Clinical trial NCT05299827: Examination of Trunk and Lower Extremity Biomechanics in Children With LUTD.
Official title: Examination of Trunk and Lower Extremity Biomechanics in Children With Lower Urinary System Dysfunction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Posture Disorders in Children
Muscle Weakness Condition
Urinary Incontinence in Children
Lower Extremity Problem
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Tugtepe Pediatric Urology Clinic
First posted: 2022-03-29
Enrollment: 86
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants aged 5-18 years who were newly diagnosed with lower urinary tract dysfunction and healthy participants in the same age group.

Brief summary: This study aimed to examine trunk and lower extremity biomechanics among children with lower urinary tract dysfunction (LUTD). It was targeted to pioneer including biomechanical changes into treatment if detected in the trunk and lower extremities of children. Voluntary participants meeting inclusion criteria were divided into two groups: the LUTD group (n=43) and the healthy group (n=43). No treatment was applied to participants and the same evaluation methods were used in both groups. Trunk muscle strength, muscle endurance, posture, flexibility, and pelvic floor muscle activity of participants was evaluated with stabilizer pressurized biofeedback unit, sit-ups and modified push-ups test; trunk flexors endurance test and Modified Biering Sorensen Test; Posture Screen Mobile And Foot Posture Index; sit-reach-test and Beighton Score; and NeuroTrac-Myoplus4Pro, respectively. In addition, the quality of life of participants was evaluated with Pediatric Quality of Life Inventory (PedsQL).

Detailed description: A detailed evaluation is of great importance in the correct diagnosis and treatment of patients with LUTD. In order for a holistic evaluation to show the right path, history taking and physical examination are the most important steps of the evaluation. In addition, it is recommended by ICCS to observe and question the conditions that may cause urgency, holding maneuvers and behavioral structure of the patient. In current clinical practice, changes in posture and balance have been noticed during physiotherapy assessments in children and adolescents with incontinence. In addition, we think that it is possible to disrupt the trunk and lower extremity alignments, which are frequently performed by children with incontinence. These changes may be an important part of the physical and developmental disturbances in children with incontinence. The pelvis and lower extremity consist of interconnected closed chain structures. The movement of any link in the chain depends on the movement and positions of the other links. Therefore, disruption of the alignment of one of the links forming and affecting the chain may cause a change in the mobility and stability of all mechanically related structures, and may also affect the optimal force and activation that the pelvic floor muscles can produce. Our study hypothesizes that the movement of any link in the closed chain of the body and the disruption of one of the links forming this chain cause a change in the mobility, stability and balance of all structures that are mechanically connected, this change will closely affect the activation of the pelvic floor muscles, as well as the children in this group. It was stated that the trunk and lower extremity alignment might have been impaired due to the holding maneuvers that he frequently performed.

Our study, it was aimed to examine the trunk and lower extremity biomechanics in children with LUTD. In addition, if biomechanical changes are detected in the trunk and lower extremities of children and adolescents with incontinence, our study will lead to the necessity of including these changes in the treatment.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria of the study group (individuals diagnosed with LUTD):

* The cases are between the ages of 5-17
* Having recently been diagnosed with LUTD by a pediatric urologist according to the criteria set by the ICCS
* Not having a diagnosis of enuresis (bedwetting at night) according to the criteria set by ICCS
* Have not received pelvic floor physiotherapy in the last 6 months

Inclusion criteria of the control group (Healthy individuals):

* To be between the ages of 5-17
* Healthy children without LUTD diagnosis and complaints

Exclusion Criteria:

* Having been diagnosed with primary nocturnal enuresis
* Having been diagnosed with neurogenic lower urinary tract dysfunction
* Existence of any condition (cognitive impairment, mental retardation, etc.) that will prevent the parent and child from answering the questions and completing the self-report scales
* Having an orthopedic disease that would prevent evaluation or undergoing surgery that would affect trunk and lower extremity biomechanics
* Presence of anatomical changes and malformations in the urinary system

Primary outcomes:
measure: Evaluation of Deep Trunk Muscle Strength
timeFrame: Baseline
measure: Sit-ups Test
timeFrame: Baseline
measure: Modified Push-ups Test
timeFrame: Baseline
measure: Trunk Flexors Endurance Test
timeFrame: Baseline
measure: Modified "Biering-Sorensen" Test
timeFrame: Baseline
measure: Posture Assessment
timeFrame: Baseline
measure: Foot Posture Index (FPI-6)
timeFrame: Baseline
measure: Sit and Reach Test
timeFrame: Baseline
measure: Beighton Score
timeFrame: Baseline
Secondary outcomes:
measure: Dysfunctional Voiding and Incontinence Scoring System
timeFrame: Baseline
measure: Childhood Bladder and Bowel Dysfunction Questionnaire (CBDDQ)
timeFrame: Baseline
measure: Pelvic Floor Muscle Activation Measurement
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Tugtepe Pediatric Urology Center
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ebru Kaya Mutlu, Assoc. Prof.
role: STUDY_CHAIR
References: