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Clinical Trials/NCT03945006
NCT03945006
Completed
Not Applicable

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

Ankara Yildirim Beyazıt University1 site in 1 country36 target enrollmentMarch 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Ankara Yildirim Beyazıt University
Enrollment
36
Locations
1
Primary Endpoint
Assessment of the Severity of Incontinence
Status
Completed
Last Updated
6 years ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
March 25, 2019
End Date
April 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ankara Yildirim Beyazıt University
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

  • Trunk Impairment Assesment(3 week)
  • Static Balance Assessment(3 week)
  • Fear of Falling(3 week)

Study Sites (1)

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