Multiple SclerosisNCT06198972
Pelvic Proprioceptive Neuromuscular Facilitation (PNF) Exercises in Multiple Sclerosis Patients
A study testing Pelvic Pnf exercises and Strength exercises in people with Multiple Sclerosis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Multiple Sclerosis (MS) is an autoimmune, demyelinating disease that progresses with motor and sensory loss of the central nervous system and causes disability at different levels. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Pelvic Pnf exercises and Strength exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 15 Mar 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Consent for the study was obtained;
- Between 18-50 years of age,
- Extended Disability Status Scale (EDSS) score of 4 and below,
- Not in the habit of exercising regularly
- Can walk on the treadmill,
- Not pregnant,
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- Not receiving corticosteroid treatment in the last 1 month,
- Fampridine etc. in the last month. not taking medication,
- Patients who have not received Botox treatment in the last 6 months will be included.
Who cannot join
- Individuals who cannot tolerate the treatment programs and cannot ensure their continuity (2 weeks in a row) will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep Islam Science and Technology University
Gaziantep
About this study
Official title: The Effect of Pelvic Proprioceptive Neuromuscular Facilitation (PNF) Exercises on Strength, Balance and Walking Skills in Multiple Sclerosis Patients.
Multiple Sclerosis (MS) is an autoimmune, demyelinating disease that progresses with motor and sensory loss of the central nervous system and causes disability at different levels. Although signs and symptoms vary depending on the location of the lesion, findings such as loss of muscle strength, spasticity, sensory disorders and fatigue cause decreases in walking function in the majority of patients. Loss of muscle strength and fatigue cause loss of mobility, causing individuals with MS to be less physically active than healthy adults in the same age group. As a result, approximately 40% of individuals with MS have walking problems and approximately 70% of them experience a decrease in daily living activities. Literature studies frequently include strengthening exercises for lower extremity muscles in MS patients. However, the results of pelvic pattern exercises, which are the key to lower extremity movements, are not specified. In this study, which is planned in the light of this information, the findings obtained from pelvic PNF exercises will serve to fill this gap in the literature.
Read the detailed description
According to the data of the Turkish Neurology Association, it is estimated that there are approximately 40,000 MS patients in Turkey. The fact that it is the most common neurological disease in young adults further increases the importance of the need for effective treatment programs.
Exercise training, which aims to improve the functional losses caused by the disease, constitutes a very important part of rehabilitation protocols. For example, while the effects of resistant exercise training have been investigated in athletes and healthy individuals, no definitive results have been obtained regarding correct and effective exercise approaches in MS.
The basic principle of proprioceptive neuromuscular facilitation techniques, defined as facilitating the responses of the neuromuscular mechanism by stimulating the proprioceptors and briefly expressed as PNF, is based on the principle that physiological movements in the human body have rotational and oblique characters and that a greater response can be achieved with movements performed against maximum resistance.
It consists of the pelvis, sacrum, innominate bones (ilium, ischium, pubis) and coccyx. The vertebral column is directly connected to the lower extremities through the sacroiliac joint and is a weight-bearing structure. Pelvic patterns are in harmony with lower extremity patterns. Because the pelvis actually consists of different functional structures and is in relationship with the lower extremities through the hip joint. Pelvic movements and stability are necessary for adequate function of both the trunk and lower extremities. The therapeutic purposes of pelvic patterns are as follows;
- Pelvic movements and stabilization,
- Body stabilization and movements,
- Rotation etc. functional activities,
- To improve lower extremity movements and stabilization Studies conducted on multiple sclerosis patients indicate that walking patterns differ compared to healthy individuals of the same age. Therefore, the main aim of MS rehabilitation is to maintain walking ability and ensure mobility. To this end; Muscle strength, especially proximal muscles, needs to be increased. Also MS; It is a neurological disease that affects the structures responsible for maintaining balance, such as muscle strength and tone, sensory perception, vision and cognition. For this reason, it is reported that balance and gait control are impaired in approximately 80% of MS patients, increasing the number of falls of patients. Because MS disease involves many areas such as the cerebral hemisphere, brainstem and spinal cord, the cause of balance loss may vary from patient to patient. Balance; It is a response formed jointly by visual, sensory, vestibular systems and motor responses. It is complex because of the way systems work together. There is no definitive evidence as to which system is more effective. However, studies have shown that there is a relationship between loss of muscle strength and decreased walking speed and balance problems. It is stated that lower extremity muscle strength is effective on balance because it supports mobility the most and also plays a fundamental role in sensoriomotor functions.
Literature studies frequently include strengthening exercises for lower extremity muscles in MS patients. However, the results of pelvic pattern exercises, which are the key to lower extremity movements, are not specified. In this study, which we planned in the light of this information, the findings obtained from pelvic PNF exercises will serve to fill this gap in the literature.
The hypothesis is that pelvic PNF applications will be superior to lower extremity strengthening exercises in the development of muscle strength, balance and gait in patients with MS who receive 6-week training.
