Analyzing Gait Parameters Among Women With and Without Stress Urinary Incontinence (GPWSUI)

June 16, 2024 updated by: Hany Mohamed Ibrahim Elgohary, Cairo University
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Estimated)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11432
        • Recruiting
        • Faculty of Physiotherapy
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
women with stress urinary incontinence
This group includes 62 participants with chronic stress urinary incontinence.
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
Other Names:
  • (ISSI).
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.
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.
women without stress urinary incontinence
This group includes 62 participants who are free from urinary incontinence symptoms and pelvic floor dysfunction.
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
Other Names:
  • (ISSI).
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incontinence Symptom Severity Index
Time Frame: one day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Force platform
Time Frame: one day
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
The STT three-dimensional motion analysis (3DMA) system
Time Frame: one day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2024

Primary Completion (Estimated)

August 20, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

June 16, 2024

First Submitted That Met QC Criteria

June 16, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 16, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFSIRB200- 249

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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