Post-Stroke Sensory Reweighting on Walking and Balance Outcomes

NCT ID: NCT06727097

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-08-30

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.

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stroke Survivors

First ever clinical stroke (ischemic, supratentorial, and unilateral)

Posturography

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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 spatiotemporal data.

Intervention Type: 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 turning velocity, during the task), to correlate with the TUG time/speed. Time points: Same as Posturography and 10 MWT.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: OTHER

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

mCITSIB; 10 Meter Walk Test; iTUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Oluwole Awosika

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oluwole Awosika, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

University of

Locations

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

oluwole Awosika, MD, MSCR

Role: CONTACT

Phone: +1 513 558 2919

Email: awosikoe@ucmail.uc.edu

Colin Drury, MS

Role: CONTACT

Phone: 513 558 7656

Email: drurycd@ucmail.uc.edu

Facility Contacts

Oluwole O Awosika, MD,MSCR

Role: primary

Other Identifiers

1R21HD115776-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024-0585

Identifier Type: -

Identifier Source: org_study_id