Recruiting

Observational Study

Sponsor:

University of Cincinnati

Code:

NCT06727097

Conditions

Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Posturography

Walking Speed

Instrumented 7M Timed UP and GO

Fall Event Records

MRI (3T)

Study Details

Brief 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.

Conditions

Ischemic Stroke

Study ID

NCT06727097

Start date

Nov 1, 2024

Status verified date

Aug, 2026

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. First ever clinical stroke
2. Stroke due to ischemia
3. Age 18 years or older
4. Ability to consent by patient (not surrogate), any time prior to acute hospital discharge

Exclusion Criteria:

1. Pre-stroke dependence (modified Rankin Scale score of 3 or more)
2. Isolated brainstem or cerebellar stroke
3. Bilateral acute strokes
4. Co-enrollment in a trial of an intervention through six-month follow-up
5. Inability to maintain follow-up with study procedures through six-month follow-up
6. Contraindication to non-contrast MRI
7. Low likelihood of survival beyond the acute hospitalization, such as malignant cerebral edema
8. Pre-existing co-morbid conditions that significantly affects vision, somatosensory function, vestibular system, orthostasis, coordination or mobility
9. Post stroke mRS>4 or discharge to hospice

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

Stroke Survivors

First ever clinical stroke (ischemic, supratentorial, and unilateral)

Interventions

Posturography

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 Speed

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 GO

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 Records

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)

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.

Primary outcome measure

  • Posturography [ Time Frame: 2, 4, and 6 months Post-Stroke ]
  • Walking Speed (10 meter Walk Test) [ Time Frame: 2, 4, and 6 months Post-Stroke ]
  • Instrumented Timed UP and GO [ Time Frame: 2, 4, and 6 months Post-Stroke ]
  • Fall Events [ Time Frame: 2, 4, and 6 months Post-Stroke ]

Central Contacts and Locations

Central contacts

oluwole Awosika, MD, MSCR

+1 513 558 2919awosikoe@ucmail.uc.edu

Colin Drury, MS

513 558 7656drurycd@ucmail.uc.edu

Locations

University of Cincinnati College of Medicine

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Oluwole O Awosika, MD,MSCR

310-386-0149oluwole.awosika@uc.edu

More Information

Sponsor

University of Cincinnati

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-09-02.