Myasthenia GravisNCT06158815
Investigation of the Effects of Proprioceptive Neuromuscular Facilitation Exercises in Patients With Myasthenia Gravis
A study testing proprioceptive neuromuscular facilitation exercise in people with Myasthenia Gravis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to investigate of the effects of proprioceptive neuromuscular facilitation exercises on fatigue, muscle strength and functional parameters in patient with Myasthenia Gravis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- proprioceptive neuromuscular facilitation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Nov 2023to 25 Dec 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study
- Being between the ages of 18-65
- It must be confirmed by the Neurologist that the patient has been diagnosed with adult onset and Achr+ generalized Myasthenia Gravis and has been in a stable condition for the last 6 months.
- Being in class II or III according to the American Myasthenia Gravis Foundation Clinical Classification
Who cannot join
- Having a cognitive problem or having a Mini Mental Test score below 24
- Change in the type and dose of medical treatment within the last 6 months
- Having another cardiorespiratory, metabolic, systemic, rheumatological, orthopaedic and neurological disease (unstable and at a level that prevents participation in the exercise programme) in addition to Myasthenia Gravis
- Having a body mass index below 17 kg/m2 and above 30 kg/m2
- Having participated in any physiotherapy program any intervention study for the last 6 months
- Having undergone pregnancy, birth or surgical operation in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, Altındag, 06230
About this study
Official title: Investigation of the Effects of Proprioceptive Neuromuscular Facilitation Exercises on Fatigue, Muscle Strength and Functional Parameters in Patients With Myasthenia Gravis
The goal of this clinical trial is to investigate of the effects of proprioceptive neuromuscular facilitation exercises on fatigue, muscle strength and functional parameters in patient with Myasthenia Gravis. The main questions it aims to answer are:
- Do proprioceptive neuromuscular facilitation exercises reduce fatigue in patients with Myasthenia Gravis?
- Do proprioceptive neuromuscular facilitation exercises increase muscle strength in patients with Myasthenia Gravis?
- Do proprioceptive neuromuscular facilitation exercises improve functional parameters in patients with Myasthenia Gravis?
- How well can patients with Myasthenia Gravis tolerate proprioceptive neuromuscular facilitation exercises? Participants will be divided into 2 groups as control group and exercise group with block randomization method. In this single-blind randomized controlled study, the participants in the control group will be placed on a waiting list without any intervention during the 6-week study period and at the end of the study, the interventions applied to the exercise group will be applied exactly the same. Proprioceptive neuromuscular facilitation exercises will be applied to the exercise group 3 days a week, 1 hour a day for 6 weeks. Individuals will be evaluated at the beginning and at the end of the study.
Researchers will compare exercise and control group to see if there are effects of proprioceptive neuromuscular exercises patients with Myasthenia Gravis.
- Conditions
- Myasthenia Gravis
- Being tested
- proprioceptive neuromuscular facilitation exercise
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proprioceptive neuromuscular facilitation exerciseOther
The basic principle of Proprioceptive Neuromuscular Facilitation exercises, which is defined as facilitating the responses of the neuromuscular mechanism by stimulating the proprioceptors, is that the movements in the human body have a rotational and oblique character and that a greater response can be obtained with movement against maximum resistance. It is aimed to achieve improvement in strength and movement ability through hand contacts, visual and verbal stimuli.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Participants in the control group will be placed on a waiting list without any intervention during the 6-week study period. |
| exercise group | Experimental | Participants in the exercise group will have face-to-face Proprioceptive Neuromuscular Facilitation Exercises during the 6-week study period. Receives: Other: proprioceptive neuromuscular facilitation exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
chalder fatigue scale
It is an easy, fast and useful scale that evaluates fatigue through self-report. The final version of the scale consists of a total of 11 items, including a 7-item physical fatigue subsection and a 4-item mental fatigue subsection. The individual is asked to respond to the statements using a four-point Likert scale (less than usual, as much as usual, more than usual, much more than usual). Each item is scored between 0-3 and the total score varies between 0-33.
