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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06304519
• Other study ID #: 1986626-1
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: March 2024
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Dynamic ankle-foot orthosis
customized, carbon fiber, passive ankle-foot orthosis

Locations

Country	Name	City	State
United States	University of Delaware STAR Campus	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical Cost of Transport of the Lower Extremities		Day 2
Primary	Sagittal plane ankle moment during stance		Day 2
Primary	Sagittal plane ankle angle during stance		Day 2
Primary	Self-selected walking speed		Day 2
Primary	a candidate set of clinical outcome measures		Day 2