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NCT Number: NCT06727097

Post-Stroke Sensory Reweighting on Walking and Balance Outcomes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

Location status: Recruiting

Location contact

Oluwole O Awosika, MD,MSCR

CONTACT

[email protected]

3103860149

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: mCITSIB

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.

Other names: 10 Meter Walk Test

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.

Other names: iTUG

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.

Primary outcomes

  1. Posturography

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

    MCTSIB

  2. Walking Speed (10 meter Walk Test)

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

    Self-Selected

  3. Instrumented Timed UP and GO

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

    7M ITUG

  4. Fall Events

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

    Record and characterization of Falls

Secondary outcomes

  1. Functional Ambulation Category

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

    Determination of walking status

  2. Walking Speed (10 meter Walk Test)

    Time frame: Walking Speed (10 meter Walk Test)

    Fastest Speed

Study contacts

Contact information is provided by the study sponsor or research team.

Colin Drury, MS

CONTACT

[email protected]

513 558 7656

oluwole Awosika, MD, MSCR

CONTACT

[email protected]

+1 513 558 2919

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

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

Registry information

Official study title

Tracking the Development and Influence of Post-Stroke Sensory Reweighting on Walking and Balance Outcomes

Acronym: PSR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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