Analyzing Gait Parameters Among Women With and Without Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

— GPWSUI  

Official title:

Analyzing Gait Parameters Among Women With and Without Stress Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06468891
• Other study ID #: KFSIRB200- 249
• Status: Recruiting
• Start date: June 16, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2024
• Source: Cairo University
• Contact: Alaa M Khedr, BSc
• Phone: 00201555001550
• Email: alaa.khedr[@]deltauniv.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Use the provided software or tools to analyze the recorded data, including (cadence, velocity, swing, and double limb support, stride time, step length, and stride length) of gait. The software measures the cadence as total number of steps per minute, and it measures the stride time as the time (in sec) from heel strike of one limb to the next heel strike of the same limb. Also, the software measures the duration of stance, swing, and double limb support as percentage of stride time. Also, the software measures the step and stride length (in cm).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: August 30, 2024
• Est. primary completion date: August 20, 2024
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Enuresis
• Gait
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress
• Women

Intervention

Other:
• Incontinence Symptom Severity Index
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
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
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.

Locations

Country	Name	City	State
Egypt	Faculty of Physiotherapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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 C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	one day
Secondary	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.	one day

External Links

•   research paper