Multiple SclerosisNCT05342025
Proprioceptive Neuromuscular Facilitation in Multiple Sclerosis
A study testing PNF and Breathing exercises in people with Multiple Sclerosis, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- PNF and Breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- PNF, Breathing exercises
- Keywords
- respiratory function, swallowing, proprioceptive neuromuscular facilitation
- Medical subject headings
- Multiple Sclerosis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNFOther
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 exercisesOther
Breathing exercises: diaphragmatic breathing, thoracic expansion, pursed-lip breathing and respiratory control for 15 minutes a day, every day of the week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume 1st second
Spirometric assessment will be performed to determine participants' forced expiratory volume in one second (FEV1).
Measured: 8 weeks
Peak cough flow
Peak cough flow (PEF) will be measured in triplicate during the "maximal coughing manoeuvre" with a digital PEFmeter.
Measured: 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.
Measured: 8 weeks
Forced vital capacity
Spirometric assessment will be performed to determine participants' forced vital capacity (FVC).
Measured: 8 weeks
Secondary outcomes (5)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 May 2022
- Primary completion15 Nov 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
- Investigators
- Buket AKINCI, Assoc.Prof., Study chair, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342025
- Sponsor's protocol ID
- 2015-KAEK-57-21-02
- Status last verified
- May 2023
- First submitted
- 14 Apr 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05342025
- Acronym / sponsor ID
- 2015-KAEK-57-21-02
- Conditions
- Multiple Sclerosis
- Keywords
- respiratory function, swallowing, proprioceptive neuromuscular facilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNF group | Experimental | Other: PNFPNF 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. |
| Control Group | Active comparator | Other: Breathing exercisesIndividuals 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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNFPNF 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. | Other | PNF group |
| Breathing exercisesBreathing exercises: diaphragmatic breathing, thoracic expansion, pursed-lip breathing and respiratory control for 15 minutes a day, every day of the week. | Other | Control Group |
Primary outcome
Forced expiratory volume 1st second
Time frame: 8 weeks
Spirometric assessment will be performed to determine participants' forced expiratory volume in one second (FEV1).
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.
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.
Forced vital capacity
Time frame: 8 weeks
Spirometric assessment will be performed to determine participants' forced vital capacity (FVC).
5 secondary outcomes
2 Minutes Walking Test
Time frame: 8 weeks
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)
Time frame: 8 weeks
Eating Assessment Tool (EAT-10)
Time frame: 8 weeks
Fatigue Severity Scale (Fatigue Severity Scale)
Time frame: 8 weeks
Dysphagia Rating Scale in Multiple Sclerosis (DYMUS)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buket AKINCI, Assoc.Prof. study chair
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF and Breathing exercises in people with Multiple Sclerosis, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume 1st second (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.