Clinical trial NCT03945006: Balance, Trunk Impairment and Fear of Falling in Multiple Sclerosis Patients With Incontinence
Official title: An Investigation of Balance, Trunk Impairment, and Fear of Falling in Multiple Sclerosis Patients With Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Physical Therapy
Incontinence
Keywords: Multiple Sclerosis
Balance
Trunk impairment
Fear of falling
Incontinence
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 36
Sex: ALL
Minimum age (years): 24
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: multiple sclerosis with incontinence and multiple sclerosis without incontinence

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).

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

Primary outcomes:
measure: Assessment of the Severity of Incontinence
timeFrame: 3 week
Secondary outcomes:
measure: Static Balance Assessment
timeFrame: 3 week
measure: Trunk Impairment Assesment
timeFrame: 3 week
measure: Fear of Falling
timeFrame: 3 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
state: Esenboğa
Study officials:
References: