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Wii Fit Game Based Abdomino-Pelvic Training In Urinary Incontinence

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ClinicalTrials.gov Identifier: NCT03727269
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Brief Summary:
This study is aimed to determine the effect of Wii fit based abdomino-pelvic training on strength of pelvic floor muscles and on symptoms of urinary incontinence in females. An experimental, randomized controlled trial will be performed. Both reproductive and postmenopausal females with stress urinary incontinence will be included. 40 participants would be randomly distributed in experimental group (n=20) receiving wii fit based abdomino-pelvic training and control group (n=20) receiving conventional pelvic floor exercises. Pelvic floor strength would be assessed before and after by Digital method and EMG biofeedback. Urinary symptoms would be assessed by bladder diary, pad test and International consultation on Incontinence Questionnaires. Health related Quality of life questionnaire would also be used as an outcome measure. Data will be analyzed on SPSS 21 version using descriptive and inferential statistics

Condition or disease Intervention/treatment Phase
Incontinence, Urinary Other: Wii Fit Training Experimental Group Other: Conventional Training Not Applicable

Detailed Description:

Loss of bladder control results causes the accidental leak of urine is called urinary incontinence. It may be slightly bothersome or totally debilitating. It may leads to embarrassment and keeps them away from enjoying many physical activities, including exercising. Urinary incontinence may develop emotional distress because of some outside factors, such as difficulty getting to standing position or only being able to walk slowly, which prevent them from getting to the toilet on time.

Old women experience urinary incontinence more than young women or young girls. Muscles in the wall of bladder contracts during urination. Sphincter muscles surrounding the urethra relax which let the urine to pass out from the body. Incontinence will occur when the muscles of bladder suddenly contracts or are not strong enough to hold back the urine. Then the urine may escape with less pressure than usual when the muscles are damaged, this causing a change in the position of the bladder.

Stress incontinence is the most common type of urinary incontinence. 80% of the females suffering from urinary incontinence have stress urinary incontinence. Obese women having greater intra-abdominal pressure leads to weakening of pelvic floor muscle which causes stress incontinence.

During pregnancy, child birth and menopause physical changes results in the weakening of muscles of bladder. As the result of physical exertions, muscles of bladder become weak that increase intra-abdominal pressure leakage may cause. Leakage may occur during coughing, sneezing or heavy lifting.

Wii fit games are computer-generated scenario that simulates experience through senses and perception. This approach is being used by physical therapist so than their patient stick to their exercise protocol and it enhance their training and functional level. Wii fit game based pelvic floor muscle exercises helps the pelvic floor muscle to strengthen by different movements such as anteversion,, retroversion, lateral tilting, truck rotation, circumduction and pelvic stabilization. video game based treatment that enhance patients' motivation, functional training and hence adherence to exercise regimen. As clinical practice in women's health physical therapy lacks options for pelvic floor muscle training and wii fit game based pelvic floor rehabilitation is an innovated method so could be a valuable adjunct in management of female urinary incontinence protocol.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental group
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Role Of Wii Fit Game Based Abdomino-Pelvic Training In Females With Urinary Incontinence
Actual Study Start Date : November 15, 2018
Actual Primary Completion Date : February 15, 2019
Actual Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wii Fit Training Experimental Group
receiving Wii fit based abdomino-pelvic training
Other: Wii Fit Training Experimental Group
Experimental group receiving wii fit game based abdomino-pelvic training. A specific protocol was developed by the researchers. Wii fit games which promote exercises focusing on the abdominopelvic cavity strengthening, using as a therapeutic means a Wii™ console with a Wii Fit Plus™ CD game. The protocol was design that which playing games participant perform different pelvic movements such as anteversion, retroversion, lateral tilt and circumduction that maintain trunk control and stabilization with mild abdomino-pelvic muscle activation. Duration of each game is 5 minutes with 90 seconds interval between them twice a week. After performing the sequence of virtual games, a series of abdominopelvic and lower limb muscle stretching exercises will done.

Active Comparator: Conventional Training Control Group
receiving conventional pelvic floor exercises.
Other: Conventional Training

Control group (n=20) receiving conventional pelvic floor exercises. Conventional exercises includes:

  1. Knack Maneuver (Ashton -Miller 1998, 2008)
  2. Pelvic floor strengthening: kegel Exercise.
  3. -Lumbo-Pelvic Stabilization Exercise.
  4. Functional Training/ PFM Contraction during ADL
  5. Correction of biomechanical/structural deformities




Primary Outcome Measures :
  1. EMG biofeedback [ Time Frame: 8 week ]
    EMG biofeedback device shows electrical activity of pelvic floor muscles and can assist with both muscle strengthening AND relaxation training


Secondary Outcome Measures :
  1. Michigan Incontinence Symptoms Index: [ Time Frame: 8th week ]
    Michigan incontinence symptoms index is a clinical measure of type, severity and bother related to urinary incontinence.The M-ISI is a parsimonious measure that has established reliability and validity on several levels and complements current clinical evaluative methods for patients with urinary incontinence



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Postmenopausal females
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • Females with only stress urinary incontinence (SUI).

Exclusion Criteria:

  • Females with urinary tract infection.
  • Females with myopathy, neurological abnormalities, cognitive or physical disorder that could hinder in training and assessment.
  • Pelvic floor muscle strength 0 on Modified oxford grading scale and pelvic organ prolapse greater than or equal to 3 on pelvic organ Quantification (POP-Q) system.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727269


Locations
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Pakistan
Riphah International University
Islamabad, Federal, Pakistan, 44000
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: imran Amjad Riphah International University

Publications:

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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT03727269     History of Changes
Other Study ID Numbers: RiphahIU Mizna Saleh
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Wii Fit
Urinary Incontinence
Females
Abdomino-Pelvic Training
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders