Analyzing Gait Parameters Among Women With and Without Stress Urinary Incontinence
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age40-60
SponsorCairo University
About this trial
This study will contribute to the existing body of knowledge on stress urinary incontinence and its impact on gait. The findings may have implications for the development of targeted interventions and rehabilitation strategies to improve mobility and quality of life in women with stress urinary incontinence
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 40-60 years old.
Women with BMI ≥30.
Women are free from any other gynecological disorders or symptoms that may affect the results of the study.
All participants who will be enrolled in the study sign the informed consent form.
Disqualifiers
Pregnancy
Neurological Disorders: such as Parkinson's disease , multiple sclerosis, or any neurological dysfunction that may affect the gait parameters
Musculoskeletal disorders: such as severe osteoarthritis or lower limb amputations
Significant cognitive impairment: or dementia
Trial population
One hundred twenty-four female participants who have stress urinary incontinence will participate in this study. Their ages will be ranged from 40 to 60 years. The participants will be selected from Mansoura University Hospitals and randomly distributed into two equal groups in numbers.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Incontinence Symptom Severity Index
Other intervention* The ISSI consists of eight items that assess different aspects of urinary incontinence symptoms, including emptying difficulties, nocturia, daytime frequency, stress incontinence, urge incontinence, leakage with activity, and pad use. * Each item is scored on a scale of (0 to 3) or (0 to 4), depending on the severity of the symptom. Higher scores indicate more severe symptoms. * The total ISSI score is obtained by summing the scores of all eight items, resulting in a range of 0 to 32 or 0 to 40, depending on the version used. * The severity of urinary incontinence symptoms can be categorized based on the total ISSI score
Force platform
Other interventionUse the provided software or tools to analyze the recorded force data, including Step Cycle Duration (ms), Time of Contact (ms), Swing Duration (ms), Single Step Duration (ms), Double Support Duration (ms), Initial Contact (ms) , Loading Response (ms), Mid Stance (ms), Terminal Stance (ms), Step Cycle Length, Half Step Length for left and right lower limbs. * Interpret the data to draw conclusions about the forces exerted during the subject's movements or activities.
The STT three-dimensional motion analysis (3DMA) system
Other interventionThe STT three-dimensional motion analysis (3DMA) system (STT Systems Company, Zuatzu Business Park, Easo Building, 2nd Floor, San Sebastián, Spain) was used for the assessment of spatiotemporal characteristics of gait. It is an indoor optical system that consists of four cameras, fifteen markers, and computer software for automatic three-dimensional motion capture and analysis. CLINICAL 3DMA V.6.11 is professional software with highly accurate marker tracking. The STT Helen Hayes protocol was used for the gait analysis in this study.
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: women with stress urinary incontinence3 interventions
Group B: women without stress urinary incontinence3 interventions
Trial outcomes
Primary outcomes
1
Incontinence Symptom Severity Index
The Incontinence Symptom Severity Index (ISSI) is a self-assessment instrument used to measure the severity of female urinary storage and voiding symptoms.
Time frame
one daySecondary outcomes
1
Force platform
After data collection, the recorded data is analysed to extract various gait parameters. These parameters include: Srtide lengh for left and right lower limbs, Srtide time for left and right lower limbs, Step Cycle Duration (ms), Time of Contact (ms), Swing Duration (ms), Double Support Duration (ms).The findings from the gait analysis are typically documented in a report to be used for statistical analysis.
Time frame
one day2
The STT three-dimensional motion analysis (3DMA) system
The STT three-dimensional motion analysis (3DMA) system (STT Systems Company, Zuatzu Business Park, Easo Building, 2nd Floor, San Sebastián, Spain) was used for the assessment of spatiotemporal characteristics of gait. It is an indoor optical system that consists of four cameras, fifteen markers, and computer software for automatic three-dimensional motion capture and analysis. CLINICAL 3DMA V.6.11 is professional software with highly accurate marker tracking. The STT Helen Hayes protocol was used for the gait analysis in this study.
Time frame
one daySponsors and contacts
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Source ClinicalTrials.gov