NCT07114575

Brief Summary

Stroke is the second leading cause of death and the third leading cause of death combined with disability worldwide. Despite improved recognition and management of stroke risk factors, the risk of stroke has increased by 50% in the last two decades due to increased life expectancy, currently affecting one in every four individuals. If this trend continues, by 2030, it is estimated that 12 million people will die from stroke, and 70 million will live with its consequences. Stroke leads to significant changes in the spatiotemporal parameters of gait. Spatial parameters include step length, stride length, and step width, while temporal parameters comprise cadence, stance phase, double support phase (DSP), and swing phase. Gait speed, incorporating both spatial and temporal elements, is classified as a spatiotemporal parameter. Compared to healthy individuals, people post-stroke tend to have increased DSP and stance phases, shortened step lengths, and widened step widths. Asymmetries between the paretic and non-paretic limbs further disrupt gait symmetry. Previous studies have shown that during prolonged walking tasks such as the 6-minute walk test, both gait speed and symmetry deteriorate in the later stages, potentially due to fatigue. However, changes in walking speed itself may also influence gait symmetry. From this perspective, the aim of this study is to investigate how spatiotemporal gait parameters vary across different walking speeds in individuals with stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2026

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

August 3, 2025

Last Update Submit

March 11, 2026

Conditions

Keywords

strokespatialtemporalwalkinganalysis

Outcome Measures

Primary Outcomes (3)

  • Stance Phase

    Stance phase of hemiplegic side during walking. This outcome will be obtained as a result of the gait analysis

    Baseline

  • Hemiplegic Side Step Length

    Step legth of hemiplegic side during walking. This outcome will be obtained as a result of the gait analysis

    Baseline

  • Double Support Phase

    Double support phase during walking. This outcome will be obtained as a result of the gait analysis

    Baseline

Secondary Outcomes (1)

  • Stride Length

    Baseline

Other Outcomes (3)

  • Fugl Meyer Lower Extremity

    Baseline

  • Berg Balance Scale

    Baseline

  • Functional Ambulation Category

    Baseline

Study Arms (3)

Self Selected Speed

Participants in this group will perform the gait analysis at their preferred comfortable walking speed.

Other: Gait Analysis

Slow Walking Speed

Participants in this group will walk at a speed approximately 25% slower than their comfortable walking speed.

Other: Gait Analysis

Fast Walking Speed

Participants in this group will walk at a speed approximately 25% faster than their comfortable walking speed.

Other: Gait Analysis

Interventions

All participants will undergo gait analysis at three different walking speeds.

Fast Walking SpeedSelf Selected SpeedSlow Walking Speed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke survivors.

You may qualify if:

  • Having an ICD-10 diagnosis code of G.81 Hemiplegia
  • Ability to walk with or without assistance (Functional Ambulation Classification score of 2 or higher)

You may not qualify if:

  • Presence of any known additional neurological or orthopedic condition that may affect walking
  • Inability to complete the tests due to cognitive and/or physical reasons
  • Inability to complete the analysis at walking speeds increased or decreased by 25%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, None Selected, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2025

First Posted

August 11, 2025

Study Start

August 1, 2025

Primary Completion

February 27, 2026

Study Completion

March 10, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations