Ischemic StrokePSRNCT06727097
Post-Stroke Sensory Reweighting on Walking and Balance Outcomes
An observational study of Ischemic Stroke, run by University of Cincinnati at 1 site in United States.
Trial summary
The primary objective of this proof-of-concept study is to longitudinally track the development of post-stroke sensory reweighting (PSR), identify associated structural neuroanatomical correlates, and investigate their relationship to walking and fall outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Posturography, Walking Speed and Instrumented 7M Timed UP and GO
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 30 Aug 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ischemic Stroke (unilateral, Supratentorial)
Who may be able to join
- First ever clinical stroke
- Stroke due to ischemia
- Age 18 years or older
- Ability to consent by patient (not surrogate), any time prior to acute hospital discharge
Who cannot join
- Pre-stroke dependence (modified Rankin Scale score of 3 or more)
- Isolated brainstem or cerebellar stroke
- Bilateral acute strokes
- Co-enrollment in a trial of an intervention through six-month follow-up
- Inability to maintain follow-up with study procedures through six-month follow-up
- Contraindication to non-contrast MRI
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- Low likelihood of survival beyond the acute hospitalization, such as malignant cerebral edema
- Pre-existing co-morbid conditions that significantly affects vision, somatosensory function, vestibular system, orthostasis, coordination or mobility
- Post stroke mRS>4 or discharge to hospice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
Oluwole O Awosika, MD,MSCR, 310-386-0149, oluwole.awosika@uc.edu
About this study
Official title: Tracking the Development and Influence of Post-Stroke Sensory Reweighting on Walking and Balance Outcomes
The primary objective of this proof-of-concept study is to longitudinally track the development of post-stroke sensory reweighting (PSR), identify associated structural neuroanatomical correlates, and investigate their relationship to walking and fall outcomes.
Read the detailed description
Post-stroke imbalance and walking impairment is a function of diminished sensorimotor integration, motor, and postural control. It impacts over 75% of stroke survivors, and remain a rising cause of falls, fractures, and death in the United States. The associated fear of falling often leads to a downward spiral of health, characterized by reduced walking performance, caregiver dependency, social isolation, and the development of secondary post-stroke medical complications. Although spontaneous biological recovery and intensive clinical rehabilitation may improve balance and walking ability, the extent of recovery is often limited after the first 6-months of stroke (chronic phase). Furthermore, currently available clinical measures such as the Berg Balance Scale and Timed-Up-and-Go lack the specificity and granularity needed to foster the development of individualized and targeted neurorehabilitation interventions. In addition, non-invasive neurostimulation strategies lack specificity due to limited understanding of the most appropriate neuroanatomical targets for optimizing sensorimotor integration. Hence there is an urgent need to identify reliable physiologic and neuroanatomic correlates in the earlier stages of recovery (<6 months), to enable timely and targeted rehabilitation interventions.
- Conditions
- Ischemic Stroke
- Being tested
- Posturography, Walking Speed, Instrumented 7M Timed UP and GO, Fall Event Records, MRI (3T)
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PosturographyDiagnostic test
Also called mCITSIB
Successful completion of all four indices of the mCTSIB, without severe imbalance (i.e., near fall with safety harness and urgent knee to grab emergency handlebars) constitutes "PSR +", non-completing on any of the index is noted as "PSR -". Exploratorily, the average sway velocity index will be captured for each condition, to characterize sensory reweighting patterns.
Walking SpeedDiagnostic test
Also called 10 Meter Walk Test
The 10-meter walk test (10MWT) is the gold standard measure of post-stroke walking function that reflects overall mobility and health status. Method: Two 10MWT trials (using a stopwatch) are averaged and documented in meters/second. The functional ambulatory category (FAC) will be collected as supplement. Exploratorily: Participants will also perform the 10mWT (fast paced-FP) with two attempts. Both SS and FP will be performed over the Zeno Walkway Gait Analysis Mat, to capture supplementary spatiotemporal data.
