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Proprioceptive Neuromuscular Facilitation in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PNF
Breathing exercises
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring respiratory function, swallowing, proprioceptive neuromuscular facilitation

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Biruni University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PNF group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Forced expiratory volume 1st second
Spirometric assessment will be performed to determine participants' forced expiratory volume in one second (FEV1).
Peak cough flow
Peak cough flow (PEF) will be measured in triplicate during the "maximal coughing manoeuvre" with a digital PEFmeter.
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.
Forced vital capacity
Spirometric assessment will be performed to determine participants' forced vital capacity (FVC).

Secondary Outcome Measures

2 Minutes Walking Test
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.
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)
It is a disease-specific quality of life scale and consists of a total of 31 questions, including 3 subheadings: psychological, physical and psychosocial.
Eating Assessment Tool (EAT-10)
It is used to evaluate dysphagia symptom severity and response to treatment. The single-factor scale consists of 10 items scored between 0-4.
Fatigue Severity Scale (Fatigue Severity Scale)
The scale consists of 9 questions that evaluate fatigue and are scored between 1-7. High scores indicate increased fatigue.
Dysphagia Rating Scale in Multiple Sclerosis (DYMUS)
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

Full Information

First Posted
April 14, 2022
Last Updated
May 11, 2023
Sponsor
Biruni University
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1. Study Identification

Unique Protocol Identification Number
NCT05342025
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
respiratory function, swallowing, proprioceptive neuromuscular facilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The assessor will be blind to the randomization and the investigator will be blind to the results of the assessments.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PNF group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PNF
Intervention Description
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
Intervention Name(s)
Breathing exercises
Intervention Description
Breathing exercises: diaphragmatic breathing, thoracic expansion, pursed-lip breathing and respiratory control for 15 minutes a day, every day of the week.
Primary Outcome Measure Information:
Title
Forced expiratory volume 1st second
Description
Spirometric assessment will be performed to determine participants' forced expiratory volume in one second (FEV1).
Time Frame
8 weeks
Title
Peak cough flow
Description
Peak cough flow (PEF) will be measured in triplicate during the "maximal coughing manoeuvre" with a digital PEFmeter.
Time Frame
8 weeks
Title
Respiratory muscle strength
Description
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.
Time Frame
8 weeks
Title
Forced vital capacity
Description
Spirometric assessment will be performed to determine participants' forced vital capacity (FVC).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
2 Minutes Walking Test
Description
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.
Time Frame
8 weeks
Title
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)
Description
It is a disease-specific quality of life scale and consists of a total of 31 questions, including 3 subheadings: psychological, physical and psychosocial.
Time Frame
8 weeks
Title
Eating Assessment Tool (EAT-10)
Description
It is used to evaluate dysphagia symptom severity and response to treatment. The single-factor scale consists of 10 items scored between 0-4.
Time Frame
8 weeks
Title
Fatigue Severity Scale (Fatigue Severity Scale)
Description
The scale consists of 9 questions that evaluate fatigue and are scored between 1-7. High scores indicate increased fatigue.
Time Frame
8 weeks
Title
Dysphagia Rating Scale in Multiple Sclerosis (DYMUS)
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buket AKINCI, Assoc.Prof.
Organizational Affiliation
Biruni University
Official's Role
Study Chair
Facility Information:
Facility Name
Biruni University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Proprioceptive Neuromuscular Facilitation in Multiple Sclerosis

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