StrokeNCT04877249
Gait Training in Post-Stroke Hemiparesis Hemiparesis
A study testing Split-belt treadmill training in people with Stroke, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The focus of this study is to optimize the delivery of a combined strength and aerobic training regimen to individuals with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Split-belt treadmill training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2021to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals, ages 20 or older
- Healthy participants will be required to be medically stable
- Healthy participants are able to walk at least 10 meters independently at a comfortable speed without an assistive device
- The participants with a history stroke, ages 20 or older
- Unilateral first stroke of ischemic origin in the carotid artery distribution
- Unilateral first stroke of hemorrhagic origin in the carotid artery distribution
Show all 10Show fewer
- Diagnosis of stroke at least 6 months prior to participation
- Free of major post-stroke complications (e.g., recurrent stroke, hip fracture, myocardial infarction)
- Living within the community
- The participants with a history stroke are able to ambulate 10 meters with or without assistive devices
Who cannot join
- A history of any significant orthopedic problems
- A history of psychiatric or cognitive illness (e.g., bipolar affective disorder, psychosis, schizophrenia, attention deficits, cognitive deficits, or medication refractor depression)
- Neurological problems
- Stroke secondary to subarachnoid hemorrhage or posterior circulation stroke
- Not expected to live more than one year
- Comatose
Show all 18Show fewer
- Unable to follow 3 step commands
- Amputation
- Poorly controlled diabetes (e.g., foot ulceration)
- Blind
- Progressive neurological diseases
- Comprehensive aphasia
- Medical instability
- Significant musculoskeletal problems
- Congestive cardiac failure
- Unstable angina
- Peripheral vascular disease
- Neuropsychiatric disorders (e.g., dementia, cognitive deficits, and severe depression)
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Health Profession, University of Texas Medical Branch
Galveston, Texas, 77550
About this study
Official title: Gait Training to Reduce Compensatory Walking Patterns in Post-Stroke Hemiparesis
The focus of this study is to optimize the delivery of a combined strength and aerobic training regimen to individuals with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. This study proposes to use 1) split-belt treadmill and 2) single belt treadmill walking using split belt simulation software for enhancing symmetrical walking patterns for people with stroke.
Read the detailed description
This study will include twenty stroke survivors and twenty healthy adults (total 40 participants) who are 20 years or older. Both groups (stroke vs healthy) will be screened and recruited from a UTMB Stroke Support Group and local community in Galveston or Harris County for one year (2021-22). Healthy individuals will also participate in gait training compared to stroke participants. The focus of this gait training is to optimize the delivery of a combined strength and aerobic training regimen to older adults with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. Investigators propose to use a combination of neuromechanical and biobehavioral approaches to enhance bilateral symmetry of limb propulsion using specialized split-belt, force-plate instrumented treadmill that uses backward directed resistance forces. With neuromechanics investigators will measure joint torque output, EMG muscle activity patterns, and trailing limb angle, while a person is walking under normal treadmill belt conditions versus the split-belt conditions at different levels of resistance. Electromyography (EMG) detects electrical activity during muscle contraction while the single or the split-belt treadmill walking. The joint torque output and trailing limb angle can be obtained by using the Vicon Motion System (Vicon, Oxford, UK) in conjunction with the Bertec split-belt, force plates instrumented treadmill (Bertec Corp., Columbus, OH). In addition, in terms of biobehavioral metrics, investigators will measure the extent to which people maintain improved paretic limb propulsion contributions immediately after the split-belt environment is restored to a single belt condition (i.e. aftereffects), and the ability of individuals to consciously alter their walking pattern so as to reduce compensatory walking patterns when they are not engaged with the specialized treadmill setup.
- Conditions
- Stroke
- Being tested
- Split-belt treadmill training
- Keywords
- Hemiparesis, Split-belt treadmill, gait training
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-belt treadmill trainingBehavioural
- Split-belt gait training without or with any resistance, 2. Facilitating the knee extension during the terminal swing phase of gait cycle to identify the impact on the propulsive force generation of paretic leg
| Study group | Role | What they receive |
|---|---|---|
| Gait training for stroke | Experimental | Not described Receives: Behavioral: Split-belt treadmill training |
| Gait training for healthy | Active comparator | Not described Receives: Behavioral: Split-belt treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral symmetry of ground reaction forces during split-belt treadmill walking
Vertical, horizontal, and mediolateral ground reaction force changes will be measured in response to split/tied belt speed and with (or without) a resistance using the Bertec split-belt, force plates instrumented treadmill and the Vicon 3D motion analysis system.
