StrokeNCT03916562
Optimization Principles in Hemiparetic Gait
A study testing Manipulation of spatiotemporal coordination during walking in people with Stroke, run by University of Southern California at 1 site in United States.
Trial summary
This project seeks to identify the how walking impairments in stroke survivors contribute to mobility deficits through the use of behavioral observations and computational models. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Manipulation of spatiotemporal coordination during walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2018to 30 Nov 2023
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No musculoskeletal injury or conditions that limit walking ability
- No history of neurological disorders or severe head trauma
- Absence of cognitive impairment as demonstrated by a Mini-Mental score greater than 24
- Presence of unilateral brain lesion from a single stroke
- Weakness confined to one side
- Ability to walk on a treadmill for five minutes continuously without a cane or walker
- Absence of cognitive impairment as demonstrated by a Mini-Mental score greater than 24
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90033
James Finley, PhD, 323-442-4837, jmfinley@pt.usc.edu
About this study
Official title: Toward a Mechanistic Understanding of Optimization Principles Underlying Hemiparetic Gait
This project seeks to identify the how walking impairments in stroke survivors contribute to mobility deficits through the use of behavioral observations and computational models. The chosen approach integrates biomechanical analyses, physiological assessments and machine learning algorithms to explain how asymmetries during walking influence balance and the effort required to walk. Ultimately, the results of this work may lead to more personalized rehabilitation strategies to improve walking capacity and efficiency, and ultimately reduce fall risk in stroke survivors.
- Conditions
- Stroke
- Being tested
- Manipulation of spatiotemporal coordination during walking
- Keywords
- Walking, Gait, Stability, Energetic cost
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manipulation of spatiotemporal coordination during walkingBehavioural
A description of the intervention is included in the description of the study arms.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Experimental | The investigators will determine how asymmetric walking constraints influence spatiotemporal coordination, energetic cost, and dynamic balance in healthy individuals. The investigators will manipulate spatiotemporal coordination using a special treadmill. Energetic cost will be quantified using expired gas analysis and inverse dynamic approaches. Stability will be evaluated by characterizing participants' ability to recover from unexpected perturbations. Receives: Behavioral: Manipulation of spatiotemporal coordination during walking |
| Post-stroke Participants | Experimental | The investigators will determine how different patterns of coordination during walking influence energetic cost and dynamic balance in people post-stroke. The investigators will manipulate coordination using a special treadmill. Energetic cost will be quantified using expired gas analysis and inverse dynamic approaches. Stability will be evaluated by characterizing participants' ability to recover from unexpected perturbations. Receives: Behavioral: Manipulation of spatiotemporal coordination during walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption (VO2)
The investigators will use a metabolic cart to measure the rate of oxygen consumption (VO2) while participants walk at a fixed speed on a treadmill.
Measured: At the beginning of study day one
Correlation between oxygen consumption (VO2) and step length asymmetry
The investigators will use a metabolic cart to measure the rate of oxygen consumption (VO2) while participants walk at a fixed speed on a treadmill. VO2 will be measured in five trials where participants walk with different levels of step length asymmetry. This outcome will capture the relationship between measures of VO2 and step length asymmetry.
Measured: During study day one
Angular momentum during walking
Motion capture will be used to measure the kinematics of the body when participants respond to accelerations of the treadmill
Measured: At the beginning of study day two
Correlation between angular momentum and step length asymmetry during walking
Participants will complete five trials at different levels of step length asymmetry. During these trials, motion capture will be used to measure the kinematics of the body when participants respond to accelerations of the treadmill. This outcome measure will use data from all trials to determine the relationship between angular momentum and step length asymmetry.
