GaitGPWSUINCT06468891
Analyzing Gait Parameters Among Women With and Without Stress Urinary Incontinence
An observational study of Gait and Stress Urinary Incontinence, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Gait, Stress Urinary Incontinence, Women
- What is being tested?
- Incontinence Symptom Severity Index, Force platform and The STT three-dimensional motion analysis (3DMA) system
- How many people
- 124 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jun 2024to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physiotherapy
Cairo, 11432
Fayez F al-Shami, PhD, 00201091050154, ff_elshamy@yahoo.com
Amr A Abu-Jazia, PhD, 00201008000340, ff_elshamy@yahoo.com
About this study
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).
- Conditions
- Gait, Stress Urinary Incontinence, Women
- Being tested
- Incontinence Symptom Severity Index, Force platform, The STT three-dimensional motion analysis (3DMA) system
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incontinence Symptom Severity IndexOther
Also called (ISSI).
- 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 platformOther
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) systemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| women with stress urinary incontinence | This group includes 62 participants with chronic stress urinary incontinence. Receives: 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. Receives: Other: Incontinence Symptom Severity Index; Other: Force platform; Other: The STT three-dimensional motion analysis (3DMA) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Secondary outcomes (2)
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.
Measured: one day
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start16 Jun 2024
- Primary completion20 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GaitStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Mohamed Ibrahim Elgohary, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468891
- Sponsor's protocol ID
- KFSIRB200- 249
- Acronym
- GPWSUI
- Status last verified
- Jun 2024
- First submitted
- 16 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing Gait Parameters Among Women With and Without Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06468891
- Acronym / sponsor ID
- GPWSUI / KFSIRB200- 249
- Conditions
- Gait, Stress Urinary Incontinence, Women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Jun 2024 (actual)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with stress urinary incontinence | – | Other: Incontinence Symptom Severity Index, Other: Force platform, Other: The STT three-dimensional motion analysis (3DMA) systemThis group includes 62 participants with chronic stress urinary incontinence. |
| women without stress urinary incontinence | – | Other: Incontinence Symptom Severity Index, Other: Force platform, Other: The STT three-dimensional motion analysis (3DMA) systemThis group includes 62 participants who are free from urinary incontinence symptoms and pelvic floor dysfunction. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incontinence Symptom Severity IndexAlso: (ISSI).* 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 | women with stress urinary incontinence, women without stress urinary incontinence |
| Force platformUse 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 | women with stress urinary incontinence, women without stress urinary incontinence |
| The STT three-dimensional motion analysis (3DMA) systemThe 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. | Other | women with stress urinary incontinence, women without stress urinary incontinence |
Primary outcome
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.
2 secondary outcomes
Force platform
Time frame: one day
The STT three-dimensional motion analysis (3DMA) system
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Results publication: PubMed 38398293Elabd 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.
- research paperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait and Stress Urinary Incontinence, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa M Khedr, BSc (00201555001550, alaa.khedr@deltauniv.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence Symptom Severity Index (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06468891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.