Measured: Single point of assessment in one day and ground reaction forces will be recorded continuously for 20-30minutes and will be expressed per gait cycle
Bilateral symmetry of joint torques during split-belt treadmill walking
Joint torques changes of ankle, knee, and hip joints will be measured in response to split/tied belt speed and with (or without) a resistance using the Bertec split-belt, force plates instrumented treadmill and the Vicon 3D motion analysis system.
Measured: Single point of assessment in one day and joint torques will be recorded continuously for 20-30minutes and will be expressed per gait cycle
Trailing limb angle during split-belt treadmill walking
Peak trailing limb angle changes will be measured in response to split/tied belt speed and with (or without) a resistance using the Bertec split-belt, force plates instrumented treadmill and the Vicon 3D motion analysis system.
Measured: Single point of assessment in one day and trailing limb angle will be recorded continuously for 20-30minutes and will be expressed per gait cycle
Bilateral muscles activities during split-belt treadmill walking
Timing (milliseconds) of Soleus, Tibialis Anterior, and Quadriceps muscle activities changes will be recorded continuously in response to split/tied belt speed and with (or without) a resistance using Delsys wireless EMG system.
Measured: Single point of assessment in one day and muscle activity will be recorded continuously for 20-30minutes and will be expressed per gait cycle
Bilateral muscles activities during split-belt treadmill walking
Peak amplitude (millivolts) of Soleus, Tibialis Anterior, and Quadriceps muscle activities changes will be recorded continuously in response to split/tied belt speed and with (or without) a resistance using Delsys wireless EMG system.
Measured: Single point of assessment in one day and muscle activity will be recorded continuously for 20-30minutes and will be expressed per gait cycle
Spatiotemporal patterns during split-belt treadmill walking
Cadence (Step numbers/minute) during split/tied treadmill walking will be recorded continuously using the Vicon 3D motion analysis system.
Measured: Single point of assessment in one day and spatiotemporal gait parameters will be recorded continuously for 20-30minutes and will be expressed per gait cycle.
Spatiotemporal patterns during split-belt treadmill walking
Step and stride length (cm) during split/tied treadmill walking will be recorded continuously using the Vicon 3D motion analysis system.
Measured: Single point of assessment in one day and spatiotemporal gait parameters will be recorded continuously for 20-30minutes and will be expressed per gait cycle.
Spatiotemporal patterns during split-belt treadmill walking
Stance and swing time (sec) during split/tied treadmill walking will be recorded continuously using the Vicon 3D motion analysis system.
Measured: Single point of assessment in one day and spatiotemporal gait parameters will be recorded continuously for 20-30minutes and will be expressed per gait cycle.
Secondary outcomes (6)
Spatiotemporal patterns of overground walking
Walking speed (m/sec) during overground walking will be recorded continuously using the Zeno Walkway system.
Measured: Baseline assessment before split/tied treadmill walking
Spatiotemporal patterns of overground walking
Cadence (Step numbers/minute) during overground walking will be recorded continuously using the Zeno Walkway system.
Measured: Baseline assessment before split/tied treadmill walking
Spatiotemporal patterns of overground walking
Step and stride length (cm) during overground walking will be recorded continuously using the Zeno Walkway system.
Measured: Baseline assessment before split/tied treadmill walking
Spatiotemporal patterns of overground walking
Stance and swing time (sec) during overground walking will be recorded continuously using the Zeno Walkway system.
Measured: Baseline assessment before split/tied treadmill walking
Kinematic representation of the temporal events during standing and walking
The temporal events of foot position (sec) will be identified from ground reaction forces (GRFs) during standing and walking trials using the Tekscan High Resolution Mat.