- Conditions
- Multiple Sclerosis
- Being tested
- Pelvic Pnf exercises, Strength exercises
- Keywords
- PNF, Pelvic exercise, strength
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Pnf exercisesOther
Exercise Frequency 3 days/week Exercise Intensity 60% of 1 maximum repetition Exercise Duration: 5-minute warm-up 20 minutes (2 sets of 15 repetitions) exercise training 5 min cool down Exercise Type Pelvic patterns
- Anterior elevation-Posterior depression
- Anterior depression-Posterior elevation PNF techniques
- Repetitive stretching
- Rhythmic stabilization
Strength exercisesOther
3 days/week 60% of 1 repetition maximum 5 minute warm up 20 min exercise training 5 min cool down Lower extremity movements
- Hip flexion
- Hip extension
- Hip abduction
- Hip adduction
- Knee flexion
- Knee extension Resistance exercise training
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | strength exercise training Receives: Other: Strength exercises |
| Study Group | Experimental | pnf exercise training Receives: Other: Pelvic Pnf exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength:
Lower extremity muscle strength will be measured with a digital muscle dynamometer. Lower extremity muscles will be evaluated using a digital dynamometer (Knect). With this device, muscle force values are expressed in Newton (N). Muscle strength will be recorded by making 3 measurements with a digital dynamometer, on the right and left extremities, without allowing the patients to compensate, and the average values will be used.
Measured: Baseline and after 6 weeks
Figure of 8 walk test
It is a standard clinical measurement used to evaluate advanced walking performance required in daily life. In the figure-8 walking test, two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the beginning of the test, the child walks around the first cone as fast as he can, then when he reaches the other starting point, this time he walks around the other cone. The elapsed time is recorded. The validity and reliability of the figure-8 walking test was studied in stroke patients and knee prosthesis patients.
Measured: Baseline and after 6 weeks
12 ıtem walk test
It is a 12-item questionnaire that questions the impact of walking on MS. The difficulties experienced by individuals during walking activity in the last 2 weeks are questioned. Each item contains 5 points (1; not at all impressed, 5; completely impressed). Lower scores indicate better gait impairment. It has been reported that the Turkish version of the scale is valid and reliable.
Measured: Baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Jan 2024
- Primary completion1 Mar 2024
- Study completion15 Mar 2024
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekiye İpek KATIRCI KIRMACI, Kahramanmaras Sutcu Imam University
- Investigators
- Zekiye İpek Katırcı Kırmacı, Principal investigator, Gaziantep Islam Science and Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198972
- Sponsor's protocol ID
- ZİKKKSU
- Status last verified
- Apr 2025
- First submitted
- 27 Dec 2023
- Last updated
- 17 Apr 2025
- 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 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Proprioceptive Neuromuscular Facilitation (PNF) Exercises on Strength, Balance and Walking Skills in Multiple Sclerosis Patients.
- ClinicalTrials.gov ID
- NCT06198972
- Acronym / sponsor ID
- ZİKKKSU
- Conditions
- Multiple Sclerosis
- Keywords
- PNF, Pelvic exercise, strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 10 Jan 2024 (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, demyelinating disease that progresses with motor and sensory loss of the central nervous system and causes disability at different levels. Although signs and symptoms vary depending on the location of the lesion, findings such as loss of muscle strength, spasticity, sensory disorders and fatigue cause decreases in walking function in the majority of patients. Loss of muscle strength and fatigue cause loss of mobility, causing individuals with MS to be less physically active than healthy adults in the same age group. As a result, approximately 40% of individuals with MS have walking problems and approximately 70% of them experience a decrease in daily living activities. Literature studies frequently include strengthening exercises for lower extremity muscles in MS patients. However, the results of pelvic pattern exercises, which are the key to lower extremity movements, are not specified. In this study, which is planned in the light of this information, the findings obtained from pelvic PNF exercises will serve to fill this gap in the literature.
Detailed description
According to the data of the Turkish Neurology Association, it is estimated that there are approximately 40,000 MS patients in Turkey. The fact that it is the most common neurological disease in young adults further increases the importance of the need for effective treatment programs.
Exercise training, which aims to improve the functional losses caused by the disease, constitutes a very important part of rehabilitation protocols. For example, while the effects of resistant exercise training have been investigated in athletes and healthy individuals, no definitive results have been obtained regarding correct and effective exercise approaches in MS.
The basic principle of proprioceptive neuromuscular facilitation techniques, defined as facilitating the responses of the neuromuscular mechanism by stimulating the proprioceptors and briefly expressed as PNF, is based on the principle that physiological movements in the human body have rotational and oblique characters and that a greater response can be achieved with movements performed against maximum resistance.
