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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03945006

Recruitment Status Completed

First Posted May 10, 2019

Last update posted May 10, 2019

Study Description

Brief summary:

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.

  • Condition or Disease:Multiple Sclerosis
    Physical Therapy
    Incontinence
  • Intervention/Treatment: Other: Incontinence Severity
    Other: Balance
    Other: Trunk impairment
    Other: Fear of falling
  • Phase: N/A
Detailed Description

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).

Study Design
  • Study Type: Observational
  • Actual Enrollment: 36 participants
  • Observational Model: Case-Control
  • Time Perspective: Prospective
  • Official Title: An Investigation of Balance, Trunk Impairment, and Fear of Falling in Multiple Sclerosis Patients With Incontinence
  • Actual Study Start Date: March 2019
  • Actual Primary Completion Date: April 2019
  • Actual Study Completion Date: April 2019
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Multiple Sclerosis Patients with Incontinence
Multiple Sclerosis with incontinence 24-58 years of age and being volunteered.
Other: Incontinence Severity
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: Balance
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: Trunk impairment
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: Fear of falling
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)
: Multiple Sclerosis Patients without incontinence
Multiple Sclerosis without incontinence 24-58 years of age and being volunteered.
Other: Incontinence Severity
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: Balance
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: Trunk impairment
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: Fear of falling
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)
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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).
Eligibility Criteria
  • Ages Eligible for Study: 24 to 58 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: multiple sclerosis with incontinence and multiple sclerosis without incontinence
Criteria

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

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

Ankara Yildirim Beyazıt University

More Information
  • Responsible Party: Ankara Yildirim Beyazıt University
  • ClinicalTrials.gov Identifier: NCT03945006 History of Changes
  • Other Study ID Numbers: 72
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: May 10, 2019
  • Last Verified: March 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Ankara Yildirim Beyazıt University: Multiple Sclerosis
    Balance
    Trunk impairment
    Fear of falling
    Incontinence
  • Additional relevant MeSH terms: Multiple Sclerosis Sclerosis