Measured: Baseline assessment before split/tied treadmill walking
Kinematic representation of the temporal events during standing and walking
The standing balance (cm2) will be measured using sway analysis from Tekscan High Resolution Mat.
Measured: Baseline assessment before split/tied treadmill walking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start9 Jul 2021
- Primary completion5 Jun 2024
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mansoo Ko, Ph.D., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877249
- Sponsor's protocol ID
- 20-0091
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2021
- Last updated
- 11 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moradian N, Ko M, Hurt CP, Brown DA. Effects of backward-directed resistance on propulsive force generation during split-belt treadmill walking in non-impaired individuals. Front Hum Neurosci. 2023 Dec 4;17:1214967. doi: 10.3389/fnhum.2023.1214967. eCollection 2023.
PubMed 38111676
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Training to Reduce Compensatory Walking Patterns in Post-Stroke Hemiparesis
- ClinicalTrials.gov ID
- NCT04877249
- Acronym / sponsor ID
- 20-0091
- Conditions
- Stroke
- Keywords
- Hemiparesis, Split-belt treadmill, gait training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 7 May 2021 (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.
The focus of this study is to optimize the delivery of a combined strength and aerobic training regimen to individuals with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. This study proposes to use 1) split-belt treadmill and 2) single belt treadmill walking using split belt simulation software for enhancing symmetrical walking patterns for people with stroke.
Detailed description
This study will include twenty stroke survivors and twenty healthy adults (total 40 participants) who are 20 years or older. Both groups (stroke vs healthy) will be screened and recruited from a UTMB Stroke Support Group and local community in Galveston or Harris County for one year (2021-22). Healthy individuals will also participate in gait training compared to stroke participants. The focus of this gait training is to optimize the delivery of a combined strength and aerobic training regimen to older adults with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. Investigators propose to use a combination of neuromechanical and biobehavioral approaches to enhance bilateral symmetry of limb propulsion using specialized split-belt, force-plate instrumented treadmill that uses backward directed resistance forces. With neuromechanics investigators will measure joint torque output, EMG muscle activity patterns, and trailing limb angle, while a person is walking under normal treadmill belt conditions versus the split-belt conditions at different levels of resistance. Electromyography (EMG) detects electrical activity during muscle contraction while the single or the split-belt treadmill walking. The joint torque output and trailing limb angle can be obtained by using the Vicon Motion System (Vicon, Oxford, UK) in conjunction with the Bertec split-belt, force plates instrumented treadmill (Bertec Corp., Columbus, OH). In addition, in terms of biobehavioral metrics, investigators will measure the extent to which people maintain improved paretic limb propulsion contributions immediately after the split-belt environment is restored to a single belt condition (i.e. aftereffects), and the ability of individuals to consciously alter their walking pattern so as to reduce compensatory walking patterns when they are not engaged with the specialized treadmill setup.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gait training for stroke | Experimental | Behavioral: Split-belt treadmill training |
| Gait training for healthy | Active comparator | Behavioral: Split-belt treadmill training |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy individuals, ages 20 or older
- Healthy participants will be required to be medically stable
- Healthy participants are able to walk at least 10 meters independently at a comfortable speed without an assistive device
- The participants with a history stroke, ages 20 or older
- Unilateral first stroke of ischemic origin in the carotid artery distribution
Key exclusion criteria (18 listed)
- A history of any significant orthopedic problems
- A history of psychiatric or cognitive illness (e.g., bipolar affective disorder, psychosis, schizophrenia, attention deficits, cognitive deficits, or medication refractor depression)
- Neurological problems
- Stroke secondary to subarachnoid hemorrhage or posterior circulation stroke
- Not expected to live more than one year
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 |
|---|---|---|
| Split-belt treadmill training1. Split-belt gait training without or with any resistance, 2. Facilitating the knee extension during the terminal swing phase of gait cycle to identify the impact on the propulsive force generation of paretic leg | Behavioural | Gait training for healthy, Gait training for stroke |
Primary outcome
Bilateral symmetry of ground reaction forces during split-belt treadmill walking
Time frame: Single point of assessment in one day and ground reaction forces will be recorded continuously for 20-30minutes and will be expressed per gait cycle
Vertical, horizontal, and mediolateral ground reaction force changes will be measured in response to split/tied belt speed and with (or without) a resistance using the Bertec split-belt, force plates instrumented treadmill and the Vicon 3D motion analysis system.
