NCT07524556

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

March 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

March 30, 2026

Last Update Submit

April 5, 2026

Conditions

Keywords

MSwalking fatigabilitygait parametersrisk of falling

Outcome Measures

Primary Outcomes (4)

  • Distance walking index

    measurd as a decline in walking distance between first and last minute more than 10%

    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)

    Baseline

  • Risk of Falling

    Assessed using fall efficacy scale- international and timed up and go test measured in secounds(s)

    Baseline

  • precived fatigue

    assessed by modified fatigue impact scale

    Baseline

Study Arms (2)

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

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

multiple sclerosis specialized clinic in the Neurology department, Faculty of Medicine, Alexandria University.

Alexandria, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Ibrahim Ahmed Elmongy

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
teaching assistant

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations