Wii Fit Game Based Abdomino-Pelvic Training In Urinary Incontinence
Primary Purpose
Incontinence, Urinary
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Wii Fit Training Experimental Group
Conventional Training
Sponsored by
About this trial
This is an interventional other trial for Incontinence, Urinary focused on measuring Wii Fit, Urinary Incontinence, Females, Abdomino-Pelvic Training
Eligibility 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.
Sites / Locations
- Riphah International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Wii Fit Training Experimental Group
Conventional Training Control Group
Arm Description
receiving Wii fit based abdomino-pelvic training
receiving conventional pelvic floor exercises.
Outcomes
Primary Outcome Measures
EMG biofeedback
EMG biofeedback device shows electrical activity of pelvic floor muscles and can assist with both muscle strengthening AND relaxation training
Secondary Outcome Measures
Michigan Incontinence Symptoms Index:
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
Full Information
NCT ID
NCT03727269
First Posted
October 24, 2018
Last Updated
August 7, 2019
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT03727269
Brief Title
Wii Fit Game Based Abdomino-Pelvic Training In Urinary Incontinence
Official Title
Role Of Wii Fit Game Based Abdomino-Pelvic Training In Females With Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
February 15, 2019 (Actual)
Study Completion Date
February 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence, Urinary
Keywords
Wii Fit, Urinary Incontinence, Females, Abdomino-Pelvic Training
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wii Fit Training Experimental Group
Arm Type
Experimental
Arm Description
receiving Wii fit based abdomino-pelvic training
Arm Title
Conventional Training Control Group
Arm Type
Active Comparator
Arm Description
receiving conventional pelvic floor exercises.
Intervention Type
Other
Intervention Name(s)
Wii Fit Training Experimental Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Training
Intervention Description
Control group (n=20) receiving conventional pelvic floor exercises. Conventional exercises includes:
Knack Maneuver (Ashton -Miller 1998, 2008)
Pelvic floor strengthening: kegel Exercise.
-Lumbo-Pelvic Stabilization Exercise.
Functional Training/ PFM Contraction during ADL
Correction of biomechanical/structural deformities
Primary Outcome Measure Information:
Title
EMG biofeedback
Description
EMG biofeedback device shows electrical activity of pelvic floor muscles and can assist with both muscle strengthening AND relaxation training
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Michigan Incontinence Symptoms Index:
Description
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
Time Frame
8th week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal females
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
imran Amjad
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25225003
Citation
Wood LN, Anger JT. Urinary incontinence in women. BMJ. 2014 Sep 15;349:g4531. doi: 10.1136/bmj.g4531.
Results Reference
background
PubMed Identifier
3115486
Citation
Hilton P. Urinary incontinence in women. Br Med J (Clin Res Ed). 1987 Aug 15;295(6595):426-32. doi: 10.1136/bmj.295.6595.426. No abstract available.
Results Reference
background
PubMed Identifier
23972338
Citation
Osborn DJ, Strain M, Gomelsky A, Rothschild J, Dmochowski R. Obesity and female stress urinary incontinence. Urology. 2013 Oct;82(4):759-63. doi: 10.1016/j.urology.2013.06.020. Epub 2013 Aug 22.
Results Reference
background
PubMed Identifier
1942274
Citation
Burgio KL, Matthews KA, Engel BT. Prevalence, incidence and correlates of urinary incontinence in healthy, middle-aged women. J Urol. 1991 Nov;146(5):1255-9. doi: 10.1016/s0022-5347(17)38063-1.
Results Reference
background
PubMed Identifier
12626910
Citation
Dobson HD, Pearl RK, Orsay CP, Rasmussen M, Evenhouse R, Ai Z, Blew G, Dech F, Edison MI, Silverstein JC, Abcarian H. Virtual reality: new method of teaching anorectal and pelvic floor anatomy. Dis Colon Rectum. 2003 Mar;46(3):349-52. doi: 10.1097/01.DCR.0000054639.29160.9E.
Results Reference
background
PubMed Identifier
27437716
Citation
Martinho NM, Silva VR, Marques J, Carvalho LC, Iunes DH, Botelho S. The effects of training by virtual reality or gym ball on pelvic floor muscle strength in postmenopausal women: a randomized controlled trial. Braz J Phys Ther. 2016 Mar 22;20(3):248-57. doi: 10.1590/bjpt-rbf.2014.0148.
Results Reference
background
PubMed Identifier
25925487
Citation
Botelho S, Martinho NM, Silva VR, Marques J, Carvalho LC, Riccetto C. Virtual reality: a proposal for pelvic floor muscle training. Int Urogynecol J. 2015 Nov;26(11):1709-12. doi: 10.1007/s00192-015-2698-5. Epub 2015 Apr 30.
Results Reference
background
PubMed Identifier
25450755
Citation
Steenstrup B, Giralte F, Bakker E, Grise P. [Evaluation of the electromyography activity of pelvic floor muscle during postural exercises using the Wii Fit Plus(c). Analysis and perspectives in rehabilitation]. Prog Urol. 2014 Dec;24(17):1099-105. doi: 10.1016/j.purol.2014.09.046. Epub 2014 Oct 23. French.
Results Reference
background
PubMed Identifier
24415577
Citation
Elliott V, de Bruin ED, Dumoulin C. Virtual reality rehabilitation as a treatment approach for older women with mixed urinary incontinence: a feasibility study. Neurourol Urodyn. 2015 Mar;34(3):236-43. doi: 10.1002/nau.22553. Epub 2014 Jan 10.
Results Reference
background
PubMed Identifier
28508398
Citation
Bertotto A, Schvartzman R, Uchoa S, Wender MCO. Effect of electromyographic biofeedback as an add-on to pelvic floor muscle exercises on neuromuscular outcomes and quality of life in postmenopausal women with stress urinary incontinence: A randomized controlled trial. Neurourol Urodyn. 2017 Nov;36(8):2142-2147. doi: 10.1002/nau.23258. Epub 2017 May 16.
Results Reference
background
PubMed Identifier
16953917
Citation
Capelini MV, Riccetto CL, Dambros M, Tamanini JT, Herrmann V, Muller V. Pelvic floor exercises with biofeedback for stress urinary incontinence. Int Braz J Urol. 2006 Jul-Aug;32(4):462-8; discussion 469. doi: 10.1590/s1677-55382006000400015.
Results Reference
background
PubMed Identifier
24519688
Citation
Thubert T, Deffieux X, Jousse M, Guinet-Lacoste A, Ismael SS, Amarenco G. Influence of a distraction task on pelvic floor muscle contraction. Neurourol Urodyn. 2015 Feb;34(2):139-43. doi: 10.1002/nau.22524. Epub 2014 Feb 12.
Results Reference
background
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Wii Fit Game Based Abdomino-Pelvic Training In Urinary Incontinence
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