Whole Body Vibration Training in the Treatment for Children's Incontinence - a Randomized-Controlled Trial

NCT ID: NCT04737447

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2023-01-31

Brief Summary

The determined study category is a prospective clinical randomized controlled study to evaluate the effect of WBVT in combination with urophysiotherapy to playfully expand the therapeutic options for children and adolescents with incontinence. This will be the first time use of WBVT for treating incontinence in children.

Detailed Description

Approximately up to 20% of children suffer from urinary incontinence. These children and frequently their families are emotionally and behaviourally affected which in turn leads to psychological distress. Urophysiotherapy became one of the first line treatments for children with urinary incontinence. Urophysiotherapy includes pelvic floor muscles training (PFMT), a treatment method not easily applicable in children. We therefore supplement the standard training with WBVT which is already evaluated in the adult population to improve the strength of the muscles of the pelvic floor. With the medical device of Galileo® children are able to train the pelvic muscles automatically and playfully.The primary objective is to investigate the effect of WBVT on children's incontinence measured by validated incontinence scores (DVISS, RUIS). The secondary objective is to evaluate the effect on the bladder function (uroflowmetry, residual urine).The primary outcome is to significantly improve incontinence symptoms by using WBVT in combination with urophysiotherapy for 9 weeks measured by incontinence scores.I nclusion criteria

• Male and Female participants 7-16 years of age
• Daytime incontinence (> 6 months)
• Written informed consent by the participant after information about the research project Exclusion criteria
• Neurogenic bladder dysfunction
• Congenital anomalies of the urinary tract
• Patients who already take part in another study concerning treating incontinence 30 days before and after participation in this study
• Patients with incontinence, who already underwent urophysiotherapy
• Medication for treating incontinence

• Contraindications for the use of Galileo®: epilepsy, acute fractures, urolithiasis, cholecystolithaisis, after recent surgery, acute hernia, arthritis, thrombosis, rheumatic diseases, acute discopathy, patients with implants diabetes or pregnancy.
• Patients and parents without any motivation for urophysiotherapy
• Patients who neither mentally nor physically are able to pursue urophysiotherapy

In this randomized controlled trial children with incontinence will be randomly assigned in two groups: an "urophysiotherapy plus WBVT" group and a control group receiving urophysiotherapy only. The children will be treated in both groups according to a standardized protocol for 9 weeks. In addition to clinical investigations and urodynamic studies two different incontinence scores (DVISS and RUIS) will be used to determine the severity of incontinence at the time of diagnosis, at the end of the therapy (12 weeks after assessment), 24 and at 48 weeks after assessment. To determine the effect of WBVT the results will be compared using the Student's t-test and the Mann-Whitney U test.

Conditions

Incontinence, Urinary

Keywords

Whole Body Vibration Training (WBVT); Incontinence in children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (Control Group)

20 participants treated with standardized urophysiotherapy twice a week, once for 45 Minutes and then for 15 Minutes. Urophysiotherapy is a well manifested and standardized therapy in the treatment für children's incontinence after the age of five years.

Group Type: ACTIVE_COMPARATOR

Whole Body Vibration Training

Intervention Type: DEVICE

Galileo® Trainer is a vibration board. The movement alternating to different sides during walking correlates with the movement on the board due to variable amplitudes and frequencies. Movements of the vibration board are quickly changing and thus simulating the tilting movements of the pelvic during walking but with higher frequency. Muscles of legs and core are activated reflexively. In our study there are performed static practices and pelvic activating practices. Each physiotherapist is experienced in the technical and practical handling of the device.

Group B (Study Group)

20 participants treated with standardized urophysiotherapy and Whole Body Vibration training (WBVT). These patients are treated with the standardized urophysiotherapy once a week and furthermore they train with WBVT twice a week for each time 15 minutes. Criteria for modifying the device utilization are based on participant's age and therapy progress. The utilized frequency of the device is individually adapted to the participant. Older patients (\> ten years old) are allowed to higher frequency standards than younger participants (\< 10 years old). The amplitude (0.5 mm - 2 mm) is alternated to the participant's age and height. If side effects occur (e.g. dizziness), frequency can be alternated. The intended frequency level is between 10 an 20 Hz.

Group Type: ACTIVE_COMPARATOR

Whole Body Vibration Training

Intervention Type: DEVICE

Galileo® Trainer is a vibration board. The movement alternating to different sides during walking correlates with the movement on the board due to variable amplitudes and frequencies. Movements of the vibration board are quickly changing and thus simulating the tilting movements of the pelvic during walking but with higher frequency. Muscles of legs and core are activated reflexively. In our study there are performed static practices and pelvic activating practices. Each physiotherapist is experienced in the technical and practical handling of the device.

Interventions

Whole Body Vibration Training

Galileo® Trainer is a vibration board. The movement alternating to different sides during walking correlates with the movement on the board due to variable amplitudes and frequencies. Movements of the vibration board are quickly changing and thus simulating the tilting movements of the pelvic during walking but with higher frequency. Muscles of legs and core are activated reflexively. In our study there are performed static practices and pelvic activating practices. Each physiotherapist is experienced in the technical and practical handling of the device.

Intervention Type: DEVICE

Other Intervention Names

Galileo Training

Eligibility Criteria

Inclusion Criteria

• Male and Female participants 7-16 years of age
• Daytime incontinence (> 6 months)
• Written informed consent by the participant after information about the research project

Exclusion Criteria

• Neurogenic bladder dysfunction
• Congenital anomalies of the urinary tract
• Patients who already take part in another study concerning treating incontinence 30 days before and after participation in this study
• Patients with incontinence, who already underwent urophysiotherapy
• Medication for treating incontinence
• Contraindications for the use of Galileo®: epilepsy, acute fractures, urolithiasis, cholecystolithaisis, after recent surgery, acute hernia, arthritis, thrombosis, rheumatic diseases, acute discopathy, patients with implants diabetes or pregnancy.
• Patients and parents without any motivation for urophysiotherapy
• Patients who neither

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Children's Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Alice Hoelscher

Dr. med. Alice Catherine Hoelscher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hoelscher

Role: PRINCIPAL_INVESTIGATOR

Consultant in Pediatric Urology

Locations

University Children's Hospital

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

10642

Identifier Type: -

Identifier Source: org_study_id