- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07524556
Walking Fatigability,Saptiotemporal Gait Parameters and Falling in MS Patients (WF-GAIT-FALL)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ibrahim Ahmed Elmongy
- Phone Number: +201061029866
- Email: ibrahem.abm1@gmail.com
Study Locations
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Alexandria, Egypt
- multiple sclerosis specialized clinic in the Neurology department, Faculty of Medicine, Alexandria University.
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Contact:
- multiple sclerosis specialized clinic, Neurology department Faculty of Medicine, Alexandria University
- Phone Number: +201 032 618 685
- Email: Eman.ameen@alexmed.edu.eg
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Principal Investigator:
- Ibrahim Ahmed Elmongy, bacholar
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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G1: fatiged patients
patients with Multiple Sclerosis showing walking fatigability.
They underwent spatiotemporal gait assessment and fatigability testing
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G2: non fatiged patients
patients with Multiple Sclerosis without walking fatigability.
They underwent spatiotemporal gait assessment and fatigability testing
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Distance walking index
Time Frame: Baseline
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measurd as a decline in walking distance between first and last minute more than 10%
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Baseline
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Spatiotemporal Gait Parameters
Time Frame: Baseline
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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)
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Baseline
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Risk of Falling
Time Frame: Baseline
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Assessed using fall efficacy scale- international and timed up and go test measured in secounds(s)
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Baseline
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precived fatigue
Time Frame: Baseline
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assessed by modified fatigue impact scale
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Baseline
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS-WF-GAIT-FALL-2026
- P.T.REC/012/006167 (Registry Identifier: cairo university)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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