Bilateral symmetry of joint torques during split-belt treadmill walking
Time frame: Single point of assessment in one day and joint torques will be recorded continuously for 20-30minutes and will be expressed per gait cycle
Joint torques changes of ankle, knee, and hip joints will be measured in response to split/tied belt speed and with (or without) a resistance using the Bertec split-belt, force plates instrumented treadmill and the Vicon 3D motion analysis system.
Trailing limb angle during split-belt treadmill walking
Time frame: Single point of assessment in one day and trailing limb angle will be recorded continuously for 20-30minutes and will be expressed per gait cycle
Peak trailing limb angle changes will be measured in response to split/tied belt speed and with (or without) a resistance using the Bertec split-belt, force plates instrumented treadmill and the Vicon 3D motion analysis system.
Bilateral muscles activities during split-belt treadmill walking
Time frame: Single point of assessment in one day and muscle activity will be recorded continuously for 20-30minutes and will be expressed per gait cycle
Timing (milliseconds) of Soleus, Tibialis Anterior, and Quadriceps muscle activities changes will be recorded continuously in response to split/tied belt speed and with (or without) a resistance using Delsys wireless EMG system.
Bilateral muscles activities during split-belt treadmill walking
Time frame: Single point of assessment in one day and muscle activity will be recorded continuously for 20-30minutes and will be expressed per gait cycle
Peak amplitude (millivolts) of Soleus, Tibialis Anterior, and Quadriceps muscle activities changes will be recorded continuously in response to split/tied belt speed and with (or without) a resistance using Delsys wireless EMG system.
Spatiotemporal patterns during split-belt treadmill walking
Time frame: Single point of assessment in one day and spatiotemporal gait parameters will be recorded continuously for 20-30minutes and will be expressed per gait cycle.
Cadence (Step numbers/minute) during split/tied treadmill walking will be recorded continuously using the Vicon 3D motion analysis system.
Spatiotemporal patterns during split-belt treadmill walking
Time frame: Single point of assessment in one day and spatiotemporal gait parameters will be recorded continuously for 20-30minutes and will be expressed per gait cycle.
Step and stride length (cm) during split/tied treadmill walking will be recorded continuously using the Vicon 3D motion analysis system.
Spatiotemporal patterns during split-belt treadmill walking
Time frame: Single point of assessment in one day and spatiotemporal gait parameters will be recorded continuously for 20-30minutes and will be expressed per gait cycle.
Stance and swing time (sec) during split/tied treadmill walking will be recorded continuously using the Vicon 3D motion analysis system.
6 secondary outcomes
Spatiotemporal patterns of overground walking
Time frame: Baseline assessment before split/tied treadmill walking
Spatiotemporal patterns of overground walking
Time frame: Baseline assessment before split/tied treadmill walking
Spatiotemporal patterns of overground walking
Time frame: Baseline assessment before split/tied treadmill walking
Spatiotemporal patterns of overground walking
Time frame: Baseline assessment before split/tied treadmill walking
Kinematic representation of the temporal events during standing and walking
Time frame: Baseline assessment before split/tied treadmill walking
Kinematic representation of the temporal events during standing and walking
Time frame: Baseline assessment before split/tied treadmill walking
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 38111676Moradian N, Ko M, Hurt CP, Brown DA. Effects of backward-directed resistance on propulsive force generation during split-belt treadmill walking in non-impaired individuals. Front Hum Neurosci. 2023 Dec 4;17:1214967. doi: 10.3389/fnhum.2023.1214967. eCollection 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mansoo Ko, Ph.D. principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split-belt treadmill training in people with Stroke, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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 10 inclusion and 18 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: finished, as of the sponsor's last update on 11 Apr 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral symmetry of ground reaction forces during split-belt treadmill walking (time frame: Single point of assessment in one day and ground reaction forces will be recorded continuously for 20-30minutes and will be expressed per gait cycle). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04877249, which also lists 1 linked publication.
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 11 Apr 2025.