NCT07233044

Brief Summary

The aim of this study is to assess both immediate and long-term effects of visually-guided gait training on balance, mobility, and risk of falling in patients with multiple sclerosis.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
active not 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

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

November 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

December 22, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 14, 2025

Last Update Submit

December 16, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Dynamic Balance Performance (%):

    The percentage score representing how accurately the participant maintained the red spot path within the designated frame during the dynamic balance test. A higher percentage indicates better balance control and greater stability.

    8 weeks and follow up after 4 weeks.

  • Front Average Deviation

    The mean displacement of the participant's center of pressure (COP) in the forward (anterior) direction.

    8 weeks and follow up after 4 weeks

  • Back Average Deviation

    The mean displacement of the participant's center of pressure (COP) in the backward (posterior) direction.

    8 weeks and follow up after 4 weeks

  • Right Average Deviation

    The mean displacement of the participant's center of pressure (COP) in the right (lateral) direction.

    8 weeks and follow up after 4 weeks

  • Left Average Deviation

    The mean displacement of the participant's center of pressure (COP) in the left (lateral) direction.

    8 weeks and follow up after 4 weeks

Secondary Outcomes (3)

  • The Four-Square Step Test (FSST)

    8 weeks and follow up after 4 weeks

  • The Ten-Meter Walk Test (10MWT)

    8 weeks and follow up after 4 weeks

  • Arabic version of Falls Efficacy Scale-International (FES-I)

    8 weeks and follow up after 4 weeks

Study Arms (2)

Visually-guided gait training + Conventional gait training

EXPERIMENTAL

This group will consist of twenty patients, who will receive visually-guided gait training and conventional gait training for 8 weeks.

Other: Visually-guided gait trainingOther: Conventional gait training

Conventional gait training

ACTIVE COMPARATOR

This group will consist of twenty patients, who will receive conventional gait training only for 8 weeks.

Other: Conventional gait training

Interventions

The program runs for eight weeks, with two 60-minute sessions per week, integrating gaze strategy, task-specific mobility, and dual-task cognitive training. Participants first learn systematic visual scanning using saccades and gridline searches. In task-specific training, they perform precision walking-stepping accurately on targets-and obstacle avoidance, navigating a 6 m path with variable pole positions to enhance visual-motor coordination. Finally, dual-task training adds cognitive challenges, such as word generation or backward counting, to improve attention, adaptability, and functional mobility.

Visually-guided gait training + Conventional gait training

It will be received for eight weeks, twice per week, each session lasting 30 minutes, consisting of standing and walking activities maintaining a stable base of support; static postural control exercises, weight shifting and perturbations exercises, weight-bearing exercises through lower limbs; and adequate weight transfer and forward progression with trunk, limb, and pelvic kinematics consistent with safe walking, walking forward and backward, side-stepping, standing and walking on varied surfaces.

Conventional gait trainingVisually-guided gait training + Conventional gait training

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically definite MS (relapsing and remitting) patients who are stable for at least three months.
  • Expanded Disability Status Scale (EDSS) score of ≤ 4 (fully ambulatory, self-sufficient, and able to stand and walk without any aid or orthosis at least 500 meters) to minimize the impact of motor weakness interfering with their ability to perform the task.
  • Normal or corrected to normal vision, wearing eyeglasses.
  • The age will range from 20 - 45 years.
  • All patients with MS were required to report subjective perceived imbalance or history of falls (in the last year)

You may not qualify if:

  • Patients with any other neurological deficits or orthopedics abnormalities.
  • Patients with secondary musculoskeletal complications such as fractures, contractures, or deformities.
  • Patients with vision problems that impaired walking ability.
  • Patients with severe cognitive impairment or psychological disorders impaired the ability to follow the procedures of the study.
  • Patients with cardiovascular and respiratory diseases.
  • Patients with serious unstable medical condition or Patients had an acute exacerbation of MS within last month.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University Hospital

Kafr ash Shaykh, 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

Study Officials

  • Abeer Abo Bakr, PhD

    Professor, Cairo university

    STUDY CHAIR
  • Ibrahim Hamoda, PhD

    Assistant professor, Kafr Elsheikh univeristy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

November 30, 2025

Primary Completion

April 20, 2026

Study Completion

April 30, 2026

Last Updated

December 22, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations