NCT07034105

Brief Summary

Gait impairments following a stroke significantly hinder mobility and quality of life, emphasizing the need for precise assessment methods to guide effective rehabilitation strategies. This study evaluates the variability and reliability of spatiotemporal gait parameters across three walking modalities: overground walking, treadmill walking, and body-weight-supported treadmill walking. Using a counterbalanced design, all participants undergo gait analysis in each modality to ensure unbiased and reliable comparisons. The study also incorporates a locally developed, cost-effective Body Weight Support System (BWSS) to address the limitations of accessibility in resource-constrained settings. By identifying how different modalities influence gait variability and reliability, this research aims to optimize rehabilitation outcomes and demonstrate the feasibility of implementing affordable gait analysis tools in clinical practice.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

June 12, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2026

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

April 19, 2025

Last Update Submit

June 14, 2025

Conditions

Keywords

Gait AnalysisSpatiotemporal ParametersBody Weight Support System (BWSS)

Outcome Measures

Primary Outcomes (1)

  • Spatiotemporal Gait Parameter Variability

    The primary outcome measure will be the variability of spatiotemporal gait parameters, including stride length, cadence, and gait speed, assessed during the three walking modalities (Overground, treadmill, and body weight supported treadmill). The variability will be analyses by calculating the standard deviation and coefficient of variation for each parameter across all walking conditions. These measures will reflect the stability and consistency of the patients' gait performance in different walking settings, which is crucial for understanding their rehabilitation progress and the effect of each walking modality on recovery.

    Baseline

Study Arms (1)

Experimental Group - Walking Modalities Comparison

EXPERIMENTAL

This arm will involve stroke patients who undergo all three walking modalities (Overground Walking, Self-Paced Treadmill, and Body-Weight Supported Treadmill) in a counterbalanced order. Each patient will perform all modalities, and the spatiotemporal gait parameters such as stride length, cadence, and gait speed will be measured for analysis. The primary goal is to compare gait parameter variability and reliability across different walking conditions, assessing the effect of each modality on stroke rehabilitation.

Diagnostic Test: Gait Analysis

Interventions

Gait AnalysisDIAGNOSTIC_TEST

* Overground Walking: Stroke patients walk in a natural environment, collecting data on their gait parameters such as stride length, cadence, and gait speed. * Treadmill: Patients walk on a treadmill at their comfortable pace, allowing for more control over their walking speed while measuring the same gait parameters as in overground walking. * Body-Weight Supported Treadmill: Patients walk on a treadmill with a body-weight support system that reduces the load on the legs, enabling patients with more severe impairment to perform walking tasks safely while recording gait parameters.

Experimental Group - Walking Modalities Comparison

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be between 18 to 75 years old.
  • More than 1- month post stroke patient.
  • Participants must be able to walk with or without assistance.
  • Patients including both the male and female.
  • Participants must be able to provide informed consent to participate in the study.

You may not qualify if:

  • Severe cognitive or communicative disorders.
  • Significant joint malposition.
  • Psychological, cognitive dysfunction, and any other neuromuscular problem.
  • Pregnant women will be excluded to avoid any potential risks to the mother and fetus.
  • Unstable cardiovascular disease like congenital heart disease, deep vein thrombosis, coronary heart disease, previous history of heart attack or heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangladesh University of Engineering and Technology

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Interventions

Gait Analysis

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Officials

  • Muhammad Tarik Arafat, PhD

    Department of Biomedical Engineering, Bangladesh University of Engineering and Technology (BUET), Dhaka - 1205.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Tarik Arafat, PhD

CONTACT

Mehedi Hasan Prince, B.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 19, 2025

First Posted

June 24, 2025

Study Start

June 12, 2024

Primary Completion

July 11, 2025

Study Completion

February 11, 2026

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations