Clinical trial NCT06727097: Post-Stroke Sensory Reweighting on Walking and Balance Outcomes
Official title: Tracking the Development and Influence of Post-Stroke Sensory Reweighting on Walking and Balance Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-12-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ischemic Stroke (unilateral, Supratentorial)

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.

Detailed description: Post-stroke imbalance and walking impairment is a function of diminished sensorimotor integration, motor, and postural control. It impacts over 75% of stroke survivors, and remain a rising cause of falls, fractures, and death in the United States. The associated fear of falling often leads to a downward spiral of health, characterized by reduced walking performance, caregiver dependency, social isolation, and the development of secondary post-stroke medical complications. Although spontaneous biological recovery and intensive clinical rehabilitation may improve balance and walking ability, the extent of recovery is often limited after the first 6-months of stroke (chronic phase). Furthermore, currently available clinical measures such as the Berg Balance Scale and Timed-Up-and-Go lack the specificity and granularity needed to foster the development of individualized and targeted neurorehabilitation interventions. In addition, non-invasive neurostimulation strategies lack specificity due to limited understanding of the most appropriate neuroanatomical targets for optimizing sensorimotor integration. Hence there is an urgent need to identify reliable physiologic and neuroanatomic correlates in the earlier stages of recovery (\<6 months), to enable timely and targeted rehabilitation interventions.

Eligibility criteria: Inclusion Criteria:

1. First ever clinical stroke
2. Stroke due to ischemia
3. Age 18 years or older
4. Ability to consent by patient (not surrogate), any time prior to acute hospital discharge

Exclusion Criteria:

1. Pre-stroke dependence (modified Rankin Scale score of 3 or more)
2. Isolated brainstem or cerebellar stroke
3. Bilateral acute strokes
4. Co-enrollment in a trial of an intervention through six-month follow-up
5. Inability to maintain follow-up with study procedures through six-month follow-up
6. Contraindication to non-contrast MRI
7. Low likelihood of survival beyond the acute hospitalization, such as malignant cerebral edema
8. Pre-existing co-morbid conditions that significantly affects vision, somatosensory function, vestibular system, orthostasis, coordination or mobility
9. Post stroke mRS\>4 or discharge to hospice

Primary outcomes:
measure: Posturography
timeFrame: 2, 4, and 6 months Post-Stroke
measure: Walking Speed (10 meter Walk Test)
timeFrame: 2, 4, and 6 months Post-Stroke
measure: Instrumented Timed UP and GO
timeFrame: 2, 4, and 6 months Post-Stroke
measure: Fall Events
timeFrame: 2, 4, and 6 months Post-Stroke
Secondary outcomes:
measure: Functional Ambulation Category
timeFrame: 2, 4, and 6 months Post-Stroke
measure: Walking Speed (10 meter Walk Test)
timeFrame: Walking Speed (10 meter Walk Test)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
Study officials:
affiliation: University of
name: Oluwole Awosika, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References: