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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06198972
Study groupRoleWhat they receive
Control GroupActive comparatorstrength exercise training
Receives: Other: Strength exercises
Study GroupExperimentalpnf exercise training
Receives: Other: Pelvic Pnf exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. 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.

  1. First posted10 Jan 2024
  2. Study start1 Jan 2024
  3. Primary completion1 Mar 2024
  4. Study completion15 Mar 2024

Resources

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)
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

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.

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