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Completed

NCT Number: NCT06304519

Identifying the Optimal Dynamic Ankle-Foot Orthosis Bending Stiffness for Individuals Post-Stroke

Ankle braces are commonly prescribed to individuals who have suffered a stroke to help their ankle joints work properly, which allows these individuals to walk better. Currently, there are no standardized guidelines to follow when choosing which brace is best for an individual. Prior work has shown that customizing the level of assistance that these braces provide based on each individual's level of ankle impairment improves the individuals' walking function more than their current brace. The next important step is to fine-tune the customization and work to develop a set of guidelines that can be used by clinicians to help them prescribe the right brace for each patient's needs. The purpose of this study is to test different levels of assistance provided by the brace to determine the optimal customization method. Additionally, this study aims to begin to create a guide to help clinicians choose the best brace for each individuals' needs. To accomplish this goal, individuals will walk with a brace under five different assistance level conditions. The individual's walking function, performance on clinical measures, and response to questionnaires will be examined to determine both the optimal brace for each individual and hopefully identify clinical tools that can be used to guide prescription of the brace. This study is a major step towards developing effective, standardized prescription guidelines that optimize walking of individuals post-stroke.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware STAR Campus

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • chronic stroke (> 6 months post-stroke)
  • been prescribed an AFO by a clinician
  • have plantar flexor strength deficits (unable to complete at least 25 standing heel-raises
  • have at least 5 degrees of passive dorsiflexion range of motion (as measured during the clinical evaluation in Visit 1).

Exclusion criteria

  • Those that will not be included in this study are individuals with 1) Evidence of cerebellar stroke on clinical MRI, 2) Other neurologic conditions in addition to stroke, 3) Sensorimotor neglect, 4) Inability to walk outside the home prior to the stroke, 5) Total joint replacement or orthopedic problems in the lower limbs or spine that limit walking, 6) Coronary artery bypass graft or myocardial infarction within past 3 months, 7) Unexplained dizziness in last 6 months, 8) Inability to communicate with investigators, 9) Lack of decisional capacity.

Treatment and study plan

Dynamic ankle-foot orthosis

Device

customized, carbon fiber, passive ankle-foot orthosis

Primary outcomes

  1. Mechanical Cost of Transport of the Lower Extremities

    Time frame: Day 2

  2. Sagittal plane ankle moment during stance

    Time frame: Day 2

  3. Sagittal plane ankle angle during stance

    Time frame: Day 2

  4. Self-selected walking speed

    Time frame: Day 2

  5. a candidate set of clinical outcome measures

    Time frame: Day 2

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

Identifying the Optimal Patient-Specific Dynamic Ankle-Foot Orthosis Bending Stiffness in an Evidence-Based Manner That Can be Implemented by Clinical Providers

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
May 4, 2026

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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