Post-Stroke Sensory Reweighting on Walking and Balance Outcomes

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT06727097
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
    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 Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Dec 2024
Primary completion
Aug 30, 2026
Completion
Aug 30, 2026

Study Design

Enrollment
45 participants (estimated)

Arms

  • Arm: Stroke Survivors
    First ever clinical stroke (ischemic, supratentorial, and unilateral)

Primary Outcome Measure

Posturography [ Time Frame: 2, 4, and 6 months Post-Stroke ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Cincinnati College of MedicineCincinnatiOhio45267
Oluwole O Awosika, MD,MSCR
[email protected]
3103860149

Find similar trials in Cincinnati, OH

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Cincinnati College of Medicine· Cincinnati, OH

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