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

An Investigation of 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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Physical Therapy; Incontinence
• Intervention / Treatment: Other: Incontinence Severity; Other: Balance; Other: Trunk impairment; Other: Fear of falling

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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Turkey
  • Esenboğa
    • Ankara, Esenboğa, Turkey, 06970
      • Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

multiple sclerosis with incontinence and multiple sclerosis without incontinence

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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 Names: Evaluation; 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 Names: Evaluation; 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 Names: Evaluation; 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); Other Names: Evaluation
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 Names: Evaluation; 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 Names: Evaluation; 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 Names: Evaluation; 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); Other Names: Evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the Severity of Incontinence	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.	3 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static Balance Assessment	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.	3 week
Trunk Impairment Assesment	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 week
Fear of Falling	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).	3 week

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Actual): April 20, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Balance; Incontinence; Trunk impairment; Fear of falling
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 72

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No