Measured: baseline and immediately after the intervention
Fatigue Impact Scale
It is a multidimensional scale that evaluates the physical, cognitive and social effects of fatigue. The scale consists of a total of 40 questions: 10 questions for the physical effects subscale, 10 questions for the cognitive effects subscale, and 20 questions for the social effects subscale. Individuals fill out the scale by taking their last month into consideration. All questions are scored from "0" (no problem) to "4" (very big problem). Higher scores indicate increased degree of fatigue.
Measured: baseline and immediately after the intervention
fatigue severity scale
It is a self-report scale consisting of 9 items that evaluates the degree of fatigue severity in the last week. For each item, the patient marks the most appropriate statement on a 7-point Likert scale ranging from 7=strongly agree to 1=strongly disagree. The scores obtained from each item are added up and the total value is divided by 9.
Measured: baseline and immediately after the intervention
Surface electromyography
Surface electromyography measurements will be performed to measure the electrical signals coming from the muscles to determine the fatigue of the muscles. It has been shown in the literature that fatigue can be measured by power spectrum analysis in neuromuscular diseases. For this purpose, surface electromyography electrodes will be placed on the vastus lateralis muscle and the middle part of the deltoideus muscle and the participants will be asked to make maximum isometric contraction for 30 seconds. Electromyography signals will be analyzed and median frequencies between 0-5 seconds and 25-30 seconds will be determined and recorded. Wireless surface electromyography sensors and portable data acquisition system will be used to record and store measurements (Delsys (Delsys Inc. Natick, Massachusetts, USA)).
Measured: baseline and immediately after the intervention
Six Minute Walk Test
It will be applied to evaluate functional capacity in accordance with the guidelines of the American Thoracic Society. In this test, the participant is walked down a 30-meter straight corridor. Participants are asked to walk for 6 minutes at the maximum speed they can walk during the test. The total distance walked is recorded. The distance walked per minute will also be recorded during this test. From these data, physical fatigue will be calculated according to the fatigue ambulatory index formula.
Measured: baseline and immediately after the intervention
Secondary outcomes (6)
muscle strength
The upper extremity, lower extremity and neck muscles of the participants will be evaluated using a digital hand dynamometer (Lafayette Manual Muscle Tester Model 01165, Lafayette Instrument Company, Lafayette, IN, USA). Muscle strength measurements will be evaluated by applying a breaking test to measure maximum muscle strength, with a digital hand dynamometer placed between the patient's evaluating area and the physiotherapist's hand, depending on the principles and positions of manual muscle testing. In the upper extremities; shoulder flexors, shoulder extensors, shoulder abductors, elbow flexors and extensors, in the lower extremities; hip flexors, hip extensors, hip abductors, knee flexors and extensors will be evaluated. In the cervical region, both flexor and extensor muscle groups will be evaluated and recorded. Three measurements will be made for all muscles and the average value will be recorded.
Measured: baseline and immediately after the intervention
functional capacity
Two timed performance tests will be used: the 30-second sit-to-stand test and the stair-climbing test. In the 30-second sit-to-stand test, the participant is asked to sit on a standard chair for 30 seconds. The participant is asked to sit and stand as many times as possible throughout the session. The number of repetitions performed within a 30-second period will be recorded. In the stair climbing test, the participant will be asked to climb 10 standard steps as quickly as possible. The time it takes to climb 10 steps will be recorded in seconds. Both methods are used to determine functional capacity in patients with Myasthenia Gravis.
Measured: baseline and immediately after the intervention
Myasthenia Gravis-Activities of Daily Living Scale
It is a self-report scale consisting of eight items. It is designed to evaluate the functional performance of daily living activities impaired due to Myasthenia Gravis. Two of the items in the scale consist of ocular, three bulbar, one respiratory, and two extremity-related activities. Each item is rated from 0 to 3, and the total score range is 0 to 24. High scores indicate low independence.
Measured: baseline and immediately after the intervention
Myasthenia Gravis Quality of Life Scale
It is a self-report scale consisting of fifteen items. It is designed to evaluate the change in quality of life due to Myasthenia Gravis. Items in the scale are scored between 0 and 4, and the total score range is 0-60. The higher the score, the worse the patient's perceived quality of life.
