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

NCT03945006 | Completed

• 1 other identifier: 72
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Physical Therapy; Incontinence

Keywords

Multiple Sclerosis; Balance; Trunk impairment; Fear of falling; Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Static Balance Assessment

  3 week

• Trunk Impairment Assesment

  3 week

• Fear of Falling

  3 week

Study Arms (2)

Multiple Sclerosis Patients with Incontinence

Multiple Sclerosis with incontinence 24-58 years of age and being volunteered.

Other: Incontinence Severity; Other: Balance; Other: Trunk impairment; Other: Fear of falling

Multiple Sclerosis Patients without incontinence

Multiple Sclerosis without incontinence 24-58 years of age and being volunteered.

Other: Incontinence Severity; Other: Balance; Other: Trunk impairment; Other: Fear of falling

Interventions

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.

Also known as: Evaluation

Multiple Sclerosis Patients with Incontinence; Multiple Sclerosis Patients without incontinence

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.

Also known as: Evaluation

Multiple Sclerosis Patients with Incontinence; Multiple Sclerosis Patients without incontinence

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.

Also known as: Evaluation

Multiple Sclerosis Patients with Incontinence; Multiple Sclerosis Patients without incontinence

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)

Also known as: Evaluation

Multiple Sclerosis Patients with Incontinence; Multiple Sclerosis Patients without incontinence

Eligibility Criteria

• Age: 24 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

multiple sclerosis with incontinence and multiple sclerosis without incontinence

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

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

Ankara, Esenboğa, 06970, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: March 25, 2019
• Primary Completion: April 20, 2019
• Study Completion: April 30, 2019
• Last Updated: May 10, 2019

Record last verified: 2019-03

Locations

TU (1)