Post-Stroke Sensory Reweighting on Walking and Balance Outcomes
PSR
Tracking the Development and Influence of Post-Stroke Sensory Reweighting on Walking and Balance Outcomes
2 other identifiers
observational
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2024
CompletedFirst Submitted
Initial submission to the registry
December 6, 2024
CompletedFirst Posted
Study publicly available on registry
December 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2026
December 10, 2024
December 1, 2024
1.8 years
December 6, 2024
December 6, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Posturography
MCTSIB
2, 4, and 6 months Post-Stroke
Walking Speed (10 meter Walk Test)
Self-Selected
2, 4, and 6 months Post-Stroke
Instrumented Timed UP and GO
7M ITUG
2, 4, and 6 months Post-Stroke
Fall Events
Record and characterization of Falls
2, 4, and 6 months Post-Stroke
Secondary Outcomes (2)
Functional Ambulation Category
2, 4, and 6 months Post-Stroke
Walking Speed (10 meter Walk Test)
Walking Speed (10 meter Walk Test)
Study Arms (1)
Stroke Survivors
First ever clinical stroke (ischemic, supratentorial, and unilateral)
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
Ischemic Stroke (unilateral, Supratentorial)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oluwole Awosika, MD, MSCR
University of
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 6, 2024
First Posted
December 10, 2024
Study Start
November 1, 2024
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
August 30, 2026
Last Updated
December 10, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share