Measured: baseline and immediately after the intervention
Myasthenia Gravis Composite Scale
It is a scale developed to determine disease severity, applied and scored by healthcare professionals. Myasthenia Gravis Composite Scale scoring is created by combining parts of three scales. Ocular evaluation was obtained from the Quantitative Myasthenia Gravis Scale, bulbar and neck flexion evaluations were obtained from the Myasthenia Gravis Activity of Daily Living Scale, and muscle strength tests were obtained from the Manual Muscle Test scale. Total score varies between 0-50. Higher scores indicate increased disease severity.
Measured: baseline and immediately after the intervention
visual analog scale
How well patients can tolerate Proprioceptive Neuromuscular Facilitation Exercises and their satisfaction with the treatment will be evaluated with 4 visual analog scales. Visual Analogue Scale consists of a 100 mm line. At each end of the line, there are two opposing statements about the situation to be evaluated. The participant is asked to mark the point on the visual analog scale line that best reflects his or her feelings. The point marked by the participant is measured in cm or mm from the end point with the help of a ruler.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start23 Nov 2023
- Primary completion9 Jul 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ridvan muhammed adin, Hacettepe University
- Investigators
- sevim erdem özdamar, Professor, Principal investigator, Hacettepe Universityyeliz salcı, Assoc. Prof., Study chair, Hacettepe Universityrıdvan m adın, M.Sc., Study chair, Hacettepe Universityayla fil balkan, Assoc. Prof., Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158815
- Sponsor's protocol ID
- KA-22017
- Status last verified
- Aug 2026
- First submitted
- 22 Nov 2023
- Last updated
- 27 Aug 2026
- 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Proprioceptive Neuromuscular Facilitation Exercises on Fatigue, Muscle Strength and Functional Parameters in Patients With Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT06158815
- Acronym / sponsor ID
- KA-22017
- Conditions
- Myasthenia Gravis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 6 Dec 2023 (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.
The goal of this clinical trial is to investigate of the effects of proprioceptive neuromuscular facilitation exercises on fatigue, muscle strength and functional parameters in patient with Myasthenia Gravis. The main questions it aims to answer are:
- Do proprioceptive neuromuscular facilitation exercises reduce fatigue in patients with Myasthenia Gravis?
- Do proprioceptive neuromuscular facilitation exercises increase muscle strength in patients with Myasthenia Gravis?
- Do proprioceptive neuromuscular facilitation exercises improve functional parameters in patients with Myasthenia Gravis?
- How well can patients with Myasthenia Gravis tolerate proprioceptive neuromuscular facilitation exercises? Participants will be divided into 2 groups as control group and exercise group with block randomization method. In this single-blind randomized controlled study, the participants in the control group will be placed on a waiting list without any intervention during the 6-week study period and at the end of the study, the interventions applied to the exercise group will be applied exactly the same. Proprioceptive neuromuscular facilitation exercises will be applied to the exercise group 3 days a week, 1 hour a day for 6 weeks. Individuals will be evaluated at the beginning and at the end of the study.
Researchers will compare exercise and control group to see if there are effects of proprioceptive neuromuscular exercises patients with Myasthenia Gravis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Participants in the control group will be placed on a waiting list without any intervention during the 6-week study period. |
| exercise group | Experimental | Other: proprioceptive neuromuscular facilitation exerciseParticipants in the exercise group will have face-to-face Proprioceptive Neuromuscular Facilitation Exercises during the 6-week study period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteering to participate in the study
- Being between the ages of 18-65
- It must be confirmed by the Neurologist that the patient has been diagnosed with adult onset and Achr+ generalized Myasthenia Gravis and has been in a stable condition for the last 6 months.
