Post-Stroke Sensory Reweighting on Walking and Balance Outcomes

Recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT06727097
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Walking Speed (10 meter Walk Test)	2, 4, and 6 months Post-Stroke	Self-Selected
Instrumented Timed UP and GO	2, 4, and 6 months Post-Stroke	7M ITUG
Posturography	2, 4, and 6 months Post-Stroke	MCTSIB
Fall Events	2, 4, and 6 months Post-Stroke	Record and characterization of Falls

Secondary Outcome Measures

Name	Time	Method
Functional Ambulation Category	2, 4, and 6 months Post-Stroke	Determination of walking status
Walking Speed (10 meter Walk Test)	Walking Speed (10 meter Walk Test)	Fastest Speed

Trial Locations

Locations (1)

University of Cincinnati College of Medicine; 🇺🇸 Cincinnati, Ohio, United States