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

Overview

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.

Interventions

• Diagnostic test Posturography
  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.
• Diagnostic test Walking Speed
  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 spa
• Diagnostic test Instrumented 7M Timed UP and GO
  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 turni
• Other Fall Event Records
  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.
• Diagnostic test MRI (3T)
  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.

Primary outcome measures

• Posturography [Time frame: 2, 4, and 6 months Post-Stroke]
• Walking Speed (10 meter Walk Test) [Time frame: 2, 4, and 6 months Post-Stroke]
• Instrumented Timed UP and GO [Time frame: 2, 4, and 6 months Post-Stroke]
• Fall Events [Time frame: 2, 4, and 6 months Post-Stroke]

Secondary outcome measures (2)

• Functional Ambulation Category [Time frame: 2, 4, and 6 months Post-Stroke]
• Walking Speed (10 meter Walk Test) [Time frame: Walking Speed (10 meter Walk Test)]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• University of Cincinnati College of Medicine — Cincinnati

Identifiers

NCT: NCT06727097 · 2024-0585 · 1R21HD115776-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