Instrumented 7M Timed UP and GODiagnostic test
Also called iTUG
This sub-aim will use iTUG to determine the effects of BLT on dynamic balance. In contrast to the traditional TUG, inclusion of wearable triaxial accelerometers and gyroscopes-placement test increases the sensitivity (87%) and specificity (87%) for identifying individuals prone to falls. Two trials are averaged and documented in seconds. Secondary analysis will be performed on data obtained from the sensors to determine (stride length, stride velocity, cadence, peak arm swing velocity, and turning velocity, during the task), to correlate with the TUG time/speed. Time points: Same as Posturography and 10 MWT.
Fall Event RecordsOther
A robust fall incident journal elucidating the date, time, nature, and management of the fall event will be provided to all study participants for documentation. The study research coordinator will contact the patient/caregiver/facility to collect the data q2 weeks. A tally of the total number of fall events between visits will be recorded.
MRI (3T)Diagnostic test
Structural neuroimaging biomarkers:. The fractional anisotropy map from the primary fiber population in each voxel will be resampled to MNI space (using the warp derived from structural preprocessing) and projected onto a template white matter skeleton using local maxima to further optimize registration accuracy. Small vessel disease parameters, including white matter hyperintensities using the Fazekas scale and number/site of microhemorrhages, will be recorded for exploratory analyses.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Survivors | First ever clinical stroke (ischemic, supratentorial, and unilateral) Receives: Diagnostic Test: Posturography; Diagnostic Test: Walking Speed; Diagnostic Test: Instrumented 7M Timed UP and GO; Other: Fall Event Records; Diagnostic Test: MRI (3T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posturography
MCTSIB
Measured: 2, 4, and 6 months Post-Stroke
Walking Speed (10 meter Walk Test)
Self-Selected
Measured: 2, 4, and 6 months Post-Stroke
Instrumented Timed UP and GO
7M ITUG
Measured: 2, 4, and 6 months Post-Stroke
Fall Events
Record and characterization of Falls
Measured: 2, 4, and 6 months Post-Stroke
Secondary outcomes (2)
Functional Ambulation Category
Determination of walking status
Measured: 2, 4, and 6 months Post-Stroke
Walking Speed (10 meter Walk Test)
Fastest Speed
Measured: Walking Speed (10 meter Walk Test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Nov 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Oluwole Awosika, University of Cincinnati
- Investigators
- Oluwole Awosika, MD, MSCR, Principal investigator, University of
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727097
- Sponsor's protocol ID
- 2024-0585
- Other IDs
- 1R21HD115776-01
- Acronym
- PSR
- Status last verified
- Aug 2026
- First submitted
- 6 Dec 2024
- Last updated
- 2 Sep 2026
- 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking the Development and Influence of Post-Stroke Sensory Reweighting on Walking and Balance Outcomes
- ClinicalTrials.gov ID
- NCT06727097
- Acronym / sponsor ID
- PSR / 2024-0585
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 10 Dec 2024 (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 primary objective of this proof-of-concept study is to longitudinally track the development of post-stroke sensory reweighting (PSR), identify associated structural neuroanatomical correlates, and investigate their relationship to walking and fall outcomes.