- Being in class II or III according to the American Myasthenia Gravis Foundation Clinical Classification
Key exclusion criteria (6 listed)
- Having a cognitive problem or having a Mini Mental Test score below 24
- Change in the type and dose of medical treatment within the last 6 months
- Having another cardiorespiratory, metabolic, systemic, rheumatological, orthopaedic and neurological disease (unstable and at a level that prevents participation in the exercise programme) in addition to Myasthenia Gravis
- Having a body mass index below 17 kg/m2 and above 30 kg/m2
- Having participated in any physiotherapy program any intervention study for the last 6 months
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 |
|---|---|---|
| proprioceptive neuromuscular facilitation exerciseThe basic principle of Proprioceptive Neuromuscular Facilitation exercises, which is defined as facilitating the responses of the neuromuscular mechanism by stimulating the proprioceptors, is that the movements in the human body have a rotational and oblique character and that a greater response can be obtained with movement against maximum resistance. It is aimed to achieve improvement in strength and movement ability through hand contacts, visual and verbal stimuli. | Other | exercise group |
Primary outcome
chalder fatigue scale
Time frame: baseline and immediately after the intervention
It is an easy, fast and useful scale that evaluates fatigue through self-report. The final version of the scale consists of a total of 11 items, including a 7-item physical fatigue subsection and a 4-item mental fatigue subsection. The individual is asked to respond to the statements using a four-point Likert scale (less than usual, as much as usual, more than usual, much more than usual). Each item is scored between 0-3 and the total score varies between 0-33.
Fatigue Impact Scale
Time frame: baseline and immediately after the intervention
It is a multidimensional scale that evaluates the physical, cognitive and social effects of fatigue. The scale consists of a total of 40 questions: 10 questions for the physical effects subscale, 10 questions for the cognitive effects subscale, and 20 questions for the social effects subscale. Individuals fill out the scale by taking their last month into consideration. All questions are scored from "0" (no problem) to "4" (very big problem). Higher scores indicate increased degree of fatigue.
fatigue severity scale
Time frame: baseline and immediately after the intervention
It is a self-report scale consisting of 9 items that evaluates the degree of fatigue severity in the last week. For each item, the patient marks the most appropriate statement on a 7-point Likert scale ranging from 7=strongly agree to 1=strongly disagree. The scores obtained from each item are added up and the total value is divided by 9.
Surface electromyography
Time frame: baseline and immediately after the intervention
Surface electromyography measurements will be performed to measure the electrical signals coming from the muscles to determine the fatigue of the muscles. It has been shown in the literature that fatigue can be measured by power spectrum analysis in neuromuscular diseases. For this purpose, surface electromyography electrodes will be placed on the vastus lateralis muscle and the middle part of the deltoideus muscle and the participants will be asked to make maximum isometric contraction for 30 seconds. Electromyography signals will be analyzed and median frequencies between 0-5 seconds and 25-30 seconds will be determined and recorded. Wireless surface electromyography sensors and portable data acquisition system will be used to record and store measurements (Delsys (Delsys Inc. Natick, Massachusetts, USA)).
Six Minute Walk Test
Time frame: baseline and immediately after the intervention
It will be applied to evaluate functional capacity in accordance with the guidelines of the American Thoracic Society. In this test, the participant is walked down a 30-meter straight corridor. Participants are asked to walk for 6 minutes at the maximum speed they can walk during the test. The total distance walked is recorded. The distance walked per minute will also be recorded during this test. From these data, physical fatigue will be calculated according to the fatigue ambulatory index formula.
6 secondary outcomes
muscle strength
Time frame: baseline and immediately after the intervention
functional capacity
Time frame: baseline and immediately after the intervention
Myasthenia Gravis-Activities of Daily Living Scale
Time frame: baseline and immediately after the intervention
Myasthenia Gravis Quality of Life Scale
Time frame: baseline and immediately after the intervention
Myasthenia Gravis Composite Scale
Time frame: baseline and immediately after the intervention
visual analog scale
Time frame: immediately after the intervention
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 27 Aug 2026.
- 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.
sevim erdem özdamar, Professor principal investigator
Hacettepe University
yeliz salcı, Assoc. Prof. study chair
Hacettepe University
rıdvan m adın, M.Sc. study chair
Hacettepe 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 proprioceptive neuromuscular facilitation exercise in people with Myasthenia Gravis, run by Hacettepe 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 4 inclusion and 6 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 27 Aug 2026. 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?
chalder fatigue scale (time frame: baseline and immediately after the intervention). The study lists 5 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 27 Aug 2026.