Gait Impairment in Stroke PatientsNCT07034105
Spatiotemporal Gait Parameters of Healthy and Stroke Patients During Overground, Treadmill, and Body Weight Supported Treadmill Walking
A study testing Gait Analysis in people with Gait Impairment in Stroke Patients, run by Bangladesh University of Engineering and Technology at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gait Impairment in Stroke Patients
- What is being tested?
- Gait Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBangladesh
- Study dates
- 12 Jun 2024to 11 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Bangladesh University of Engineering and Technology
Dhaka, 1000
Muhammad Tarik Arafat, PhD, +88 01911764467, tarikarafat@bme.buet.ac.bd
About this study
Official title: Variability in Spatiotemporal Gait Parameters of Stroke Patients Across Overground, Self Paced Treadmill, and Body-Weight Supported Treadmill Walking
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.
Read the detailed description
Stroke remains a leading cause of long-term disability, with gait impairments being a prominent challenge that significantly affects functional independence. Accurate and reliable assessment of gait parameters is crucial for tailoring rehabilitation interventions. This study investigates the variability and reliability of spatiotemporal gait parameters, such as stride length, cadence, step time, and gait variability, across three distinct walking modalities:
- Overground walking
- Self paced treadmill walking
- Body weight supported treadmill walking The study employs a counterbalanced design, where each participant performs all three walking modalities, mitigating potential order effects and ensuring robust and reproducible comparisons. Advanced motion analysis systems are utilized to capture high-resolution data, providing insights into the dynamic interplay of gait variability and reliability under each condition.
A key innovation of this study is the use of an in-house, cost-effective Body Weight Support System (BWSS). Unlike commercially available systems, which are often prohibitively expensive, the BWSS is designed for accessibility in resource-limited settings, enabling widespread clinical and research applications. This approach aligns with the study's broader goal of improving healthcare equity by developing practical solutions tailored to local needs.
By analyzing the impact of different walking modalities on gait, the research aims to:
- To analyze the variability and reliability of spatiotemporal gait parameters in stroke patients across overground, treadmill, and body weight supported treadmill walking (BWST). ii. To identify the walking modality that exhibits the most consistent and stable gait metrics. iii. To assess the clinical relevance of gait parameters from different walking modalities to optimize stroke rehabilitation interventions.
This research not only advances the understanding of stroke rehabilitation but also contributes to the global effort to make cutting-edge medical technologies accessible to underserved populations.
- Conditions
- Gait Impairment in Stroke Patients
- Being tested
- Gait Analysis
- Keywords
- Gait Analysis, Spatiotemporal Parameters, Body Weight Support System (BWSS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Gait Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start12 Jun 2024
- Primary completion11 Jul 2025 (estimated)
- Study completion11 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Impairment in Stroke PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh University of Engineering and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Dhaka Medical College
- Responsible party
- Principal investigator, Muhammad Tarik Arafat, Bangladesh University of Engineering and Technology
- Investigators
- Muhammad Tarik Arafat, PhD, Principal investigator, Department of Biomedical Engineering, Bangladesh University of Engineering and Technology (BUET), Dhaka - 1205.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034105
- Sponsor's protocol ID
- BUET/ERC/2024/02
- Status last verified
- Jun 2025
- First submitted
- 19 Apr 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability in Spatiotemporal Gait Parameters of Stroke Patients Across Overground, Self Paced Treadmill, and Body-Weight Supported Treadmill Walking
- ClinicalTrials.gov ID
- NCT07034105
- Acronym / sponsor ID
- BUET/ERC/2024/02
- Conditions
- Gait Impairment in Stroke Patients
- Keywords
- Gait Analysis, Spatiotemporal Parameters, Body Weight Support System (BWSS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Bangladesh University of Engineering and TechnologyUniversity, hospital or other
- Collaborators
- Dhaka Medical College
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 11 Jul 2025 (estimated)
- Study completion
- 11 Feb 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stroke remains a leading cause of long-term disability, with gait impairments being a prominent challenge that significantly affects functional independence. Accurate and reliable assessment of gait parameters is crucial for tailoring rehabilitation interventions. This study investigates the variability and reliability of spatiotemporal gait parameters, such as stride length, cadence, step time, and gait variability, across three distinct walking modalities:
- Overground walking
- Self paced treadmill walking
- Body weight supported treadmill walking The study employs a counterbalanced design, where each participant performs all three walking modalities, mitigating potential order effects and ensuring robust and reproducible comparisons. Advanced motion analysis systems are utilized to capture high-resolution data, providing insights into the dynamic interplay of gait variability and reliability under each condition.
A key innovation of this study is the use of an in-house, cost-effective Body Weight Support System (BWSS). Unlike commercially available systems, which are often prohibitively expensive, the BWSS is designed for accessibility in resource-limited settings, enabling widespread clinical and research applications. This approach aligns with the study's broader goal of improving healthcare equity by developing practical solutions tailored to local needs.
By analyzing the impact of different walking modalities on gait, the research aims to:
- To analyze the variability and reliability of spatiotemporal gait parameters in stroke patients across overground, treadmill, and body weight supported treadmill walking (BWST). ii. To identify the walking modality that exhibits the most consistent and stable gait metrics. iii. To assess the clinical relevance of gait parameters from different walking modalities to optimize stroke rehabilitation interventions.
This research not only advances the understanding of stroke rehabilitation but also contributes to the global effort to make cutting-edge medical technologies accessible to underserved populations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group - Walking Modalities Comparison | Experimental | Diagnostic Test: Gait AnalysisThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait Analysis* 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. | Diagnostic test | Experimental Group - Walking Modalities Comparison |
Primary outcome
Spatiotemporal Gait Parameter Variability
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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Stroke Rehabilitation Through Intensive Exercise
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Walking and Thinking - Brain Activity During Complex Walking in Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammad Tarik Arafat, PhD principal investigator
Department of Biomedical Engineering, Bangladesh University of Engineering and Technology (BUET), Dhaka - 1205.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait Analysis in people with Gait Impairment in Stroke Patients, run by Bangladesh University of Engineering and Technology at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Tarik Arafat, PhD (01911764467, tarikarafat@bme.buet.ac.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatiotemporal Gait Parameter Variability (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.