Detailed description
Post-stroke imbalance and walking impairment is a function of diminished sensorimotor integration, motor, and postural control. It impacts over 75% of stroke survivors, and remain a rising cause of falls, fractures, and death in the United States. The associated fear of falling often leads to a downward spiral of health, characterized by reduced walking performance, caregiver dependency, social isolation, and the development of secondary post-stroke medical complications. Although spontaneous biological recovery and intensive clinical rehabilitation may improve balance and walking ability, the extent of recovery is often limited after the first 6-months of stroke (chronic phase). Furthermore, currently available clinical measures such as the Berg Balance Scale and Timed-Up-and-Go lack the specificity and granularity needed to foster the development of individualized and targeted neurorehabilitation interventions. In addition, non-invasive neurostimulation strategies lack specificity due to limited understanding of the most appropriate neuroanatomical targets for optimizing sensorimotor integration. Hence there is an urgent need to identify reliable physiologic and neuroanatomic correlates in the earlier stages of recovery (<6 months), to enable timely and targeted rehabilitation interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke Survivors | – | Diagnostic Test: Posturography, Diagnostic Test: Walking Speed, Diagnostic Test: Instrumented 7M Timed UP and GO, Other: Fall Event Records, Diagnostic Test: MRI (3T)First ever clinical stroke (ischemic, supratentorial, and unilateral) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemic Stroke (unilateral, Supratentorial)
Key inclusion criteria (4 listed)
- First ever clinical stroke
- Stroke due to ischemia
- Age 18 years or older
- Ability to consent by patient (not surrogate), any time prior to acute hospital discharge
Key exclusion criteria (9 listed)
- Pre-stroke dependence (modified Rankin Scale score of 3 or more)
- Isolated brainstem or cerebellar stroke
- Bilateral acute strokes
- Co-enrollment in a trial of an intervention through six-month follow-up
- Inability to maintain follow-up with study procedures through six-month follow-up
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 |
|---|---|---|
| PosturographyAlso: mCITSIBSuccessful completion of all four indices of the mCTSIB, without severe imbalance (i.e., near fall with safety harness and urgent knee to grab emergency handlebars) constitutes "PSR +", non-completing on any of the index is noted as "PSR -". Exploratorily, the average sway velocity index will be captured for each condition, to characterize sensory reweighting patterns. | Diagnostic test | Stroke Survivors |
| Walking SpeedAlso: 10 Meter Walk TestThe 10-meter walk test (10MWT) is the gold standard measure of post-stroke walking function that reflects overall mobility and health status. Method: Two 10MWT trials (using a stopwatch) are averaged and documented in meters/second. The functional ambulatory category (FAC) will be collected as supplement. Exploratorily: Participants will also perform the 10mWT (fast paced-FP) with two attempts. Both SS and FP will be performed over the Zeno Walkway Gait Analysis Mat, to capture supplementary spatiotemporal data. | Diagnostic test | Stroke Survivors |
| Instrumented 7M Timed UP and GOAlso: iTUGThis sub-aim will use iTUG to determine the effects of BLT on dynamic balance. In contrast to the traditional TUG, inclusion of wearable triaxial accelerometers and gyroscopes-placement test increases the sensitivity (87%) and specificity (87%) for identifying individuals prone to falls. Two trials are averaged and documented in seconds. Secondary analysis will be performed on data obtained from the sensors to determine (stride length, stride velocity, cadence, peak arm swing velocity, and turning velocity, during the task), to correlate with the TUG time/speed. Time points: Same as Posturography and 10 MWT. | Diagnostic test | Stroke Survivors |
| Fall Event RecordsA robust fall incident journal elucidating the date, time, nature, and management of the fall event will be provided to all study participants for documentation. The study research coordinator will contact the patient/caregiver/facility to collect the data q2 weeks. A tally of the total number of fall events between visits will be recorded. | Other | Stroke Survivors |
| MRI (3T)Structural neuroimaging biomarkers:. The fractional anisotropy map from the primary fiber population in each voxel will be resampled to MNI space (using the warp derived from structural preprocessing) and projected onto a template white matter skeleton using local maxima to further optimize registration accuracy. Small vessel disease parameters, including white matter hyperintensities using the Fazekas scale and number/site of microhemorrhages, will be recorded for exploratory analyses. | Diagnostic test | Stroke Survivors |
Primary outcome
Posturography
Time frame: 2, 4, and 6 months Post-Stroke
MCTSIB
Walking Speed (10 meter Walk Test)
Time frame: 2, 4, and 6 months Post-Stroke
Self-Selected
Instrumented Timed UP and GO
Time frame: 2, 4, and 6 months Post-Stroke
7M ITUG
Fall Events
Time frame: 2, 4, and 6 months Post-Stroke
Record and characterization of Falls
2 secondary outcomes
Functional Ambulation Category
Time frame: 2, 4, and 6 months Post-Stroke
Walking Speed (10 meter Walk Test)
Time frame: Walking Speed (10 meter Walk Test)
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 2 Sep 2026.
- 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.
Oluwole Awosika, MD, MSCR principal investigator
University of
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by University of Cincinnati 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 4 inclusion and 9 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 2 Sep 2026. 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?
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 oluwole Awosika, MD, MSCR (+1 513 558 2919, awosikoe@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posturography (time frame: 2, 4, and 6 months Post-Stroke). 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?
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 2 Sep 2026.