Analyzing Gait Parameters Among Women With and Without Stress Urinary Incontinence
GPWSUI
1 other identifier
observational
124
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2024
CompletedStudy Start
First participant enrolled
June 16, 2024
CompletedFirst Posted
Study publicly available on registry
June 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedJune 21, 2024
June 1, 2024
2 months
June 16, 2024
June 16, 2024
Conditions
Outcome Measures
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.
one day
Secondary Outcomes (2)
Force platform
one day
The STT three-dimensional motion analysis (3DMA) system
one day
Study Arms (2)
women with stress urinary incontinence
This group includes 62 participants with chronic stress urinary incontinence.
women without stress urinary incontinence
This group includes 62 participants who are free from urinary incontinence symptoms and pelvic floor dysfunction.
Interventions
* 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
Use 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 (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.
Eligibility Criteria
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.
You may qualify if:
- 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.
- All participants will be of multiparas.
- All participants will be diagnosed with a mild degree of stress urinary incontinence.
You may not qualify if:
- 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
- Previous pelvic surgery as pelvic organ prolapse repair or anti-incontinence procedures.
- Other significant medical conditions that could affect gait include severe cardiovascular disease or severe respiratory conditions.
- Walking pain.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Physiotherapy
Cairo, 11432, Egypt
Related Publications (1)
Elabd OM, Etoom M, Jahan AM, Elabd AM, Khedr AM, Elgohary HM. The Efficacy of Muscle Energy and Mulligan Mobilization Techniques for the Upper Extremities and Posture after Breast Cancer Surgery with Axillary Dissection: A Randomized Controlled Trial. J Clin Med. 2024 Feb 8;13(4):980. doi: 10.3390/jcm13040980.
PMID: 38398293RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cairo University
Study Record Dates
First Submitted
June 16, 2024
First Posted
June 21, 2024
Study Start
June 16, 2024
Primary Completion
August 20, 2024
Study Completion
August 30, 2024
Last Updated
June 21, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share