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NCT Number: NCT05342025

Proprioceptive Neuromuscular Facilitation in Multiple Sclerosis

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.

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Key information

Conditions

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

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Forced expiratory volume 1st second

    Time frame: 8 weeks

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

  2. Peak cough flow

    Time frame: 8 weeks

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

  3. Respiratory muscle strength

    Time frame: 8 weeks

    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.

  4. Forced vital capacity

    Time frame: 8 weeks

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

Secondary outcomes

  1. 2 Minutes Walking Test

    Time frame: 8 weeks

    The 2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity[1], particularly for those who cannot manage the longer Six Minute Walk Test (6MWT) or 12 Minute Walk Test.

  2. Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)

    Time frame: 8 weeks

    It is a disease-specific quality of life scale and consists of a total of 31 questions, including 3 subheadings: psychological, physical and psychosocial.

  3. Eating Assessment Tool (EAT-10)

    Time frame: 8 weeks

    It is used to evaluate dysphagia symptom severity and response to treatment. The single-factor scale consists of 10 items scored between 0-4.

  4. Fatigue Severity Scale (Fatigue Severity Scale)

    Time frame: 8 weeks

    The scale consists of 9 questions that evaluate fatigue and are scored between 1-7. High scores indicate increased fatigue.

  5. Dysphagia Rating Scale in Multiple Sclerosis (DYMUS)

    Time frame: 8 weeks

    The scale is used in the evaluation of oropharyngeal dysphagia in patients with MS.DYMUS is a 10-item questionnaire; all the answers are dichotomous, coded as 1 or 0, depending on the presence or the absence of the event

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

Investigation Of The Effects Of Proprioceptive Neuromuscular Facilitation Techniques For Upper Extremity And Trunk, Combined With Respiration, On Respiratory Capacity And Swallowing In Individuals With Multiple Sclerosis

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 22, 2022
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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