Post-Stroke Sensory Reweighting on Walking and Balance Outcomes

Last updated: December 6, 2024
Sponsor: University of Cincinnati
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Stroke

Blood Clots

Treatment

Instrumented 7M Timed UP and GO

MRI (3T)

Fall Event Records

Clinical Study ID

NCT06727097
2024-0585
1R21HD115776-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 hospitaldischarge

Exclusion

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 malignantcerebral edema

  8. Pre-existing co-morbid conditions that significantly affects vision, somatosensoryfunction, vestibular system, orthostasis, coordination or mobility

  9. Post stroke mRS>4 or discharge to hospice

Study Design

Total Participants: 45
Treatment Group(s): 5
Primary Treatment: Instrumented 7M Timed UP and GO
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
August 30, 2026

Study 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.

Connect with a study center

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

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