RecruitingNCT06727097

Post-Stroke Sensory Reweighting on Walking and Balance Outcomes

Tracking the Development and Influence of Post-Stroke Sensory Reweighting on Walking and Balance Outcomes

Sponsor

University of Cincinnati

Enrollment

45 participants

Start Date

Nov 1, 2024

Study Type

OBSERVATIONAL

Conditions

Ischemic Stroke

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria9

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
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

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Interventions

DIAGNOSTIC_TESTPosturography

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.

DIAGNOSTIC_TESTWalking 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.

DIAGNOSTIC_TESTInstrumented 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.

OTHERFall 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.

DIAGNOSTIC_TESTMRI (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.