Measured: During study day two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start13 Nov 2018
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- For this study, the investigators will recruit two separate groups of participants who will complete the study procedures in parallel. One group will be comprised of individuals post-stroke and the second group will be comprised of adults who have not had a stroke.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, James Finley, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916562
- Sponsor's protocol ID
- HS-18-00533
- Other IDs
- R01HD091184
- Status last verified
- May 2023
- First submitted
- 31 Mar 2019
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sanchez N, Finley JM. Individual Differences in Locomotor Function Predict the Capacity to Reduce Asymmetry and Modify the Energetic Cost of Walking Poststroke. Neurorehabil Neural Repair. 2018 Aug;32(8):701-713. doi: 10.1177/1545968318787913. Epub 2018 Jul 12.
PubMed 29998788Liu C, Macedo L, Finley JM. Conservation of Reactive Stabilization Strategies in the Presence of Step Length Asymmetries During Walking. Front Hum Neurosci. 2018 Jun 27;12:251. doi: 10.3389/fnhum.2018.00251. eCollection 2018.
PubMed 29997488Sanchez N, Park S, Finley JM. Evidence of Energetic Optimization during Adaptation Differs for Metabolic, Mechanical, and Perceptual Estimates of Energetic Cost. Sci Rep. 2017 Aug 9;7(1):7682. doi: 10.1038/s41598-017-08147-y.
PubMed 28794494Finley JM, Bastian AJ. Associations Between Foot Placement Asymmetries and Metabolic Cost of Transport in Hemiparetic Gait. Neurorehabil Neural Repair. 2017 Feb;31(2):168-177. doi: 10.1177/1545968316675428. Epub 2016 Oct 22.
PubMed 27798378Finley JM, Long A, Bastian AJ, Torres-Oviedo G. Spatial and Temporal Control Contribute to Step Length Asymmetry During Split-Belt Adaptation and Hemiparetic Gait. Neurorehabil Neural Repair. 2015 Sep;29(8):786-95. doi: 10.1177/1545968314567149. Epub 2015 Jan 14.
PubMed 25589580Park S, Liu C, Sanchez N, Tilson JK, Mulroy SJ, Finley JM. Using Biofeedback to Reduce Step Length Asymmetry Impairs Dynamic Balance in People Poststroke. Neurorehabil Neural Repair. 2021 Aug;35(8):738-749. doi: 10.1177/15459683211019346. Epub 2021 Jun 1.
PubMed 34060926
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward a Mechanistic Understanding of Optimization Principles Underlying Hemiparetic Gait
- ClinicalTrials.gov ID
- NCT03916562
- Acronym / sponsor ID
- HS-18-00533
- Conditions
- Stroke
- Keywords
- Walking, Gait, Stability, Energetic cost
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 16 Apr 2019 (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.
This project seeks to identify the how walking impairments in stroke survivors contribute to mobility deficits through the use of behavioral observations and computational models. The chosen approach integrates biomechanical analyses, physiological assessments and machine learning algorithms to explain how asymmetries during walking influence balance and the effort required to walk. Ultimately, the results of this work may lead to more personalized rehabilitation strategies to improve walking capacity and efficiency, and ultimately reduce fall risk in stroke survivors.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For this study, the investigators will recruit two separate groups of participants who will complete the study procedures in parallel. One group will be comprised of individuals post-stroke and the second group will be comprised of adults who have not had a stroke.
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Experimental | Behavioral: Manipulation of spatiotemporal coordination during walkingThe investigators will determine how asymmetric walking constraints influence spatiotemporal coordination, energetic cost, and dynamic balance in healthy individuals. The investigators will manipulate spatiotemporal coordination using a special treadmill. Energetic cost will be quantified using expired gas analysis and inverse dynamic approaches. Stability will be evaluated by characterizing participants' ability to recover from unexpected perturbations. |
| Post-stroke Participants | Experimental | Behavioral: Manipulation of spatiotemporal coordination during walkingThe investigators will determine how different patterns of coordination during walking influence energetic cost and dynamic balance in people post-stroke. The investigators will manipulate coordination using a special treadmill. Energetic cost will be quantified using expired gas analysis and inverse dynamic approaches. Stability will be evaluated by characterizing participants' ability to recover from unexpected perturbations. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- No musculoskeletal injury or conditions that limit walking ability
- No history of neurological disorders or severe head trauma
- Absence of cognitive impairment as demonstrated by a Mini-Mental score greater than 24
- Presence of unilateral brain lesion from a single stroke
- Weakness confined to one side
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Manipulation of spatiotemporal coordination during walkingA description of the intervention is included in the description of the study arms. | Behavioural | Healthy Participants, Post-stroke Participants |
Primary outcome
Oxygen consumption (VO2)
Time frame: At the beginning of study day one
The investigators will use a metabolic cart to measure the rate of oxygen consumption (VO2) while participants walk at a fixed speed on a treadmill.
