Post-Stroke Sensory Reweighting on Walking and Balance Outcomes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Cincinnati

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Posturography

    Diagnostic test

    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

    Diagnostic 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 GO

    Diagnostic test

    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

    Other intervention

    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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Stroke Survivors5 interventions

Trial outcomes

Primary outcomes

1

Posturography

MCTSIB

Time frame
2, 4, and 6 months Post-Stroke
2

Walking Speed (10 meter Walk Test)

Self-Selected

Time frame
2, 4, and 6 months Post-Stroke
3

Instrumented Timed UP and GO

7M ITUG

Time frame
2, 4, and 6 months Post-Stroke
4

Fall Events

Record and characterization of Falls

Time frame
2, 4, and 6 months Post-Stroke

Secondary outcomes

1

Functional Ambulation Category

Determination of walking status

Time frame
2, 4, and 6 months Post-Stroke
2

Walking Speed (10 meter Walk Test)

Fastest Speed

Time frame
Walking Speed (10 meter Walk Test)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cincinnati

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator