Clinical trial NCT05342025: Proprioceptive Neuromuscular Facilitation in Multiple Sclerosis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: respiratory function
swallowing
proprioceptive neuromuscular facilitation
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 34
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Forced expiratory volume 1st second
timeFrame: 8 weeks
measure: Peak cough flow
timeFrame: 8 weeks
measure: Respiratory muscle strength
timeFrame: 8 weeks
measure: Forced vital capacity
timeFrame: 8 weeks
Secondary outcomes:
measure: 2 Minutes Walking Test
timeFrame: 8 weeks
measure: Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)
timeFrame: 8 weeks
measure: Eating Assessment Tool (EAT-10)
timeFrame: 8 weeks
measure: Fatigue Severity Scale (Fatigue Severity Scale)
timeFrame: 8 weeks
measure: Dysphagia Rating Scale in Multiple Sclerosis (DYMUS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Biruni University
name: Buket AKINCI, Assoc.Prof.
role: STUDY_CHAIR
References: