Analyzing Gait Parameters Among Women With and Without Stress Urinary Incontinence

NCT ID: NCT06468891

Last Updated: 2024-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-16

Study Completion Date

2024-08-30

Brief Summary

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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

Detailed Description

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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).

Conditions

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Gait Stress Urinary Incontinence Women

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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women with stress urinary incontinence

This group includes 62 participants with chronic stress urinary incontinence.

Incontinence Symptom Severity Index

Intervention Type OTHER

* 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

Intervention Type OTHER

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

Intervention Type OTHER

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.

women without stress urinary incontinence

This group includes 62 participants who are free from urinary incontinence symptoms and pelvic floor dysfunction.

Incontinence Symptom Severity Index

Intervention Type OTHER

* 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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Interventions

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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

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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(ISSI).

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hany Mohamed Ibrahim Elgohary

Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Physiotherapy

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Alaa M Khedr, BSc

Role: CONTACT

00201555001550

Fayiz F El Shamy, PhD

Role: CONTACT

00201091050154

Facility Contacts

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Fayez F al-Shami, PhD

Role: primary

00201091050154

Amr A Abu-Jazia, PhD

Role: backup

00201008000340

References

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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.

Reference Type RESULT
PMID: 38398293 (View on PubMed)

Related Links

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Other Identifiers

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KFSIRB200- 249

Identifier Type: -

Identifier Source: org_study_id

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