CClinicalTrials.gg
RecruitingNCT06468891GPWSUIUpdated Jun 21, 2024

Analyzing Gait Parameters Among Women With and Without Stress Urinary Incontinence

An observational study in Gait, Stress Urinary Incontinence and Women, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-06-21.

Sponsored by Cairo University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
124
Ages
40 Years to 60 Years
Sex
Female
01

Study 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

Read the 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).

02

Conditions studied

  • Gait
  • Stress Urinary Incontinence
  • Women
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's planned enrollment of 124 is close to the median of 120 across 305 observational studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
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.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
124 participants (estimated)
Patient registry
No

Groups and cohorts

  • women with stress urinary incontinence

    This group includes 62 participants with chronic stress urinary incontinence.

    Other: Incontinence Symptom Severity Index · Other: Force platform · Other: The STT three-dimensional motion analysis (3DMA) system

  • 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 · Other: Force platform · Other: The STT three-dimensional motion analysis (3DMA) system

Interventions

  • OtherIncontinence 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

    Also known as: (ISSI).

  • OtherForce 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.

  • OtherThe 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.

06

What researchers measure

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 day

Secondary 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 day

  2. 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 day

07

Study locations

1 of 1 sites recruiting
  • Faculty of Physiotherapy
    Cairo, 11432, Egypt
    Recruiting
08

References and documents

Publications

  • 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. PubMed 38398293 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06468891
Lead sponsor
Cairo University
Responsible party
Hany Mohamed Ibrahim Elgohary (Cairo University, Cairo University) — Principal investigator
First posted
Jun 21, 2024
Start date
Jun 16, 2024
Primary completion
Aug 20, 2024 (estimated)
Completion
Aug 30, 2024 (estimated)
Last update
Jun 21, 2024

Study contacts

Alaa M Khedr, BSc
Contact
alaa.khedr@deltauniv.edu.eg
00201555001550
Fayiz F El Shamy, PhD
Contact
ff_elshamy@yahoo.com
00201091050154

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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