It consists of the pelvis, sacrum, innominate bones (ilium, ischium, pubis) and coccyx. The vertebral column is directly connected to the lower extremities through the sacroiliac joint and is a weight-bearing structure. Pelvic patterns are in harmony with lower extremity patterns. Because the pelvis actually consists of different functional structures and is in relationship with the lower extremities through the hip joint. Pelvic movements and stability are necessary for adequate function of both the trunk and lower extremities. The therapeutic purposes of pelvic patterns are as follows;
- Pelvic movements and stabilization,
- Body stabilization and movements,
- Rotation etc. functional activities,
- To improve lower extremity movements and stabilization Studies conducted on multiple sclerosis patients indicate that walking patterns differ compared to healthy individuals of the same age. Therefore, the main aim of MS rehabilitation is to maintain walking ability and ensure mobility. To this end; Muscle strength, especially proximal muscles, needs to be increased. Also MS; It is a neurological disease that affects the structures responsible for maintaining balance, such as muscle strength and tone, sensory perception, vision and cognition. For this reason, it is reported that balance and gait control are impaired in approximately 80% of MS patients, increasing the number of falls of patients. Because MS disease involves many areas such as the cerebral hemisphere, brainstem and spinal cord, the cause of balance loss may vary from patient to patient. Balance; It is a response formed jointly by visual, sensory, vestibular systems and motor responses. It is complex because of the way systems work together. There is no definitive evidence as to which system is more effective. However, studies have shown that there is a relationship between loss of muscle strength and decreased walking speed and balance problems. It is stated that lower extremity muscle strength is effective on balance because it supports mobility the most and also plays a fundamental role in sensoriomotor functions.
Literature studies frequently include strengthening exercises for lower extremity muscles in MS patients. However, the results of pelvic pattern exercises, which are the key to lower extremity movements, are not specified. In this study, which we planned in the light of this information, the findings obtained from pelvic PNF exercises will serve to fill this gap in the literature.
The hypothesis is that pelvic PNF applications will be superior to lower extremity strengthening exercises in the development of muscle strength, balance and gait in patients with MS who receive 6-week training.
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 | Active comparator | Other: Strength exercisesstrength exercise training |
| Study Group | Experimental | Other: Pelvic Pnf exercisespnf exercise training |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Consent for the study was obtained;
- Between 18-50 years of age,
- Extended Disability Status Scale (EDSS) score of 4 and below,
- Not in the habit of exercising regularly
- Can walk on the treadmill,
Key exclusion criteria (1 listed)
- Individuals who cannot tolerate the treatment programs and cannot ensure their continuity (2 weeks in a row) will be excluded from the study.
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 |
|---|---|---|
| Pelvic Pnf exercisesExercise Frequency 3 days/week Exercise Intensity 60% of 1 maximum repetition Exercise Duration: 5-minute warm-up 20 minutes (2 sets of 15 repetitions) exercise training 5 min cool down Exercise Type Pelvic patterns * Anterior elevation-Posterior depression * Anterior depression-Posterior elevation PNF techniques * Repetitive stretching * Rhythmic stabilization | Other | Study Group |
| Strength exercises3 days/week 60% of 1 repetition maximum 5 minute warm up 20 min exercise training 5 min cool down Lower extremity movements * Hip flexion * Hip extension * Hip abduction * Hip adduction * Knee flexion * Knee extension Resistance exercise training | Other | Control Group |
Primary outcome
Muscle Strength:
Time frame: Baseline and after 6 weeks
Lower extremity muscle strength will be measured with a digital muscle dynamometer. Lower extremity muscles will be evaluated using a digital dynamometer (Knect). With this device, muscle force values are expressed in Newton (N). Muscle strength will be recorded by making 3 measurements with a digital dynamometer, on the right and left extremities, without allowing the patients to compensate, and the average values will be used.
Figure of 8 walk test
Time frame: Baseline and after 6 weeks
It is a standard clinical measurement used to evaluate advanced walking performance required in daily life. In the figure-8 walking test, two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the beginning of the test, the child walks around the first cone as fast as he can, then when he reaches the other starting point, this time he walks around the other cone. The elapsed time is recorded. The validity and reliability of the figure-8 walking test was studied in stroke patients and knee prosthesis patients.
12 ıtem walk test
Time frame: Baseline and after 6 weeks
It is a 12-item questionnaire that questions the impact of walking on MS. The difficulties experienced by individuals during walking activity in the last 2 weeks are questioned. Each item contains 5 points (1; not at all impressed, 5; completely impressed). Lower scores indicate better gait impairment. It has been reported that the Turkish version of the scale is valid and reliable.
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 17 Apr 2025.
- 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.
Zekiye İpek Katırcı Kırmacı principal investigator
Gaziantep Islam Science and Technology 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 Pelvic Pnf exercises and Strength exercises in people with Multiple Sclerosis, run by Kahramanmaras Sutcu Imam 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 9 inclusion and 1 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 17 Apr 2025. 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?
Muscle Strength: (time frame: Baseline and after 6 weeks). The study lists 3 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 17 Apr 2025.