About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Ischemic Stroke (unilateral, Supratentorial)
Trial design
Cohort
Prospective
Treatments tested in this trial
Posturography
Diagnostic testSuccessful 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
Diagnostic 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.
Instrumented 7M Timed UP and GO
Diagnostic testThis 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
Other interventionA 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 testStructural 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.
Treatment groups
Trial outcomes
Primary outcomes
Posturography
MCTSIB
Walking Speed (10 meter Walk Test)
Self-Selected
Instrumented Timed UP and GO
7M ITUG
Fall Events
Record and characterization of Falls
Secondary outcomes
Functional Ambulation Category
Determination of walking status
Walking Speed (10 meter Walk Test)
Fastest Speed
Sponsors and contacts
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University of Cincinnati
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator