Multiple SclerosisWF-GAIT-FALLNCT07524556
Walking Fatigability,Saptiotemporal Gait Parameters and Falling in MS Patients
An observational study of Multiple Sclerosis, run by Ibrahim Ahmad Elmongy at 1 site in Egypt.
Trial summary
This observational study aims to investigate the relationship between walking fatigability, changes in spatiotemporal gait parameters, and risk of falling in individuals with multiple sclerosis (MS). Participants will be divided into two groups: those with walking fatigability and those without. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Sixty-two RRMS will be recruited in this study from multiple sclerosis specialized clinic in the Neurology department, Faculty of Medicine, Alexandria University. The patients will be diagnosed and referred to by a neurologist participants aged from 20 to 40 years with a confirmed diagnosis of multiple sclerosis (based on McDonald criteria). Ambulatory for at least 6 minutes, without the use of assistive devices.EDSS score between 2.0 and 5.0.no relapse within 1 month prior to participation
Who may be able to join
- Sixty-two RRMS patients from both sexes.
- Aged from 20 to 40 years with a confirmed diagnosis of multiple sclerosis (based on McDonald criteria).
- Ambulatory for at least 6 minutes, without the use of assistive devices.
- EDSS score between 2.0 and 5.0.
- no relapse within 1 month prior to participation
Who cannot join
- The presence of other neurological or orthopaedic conditions that could affect gait or balance.
- Severe cognitive impairment (as determined by clinical history or physician report).
- Active MS relapses or corticosteroid treatment within the last 30 days.
- Visual or vestibular impairments that significantly interfere with gait or postural control.
- Diabetic patients will be excluded as this will interfere with balance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
multiple sclerosis specialized clinic in the Neurology department, Faculty of Medicine, Alexandria University.
Alexandria
multiple sclerosis specialized clinic, Neurology department Faculty of Medicine, Alexandria University, +201 032 618 685, Eman.ameen@alexmed.edu.eg
Ibrahim Ahmed Elmongy, bacholar
About this study
Official title: Influance of Walking Fatigability on Spatiotemporal Gait Parameters and Risk of Falling in Patients With Multiple Scalerosis
This observational study aims to investigate the relationship between walking fatigability, changes in spatiotemporal gait parameters, and risk of falling in individuals with multiple sclerosis (MS). Participants will be divided into two groups: those with walking fatigability and those without.
Each participant will undergo functional tests to detect deterioration in patiotemoral gait parameters and risk of falling .
The results of this study will help understand how walking fatigability affects gait and fall risk in MS, providing insights for rehabilitation strategies.
Read the detailed description
Multiple sclerosis (MS) is a chronic neurological disease that often affects mobility, balance, and endurance. Walking fatigability, defined as a decline in walking performance over time, is a common problem in individuals with MS and may increase the risk of falls. Understanding how walking fatigability influences gait patterns and fall risk is essential for designing targeted rehabilitation strategies.
This observational study aims to investigate the relationship between walking fatigability, spatiotemporal gait parameters, and fall risk in individuals with MS. Participants will be recruited from Alexandria University Hospital and will be divided into two groups based on the presence or absence of walking fatigability. Inclusion criteria include confirmed MS diagnosis, ability to walk independently, and willingness to provide informed consent. Exclusion criteria include acute MS relapse, comorbid conditions affecting gait, or cognitive impairment that prevents safe participation.
Participants will undergo 6-Minute Walk Test to assess walking performance, and gait parameters such as step length and double time support.and gait speed will be recorded. Fall risk will be evaluated using a Timed Up and Go (TUG) test and The Falls Efficacy Scale-International (FES-I).
Data will be analyzed to compare gait changes and fall risk between the two groups. Correlations between walking fatigability and specific gait parameters will be explored to identify patterns associated with higher fall risk. The findings of this study are expected to inform clinical decision-making and rehabilitation approaches, contributing to safer and more effective mobility management for individuals with MS.
