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IRCT20140811018760N7 IRCT 2021-04-15 Tabriz University of Medical Sciences The effect of pelvic floor physiotherapy in children with fecal incontinence after surgery for anorectal malformation The effect of pelvic floor physiotherapy in children with fecal incontinence after surgery for anorectal malformation 2021-05-22 anticipated 30 Complete https://irct.ir/trial/55295 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be randomly divided into two groups of 15 participants in the intervention and control groups using a random blocking method with block sizes of 4 and 6 and allocation ratio of 1:1. The output will be A or B that each one is representative of one of the groups. To conceal the allocation, the intervention type will be written on a sheet of paper and placed in a opaque envelope with order number on them. ŮŽ Envelopes will be opened in the order as soon as a participant join the study, so the type of group will identified, Blinding description: This will be a single-blind study, according to the process of interventions, the therapist and the patient can not be blind to the interventions,only the data assessor will be blind to the study groups. The allocation process to the groups will be concealed. N/A Fecal incontinence. Intervention 1: Intervention group: Pelvic floor physiotherapy consists of once a week progressive pelvic floor exercises, biofeedback and electrical stimulation at pelvic floor physiotherapy clinic for 12 weeks. Each session will take 40-50 minutes. Exercises will continued every day at home. Intervention 2: Control group: A routine care consists of laxatives and controlling diet and advising to be physically active. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The data will be made available to the ethics committee or reviewers.
public Fariba Ghaderi
Faculty of Rehabilitation, Daneshgah St., Tabriz
Tabriz Iran (Islamic Republic of) 5167631444 +98 41 3334 5121 ghaderif@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Fariba Ghaderi
Faculty of Rehabilitation, Daneshgah St., Tabriz
Tabriz Iran (Islamic Republic of) 5167631444 +98 41 3334 5121 ghaderif@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Children with fecal incontinence after surgery for anorectal malformation include recto-perinatal fistula and closed anus without fistula Preschool age (4 to 6 years) undergo corrective anorectoplasty surgery in three stages before 6 months of age (colostomy at birth and anorectoplasty and then colostomy closure). Both sexes 4 years 6 years Both Children with associated anomalies such as myelomeningocele, congenital hip dislocation, multiple anomalies Children with learning disabilities R15 Fecal incontinence Treatment - Other Treatment - Other Intervention group: Pelvic floor physiotherapy consists of once a week progressive pelvic floor exercises, biofeedback and electrical stimulation at pelvic floor physiotherapy clinic for 12 weeks. Each session will take 40-50 minutes. Exercises will continued every day at home. Control group: A routine care consists of laxatives and controlling diet and advising to be physically active Severity of fecal incontinence. Timepoint: At the beginning of the study (before the intervention) and at the end of the intervention. Method of measurement: Rintala Questionnaire. Severity of constipation. Timepoint: At the beginning of the study (before the intervention) and at the end of the intervention. Method of measurement: Pediatric constipation score Questionnaire. Pelvic floor muscles strength. Timepoint: At the beginning of the study (before the intervention) and at the end of the intervention. Method of measurement: The strength of pelvic floor muscles will be determined by rectal digital examination and oxford scale. Tabriz University of Medical Sciences Approved 2021-01-11 Ethics Committee of Tabriz University of Medical Sciences Faculty of Rehabilitation, Daneshgah St., Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)