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NCT Number: NCT04619043

Understanding the Effects of Quantitatively-Prescribing Passive-Dynamic Ankle-Foot Orthosis Bending Stiffness for Individuals Post-Stroke

When people walk, their ankle joints help to hold them upright and move them forward. Ankle braces are often given to people who have had a stroke to help their ankle joints work properly. The investigators have developed a method to design and make a special type of ankle brace that allows the investigators to control every characteristic of the ankle brace, allowing the investigators to customize the ankle brace to fit and function just the way the investigators want it to. The investigators think that ankle braces customized to meet the needs of each individual person will help the participants walk better. The investigators have also developed a prescription model that tells the investigators how to customize these ankle braces to address different levels of two common impairments experienced by people post stroke -decreased ability to move the ankle joint and weakened calf muscles. The purpose of this study is to test the prescription model to see if wearing the ankle brace customized based on the prescription model improves people's ability to walk. To accomplish this goal, the investigators will first measure each person's ability to move his/her ankle joint and the strength of his/her calf muscles. The investigators will put this information in to the prescription model to determine how to customize the ankle brace for each person. The investigators will then use the method developed to make the customized ankle brace. Finally, the investigators will measure how each person walks in the ankle brace customized just for the participants. This study will allow the investigators to validate and/or refine the prescription model and teach the investigators how persons post-stroke adapt to walking in ankle braces with different characteristics.

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Key information

Conditions

Gait, Hemiplegic Gait Disorders, Neurologic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

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

  • 21-85 years of age
  • chronic hemiparesis stroke (> 6 months post stroke)
  • prescribed an AFO by a clinician
  • able to walk for at least two minutes without assistance from another person
  • adequate paretic dorsiflexion range-of-motion (RoM ≥ 12°)
  • plantar flexor strength deficits (peak paretic plantar flexion moment in gait at least 0.15 Nm/kg lower than the mean speed-matched, height normalized value from our normative database)

Exclusion criteria

  • cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements)
  • neurologic conditions other than stroke
  • more than one stroke
  • sensorimotor neglect
  • intermittent claudication
  • inability to walk outside the home prior to the stroke
  • total joint replacement and orthopedic problems in the lower limbs or spine that limit walking
  • coronary artery bypass graft or myocardial infarction within past 3 months
  • unexplained dizziness in last 6 months
  • cannot understand spoken instruction, communicate with the investigators
  • walk for 2 minutes at a self-selected speed without assistance from another person (assistive device allowed)
  • must have a resting heart rate between 40-100 beats per minute and a resting blood pressure between 90/60 to 170/90.

Treatment and study plan

Ankle Orthotic

Device

Primary outcomes

  1. Peak Plantar Flexion Moment

    Time frame: 4 weeks

    The peak plantar flexion moment (Newton - meters per degree) will be measured at 0, 2, and 4 weeks via an instrumented gait analysis while the participant walks at their self-selected walking speed wearing their ankle brace.

  2. Step Length

    Time frame: 4 weeks

    Step Length (meters) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.

  3. Step Ratio

    Time frame: 4 weeks

    Step ratio (unitless) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.

  4. Propulsion Impulse Ratio

    Time frame: 4 weeks

    Propulsion Impulse Ratio (unitless) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.

  5. Ankle Power

    Time frame: 4 weeks

    Ankle Power (Work) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.

  6. Propulsion Force

    Time frame: 4 weeks

    Propulsion Force (Newtons) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

Evaluation of a Prescription Model to Customize Passive-Dynamic Ankle-Foot Orthoses for Persons Post-Stroke

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Nov 6, 2020
Registry last updated
Sep 15, 2023

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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