functions.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The assessor will be blind to the randomization and the investigator will be blind to the results of the assessments.

Study Groups

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PNF group

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.

Group Type EXPERIMENTAL

PNF

Intervention Type 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.

Control Group

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.

Group Type ACTIVE_COMPARATOR

Breathing exercises

Intervention Type OTHER

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

Interventions

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PNF

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.

Intervention Type OTHER

Breathing exercises

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biruni University

OTHER

Sponsor Role lead

Responsible Party

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Buket AKINCI

Assoc.Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Buket AKINCI, Assoc.Prof.

Role: STUDY_CHAIR

Biruni University

Locations

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Biruni University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2015-KAEK-57-21-02

Identifier Type: -

Identifier Source: org_study_id

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