Examination of Trunk and Lower Extremity Biomechanics in Children With LUTD.

NCT05299827 | Completed

• 1 other identifier: IUC-001
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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).

Conditions

Lower Urinary Tract Symptoms; Posture Disorders in Children; Muscle Weakness Condition; Urinary Incontinence in Children; Lower Extremity Problem

Outcome Measures

Primary Outcomes (9)

• Evaluation of Deep Trunk Muscle Strength

  The measurement of the contraction force of the transversus abdominis from the deep trunk muscles was performed with the Stabilizer Pressure Biofeedback Unit (Chattanooga Stabilizer, USA).Participants were placed in the prone position on a triple inflated object attached to a manometer. Participants were instructed to lie down with the knees straight, spine straight, and head in a comfortable position by placing the inflated object in the lower part of the abdominal region with its long lower edge parallel to the crista iliacas. After the pressure of the manometer was adjusted to 70 mmHg, the participants were asked to slowly contract the transversus abdominis muscle with the abdominal corset technique and maintain this contraction for 5 seconds without holding their breath. Three measurements were recorded and averaged.

  Baseline

• Sit-ups Test

  With the knees in the flexed position and the feet stabilized, the participants were asked to flex the trunk. During the evaluation, it was recorded how many times the participants were able to perform the movement for 30 seconds.

  Baseline

• Modified Push-ups Test

  The subjects were positioned prone, knees on the floor, legs flexed, trunk on the floor, elbows flexed, and trunk on the side. From this position, they were asked to raise the head, shoulders and trunk from the ground with the elbows fully extended. During the evaluation, it was recorded how many times the participants were able to do it for 30 seconds.

  Baseline

• Trunk Flexors Endurance Test

  The participants took positions with the trunk flexed to 60º, knees and hips to 90º flexion. The test was terminated as soon as 60° of trunk flexion was impaired. The time that the participant held this position was recorded in seconds.

  Baseline

• Modified "Biering-Sorensen" Test

  With this test, the endurance of trunk extensors was evaluated. Participants were positioned in the prone position with the pelvis, hips and knees in full contact with the treatment bed. The participants' pelvis was supported with a belt and fixed by the physiotherapist. The participants were asked to extend their upper body straight forward from the edge of the table, extend it and stay in this position. The time he was able to hold this position properly was recorded in seconds.

  Baseline

• Posture Assessment

  The postures of the participants were evaluated with the ''Posture Screen Mobile Application''. Front and side photos of the participants were taken with an iOS software phone positioned on a tripod. On the software, the original points determined in the application were marked using the touch screen. According to the reference points, the postural disorder values and the degree of the disorder were calculated for each patient in "cm" via the software and reported. Angular values were expressed as "degrees" (⁰), and distance and offset distances were expressed as "cm". The photographs taken for analysis were digitized using the "Posture Screen" mobile application and the analysis was done through the application.

  Baseline

• Foot Posture Index (FPI-6)

  For posture analysis of the foot, evaluation was made while the participant was standing and in a relaxed position. Within the scope of FPI-6, bulging in the talonavicular joint area, the structure of the medial longitudinal arch and abduction or adduction of the forefoot with respect to the hindfoot, palpation of the talus head, inclination above and below the lateral malleolus, pronation/supination position of the calcaneus were evaluated. 0 points for neutral foot, positive points for pronation. , a negative score indicates supination. Total scores for left and right feet were recorded separately.

  Baseline

• Sit and Reach Test

  In order to determine flexibility, the participants were asked to sit on the floor, stretch their legs and rest their soles on a 32 cm high and 35 cm long coffee table without shoes. They were asked to reach forward as far as they could on the coffee table without bending their waist, hips and knees. Participants lie down with their right knee bent, left knee bent, and both knees fully lying on the floor. The distance between the fingers of the distal tip of the middle finger of the hand and the tip of the test table was measured and recorded as cm.

  Baseline

• Beighton Score

  It is evaluated out of nine points. It is generally accepted that a score of four or more out of nine points indicates hypermobility. In our study, the first four items were evaluated symmetrically in all extremities, as suggested in the scale. Evaluations were made by the participants separately for the movements for the right and left extremities, and 1 point will be given separately for each movement that can be performed on the right-left side. The fifth item includes the whole body. It is the palm touching the ground while standing and knees extended. When this desired movement was performed, it was evaluated as 1 point.

  Baseline

Secondary Outcomes (3)

• Dysfunctional Voiding and Incontinence Scoring System

  Baseline

• Childhood Bladder and Bowel Dysfunction Questionnaire (CBDDQ)

  Baseline

• Pelvic Floor Muscle Activation Measurement

  Baseline

Study Arms (2)

Children diagnosed with lower urinary system dysfunction (LUTD Group)

Children who are between the ages of 5-18 and diagnosed with lower urinary system dysfunction by pediatric urologist.

Other: The same evaluation methods were used for both groups.

Healty Group

Healthy participants in the same age group in the control group; The siblings or cousins of the cases who applied to Tuğtepe Pediatric Urology Center but did not meet the inclusion and exclusion criteria and/or the cases who applied to the outpatient clinic were determined to be healthy after being examined by the relevant physician, and consisted of girls and boys who volunteered to participate in the study. .

Other: The same evaluation methods were used for both groups.

Interventions

The same evaluation methods were used for both groups. OTHER

No treatment applied to participants and same evaluation methods 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,

Children diagnosed with lower urinary system dysfunction (LUTD Group); Healty Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Tugtepe Pediatric Urology Clinic: collaborator

Study Sites (1)

Tugtepe Pediatric Urology Center

Istanbul, 34750, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ebru Kaya Mutlu, Assoc. Prof.

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: March 29, 2022
• Study Start: March 4, 2021
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

TU (1)