Correlation between oxygen consumption (VO2) and step length asymmetry
Time frame: During study day one
The investigators will use a metabolic cart to measure the rate of oxygen consumption (VO2) while participants walk at a fixed speed on a treadmill. VO2 will be measured in five trials where participants walk with different levels of step length asymmetry. This outcome will capture the relationship between measures of VO2 and step length asymmetry.
Angular momentum during walking
Time frame: At the beginning of study day two
Motion capture will be used to measure the kinematics of the body when participants respond to accelerations of the treadmill
Correlation between angular momentum and step length asymmetry during walking
Time frame: During study day two
Participants will complete five trials at different levels of step length asymmetry. During these trials, motion capture will be used to measure the kinematics of the body when participants respond to accelerations of the treadmill. This outcome measure will use data from all trials to determine the relationship between angular momentum and step length asymmetry.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Background: PubMed 29998788Sanchez N, Finley JM. Individual Differences in Locomotor Function Predict the Capacity to Reduce Asymmetry and Modify the Energetic Cost of Walking Poststroke. Neurorehabil Neural Repair. 2018 Aug;32(8):701-713. doi: 10.1177/1545968318787913. Epub 2018 Jul 12.
- Background: PubMed 29997488Liu C, Macedo L, Finley JM. Conservation of Reactive Stabilization Strategies in the Presence of Step Length Asymmetries During Walking. Front Hum Neurosci. 2018 Jun 27;12:251. doi: 10.3389/fnhum.2018.00251. eCollection 2018.
- Background: PubMed 28794494Sanchez N, Park S, Finley JM. Evidence of Energetic Optimization during Adaptation Differs for Metabolic, Mechanical, and Perceptual Estimates of Energetic Cost. Sci Rep. 2017 Aug 9;7(1):7682. doi: 10.1038/s41598-017-08147-y.
- Background: PubMed 27798378Finley JM, Bastian AJ. Associations Between Foot Placement Asymmetries and Metabolic Cost of Transport in Hemiparetic Gait. Neurorehabil Neural Repair. 2017 Feb;31(2):168-177. doi: 10.1177/1545968316675428. Epub 2016 Oct 22.
- Background: PubMed 25589580Finley JM, Long A, Bastian AJ, Torres-Oviedo G. Spatial and Temporal Control Contribute to Step Length Asymmetry During Split-Belt Adaptation and Hemiparetic Gait. Neurorehabil Neural Repair. 2015 Sep;29(8):786-95. doi: 10.1177/1545968314567149. Epub 2015 Jan 14.
- Derived from this study: PubMed 34060926Park S, Liu C, Sanchez N, Tilson JK, Mulroy SJ, Finley JM. Using Biofeedback to Reduce Step Length Asymmetry Impairs Dynamic Balance in People Poststroke. Neurorehabil Neural Repair. 2021 Aug;35(8):738-749. doi: 10.1177/15459683211019346. Epub 2021 Jun 1.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulation of spatiotemporal coordination during walking in people with Stroke, run by University of Southern California 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 7 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 23 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Finley, Ph.D. (3234424837, jmfinley@pt.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption (VO2) (time frame: At the beginning of study day one). The study lists 4 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 NCT03916562, which also lists 6 linked publications.
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 23 May 2023.