- Conditions
- Multiple Sclerosis
- Keywords
- MS, walking fatigability, gait parameters, risk of falling
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| G1: fatiged patients | patients with Multiple Sclerosis showing walking fatigability. They underwent spatiotemporal gait assessment and fatigability testing | |
| G2: non fatiged patients | patients with Multiple Sclerosis without walking fatigability. They underwent spatiotemporal gait assessment and fatigability testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walking index
measurd as a decline in walking distance between first and last minute more than 10%
Measured: Baseline
Spatiotemporal Gait Parameters
includes step length in meter(m) , gait velocity in meter per secound(m/s) and double time support in secounds(s) measured using gait analysis tool ( kinovea software)
Measured: Baseline
Risk of Falling
Assessed using fall efficacy scale- international and timed up and go test measured in secounds(s)
Measured: Baseline
precived fatigue
assessed by modified fatigue impact scale
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ibrahim Ahmad Elmongy
- Sponsor type
- University, hospital or other
- Collaborators
- Horus University
- Responsible party
- Sponsor-investigator, Ibrahim Ahmad Elmongy, Horus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524556
- Sponsor's protocol ID
- MS-WF-GAIT-FALL-2026
- Other IDs
- P.T.REC/012/006167
- Acronym
- WF-GAIT-FALL
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influance of Walking Fatigability on Spatiotemporal Gait Parameters and Risk of Falling in Patients With Multiple Scalerosis
- ClinicalTrials.gov ID
- NCT07524556
- Acronym / sponsor ID
- WF-GAIT-FALL / MS-WF-GAIT-FALL-2026
- Conditions
- Multiple Sclerosis
- Keywords
- MS, walking fatigability, gait parameters, risk of falling
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Ibrahim Ahmad ElmongyUniversity, hospital or other
- Collaborators
- Horus University
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 13 Apr 2026 (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 observational study aims to investigate the relationship between walking fatigability, changes in spatiotemporal gait parameters, and risk of falling in individuals with multiple sclerosis (MS). Participants will be divided into two groups: those with walking fatigability and those without.
Each participant will undergo functional tests to detect deterioration in patiotemoral gait parameters and risk of falling .
The results of this study will help understand how walking fatigability affects gait and fall risk in MS, providing insights for rehabilitation strategies.
Detailed description
Multiple sclerosis (MS) is a chronic neurological disease that often affects mobility, balance, and endurance. Walking fatigability, defined as a decline in walking performance over time, is a common problem in individuals with MS and may increase the risk of falls. Understanding how walking fatigability influences gait patterns and fall risk is essential for designing targeted rehabilitation strategies.
This observational study aims to investigate the relationship between walking fatigability, spatiotemporal gait parameters, and fall risk in individuals with MS. Participants will be recruited from Alexandria University Hospital and will be divided into two groups based on the presence or absence of walking fatigability. Inclusion criteria include confirmed MS diagnosis, ability to walk independently, and willingness to provide informed consent. Exclusion criteria include acute MS relapse, comorbid conditions affecting gait, or cognitive impairment that prevents safe participation.
Participants will undergo 6-Minute Walk Test to assess walking performance, and gait parameters such as step length and double time support.and gait speed will be recorded. Fall risk will be evaluated using a Timed Up and Go (TUG) test and The Falls Efficacy Scale-International (FES-I).
Data will be analyzed to compare gait changes and fall risk between the two groups. Correlations between walking fatigability and specific gait parameters will be explored to identify patterns associated with higher fall risk. The findings of this study are expected to inform clinical decision-making and rehabilitation approaches, contributing to safer and more effective mobility management for individuals with MS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1: fatiged patients | – | –patients with Multiple Sclerosis showing walking fatigability. They underwent spatiotemporal gait assessment and fatigability testing |
| G2: non fatiged patients | – | –patients with Multiple Sclerosis without walking fatigability. They underwent spatiotemporal gait assessment and fatigability testing |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Sixty-two RRMS will be recruited in this study from multiple sclerosis specialized clinic in the Neurology department, Faculty of Medicine, Alexandria University. The patients will be diagnosed and referred to by a neurologist participants aged from 20 to 40 years with a confirmed diagnosis of multiple sclerosis (based on McDonald criteria). Ambulatory for at least 6 minutes, without the use of assistive devices.EDSS score between 2.0 and 5.0.no relapse within 1 month prior to participation
Key inclusion criteria (5 listed)
- Sixty-two RRMS patients from both sexes.
- Aged from 20 to 40 years with a confirmed diagnosis of multiple sclerosis (based on McDonald criteria).
- Ambulatory for at least 6 minutes, without the use of assistive devices.
- EDSS score between 2.0 and 5.0.
- no relapse within 1 month prior to participation
Key exclusion criteria (5 listed)
- The presence of other neurological or orthopaedic conditions that could affect gait or balance.
- Severe cognitive impairment (as determined by clinical history or physician report).
- Active MS relapses or corticosteroid treatment within the last 30 days.
- Visual or vestibular impairments that significantly interfere with gait or postural control.
- Diabetic patients will be excluded as this will interfere with balance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distance walking index
Time frame: Baseline
measurd as a decline in walking distance between first and last minute more than 10%
Spatiotemporal Gait Parameters
Time frame: Baseline
includes step length in meter(m) , gait velocity in meter per secound(m/s) and double time support in secounds(s) measured using gait analysis tool ( kinovea software)
Risk of Falling
Time frame: Baseline
Assessed using fall efficacy scale- international and timed up and go test measured in secounds(s)
precived fatigue
Time frame: Baseline
assessed by modified fatigue impact scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- 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.
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 Multiple Sclerosis, run by Ibrahim Ahmad Elmongy 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Ahmed Elmongy (+201061029866, ibrahem.abm1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance walking index (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.