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NCT Number: NCT03945006

Balance, Trunk Impairment and Fear of Falling in Multiple Sclerosis Patients With Incontinence

The aim of the present study was to examine balance, trunk impairment, and fear of falling in MS patients with incontinence. Clinical symptoms of the MS patients are heterogenous, and they vary according to the lesion levels and the duration and the type of the disease. In the neurologic group,especially in MS patients, incontinence is observed even at early stages.

Pelvic floor muscles contribute to continence by stabilizing the bladder neck and increasing the intraurethral pressure. Furthermore, they mechanically support the spine and the pelvis.This mechanical support is attained through an increase in sacroiliac joint stiffness and intra-abdominal pressure changes, which are important for spinal control. Along with incontinence, this mechanical support deteriorates resulting in some problems. By this way, postural function of pelvic floor muscles may alter in individuals with incontinence, and thus, lumbopelvic stabilization may be negatively affected. In addition, the activity of trunk muscles changes in individuals with incontinence, which may result in spinal movement and affect the posture. Therefore, balance disorders may develop. Postural sways caused by balance disorders and the decrease in postural corrections have been listed among risk the factors associated with falling.

When literature is examined, there exists no study examining the effects of incontinence on balance, trunk impairment, and fear of falling in MS patients. For all these reasons, investigators think that incontinence in MS patients has an effect on balance, trunk impairment, and fear of fall.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Incontinence Nervous System Diseases Physical Therapy

Age range

24 year–58 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation

Ankara, Esenboğa, 06970, Turkey (Türkiye)

About this study

This study was aimed to investigate balance, trunk impairment, and fear of falling in MS patients with and without incontinence.

The study was conducted in 35 MS patients with an age range of 24-58 years. The patients were divided into two groups based on the occurrence of incontinence. A neurologic examination was performed using the EDSS by a neurologist.

Incontinence was measured with the Incontinence Severity Index (ISI), balance was measured with a Technobody® stabilometric platform, and fear of falling was measured with the Falls Efficacy Scale (FES).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of Multiple Sclerosis Disease
  • The level of disability should be between 0.5-4 according to EDSS
  • having a score of 24 or more in the Mini Mental Status Test

Exclusion criteria

  • Patients with acute attacks (six months prior to the study)
  • Mini-Mental State Examination (MMSE) score of less tahn 25 points
  • History of shoulder injury, surgery, medical problems or other neurological disorders in any of the participants

Treatment and study plan

Incontinence Severity

Other

The Incontinence Severity Index (ISI) was used to assess the MS patients' incontinence severity.The first item is scored between 1 and 4 and the second item is scored between 1 and 3. The total score is calculated by the multiplication of these two answers. The index score is classified as 1-2 slight, 3-6 moderate, 8-9 severe, and 12 very severe.

Other names: Evaluation

balance

Other

The patients were assessed while their bladders were empty. The static balance of the patients was measured with a Technobody® stabilometric platform. The patients were assessed while their bladders were empty. The test was performed as the patients' arms on the sides, eyes open and closed, and on two feet. Ellipse area, anterior-posterior sway, and medial-lateral sway scores were recorded.

Other names: Evaluation

Trunk impairment

Other

Trunk impairment was assessed with the Trunk Impairment Scale (TIS) while the participants' bladders were empty. The scale evaluates static and dynamic sitting balance and trunk coordination through 17 items. Each item is scored between 0 and 3. The total score ranges between 0 and 23, and higher scores indicate a better balance performance.

Other names: Evaluation

Fear of falling

Other

Fear of falling was assessed using the Falls Efficacy Scale developed by Tinetti and colleagues. The scale has 10 items assessing the effect of fear of falling on the confidence level of the individuals while performing activities of daily living. Each items is scored by the participants between 0 (not at all concerned) and 10 (very concerned), and the total of the score ranges between 0 (low fall efficacy) and 100 (high fall efficacy)

Other names: Evaluation

Primary outcomes

  1. Assessment of the Severity of Incontinence

    Time frame: 3 week

    The Incontinence Severity Index (ISI) was used to assess the MS patients' incontinence severity. The first item is scored between 1 and 4 and the second item is scored between 1 and 3. The total score is calculated by the multiplication of these two answers. The index score is classified as 1-2 slight, 3-6 moderate, 8-9 severe, and 12 very severe.

Secondary outcomes

  1. Static Balance Assessment

    Time frame: 3 week

    The static balance of the patients was measured with a Technobody® stabilometric platform. The test was performed as the patients' arms on the sides, eyes open and closed, and on two feet. Ellipse area, anterior-posterior sway, and medial-lateral sway scores were recorded. As the sway increases, the balance disorder increases.

  2. Trunk Impairment Assesment

    Time frame: 3 week

    Trunk impairment was assessed with the Trunk Impairment Scale. The scale evaluates static and dynamic sitting balance and trunk coordination through 17 items. Each item is scored between 0 and 3. The total score ranges between 0 and 23, and higher scores indicate a better balance performance.

  3. Fear of Falling

    Time frame: 3 week

    Fear of falling was assessed using the Falls Efficacy Scale. The scale has 10 items assessing the effect of fear of falling on the confidence level of the individuals while performing activities of daily living. Each items is scored by the participants between 0 (not at all concerned) and 10 (very concerned), and the total of the score ranges between 0 (low fall efficacy) and 100 (high fall efficacy).

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

An Investigation of Balance, Trunk Impairment, and Fear of Falling in Multiple Sclerosis Patients With Incontinence

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 10, 2019
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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