Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis

Официальное название

Individualizing Powered Orthotic Intervention for Improved Gait Outcomes Using ML-enabled Methods

Обзор

The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in adults who have had a lower limb injury.

Подробное описание

The long-term goal of this project is to improve the outcomes of robot-assisted exercise interventions for patients with reconstructed lower limb following high-energy lower extremity traumas using novel machine learning methods to enable individualized ankle foot orthosis (AFO) designs and self-adaptive AFO assistance.

The main hypothesis predicts greater comfort and lower pain levels when using the new AFO as well as improvements in gait mechanics, which will outperform those induced by patients' daily-use AFOs. The main goal is this adaptive assistance will encourage the wearer's active engagement in RAGT thereby promoting patient self-efficacy/satisfaction and leading to improvements in ambulation after a 6-week rehabilitation program.

Вмешательства

• Устройство Utilization of motorized orthosis
  While part of this study, participants will be fitted for the motorized orthosis and will complete walking tests with and without the AFO.

Первичные конечные точки

• 10MWT (Aim 1) [Срок оценки: Measured before and after 6 week intervention to assess change from baseline.]
• TUG (Aim 1) [Срок оценки: Measured before and after 6 week intervention to assess change from baseline.]
• 6MWT (Aim 1) [Срок оценки: Measured before and after 6 week intervention to assess change from baseline.]

Критерии участия

Критерии включения

• Have a lower limb injury greater than a year ago.
• Be 18-80 years old.
• Be able to stand for 30 minutes.
• Have enough range of motion in my ankle to comfortably wear the AFO.
• Be able to follow directions and commands.
• Be willing and able to give informed consent.
• Be able and willing to comply with study procedures, verbal instructions, and follow-up requirements.

Критерии исключения

• Have any joint or muscle tightness that would limit my movement while walking with the AFO.
• Have any medical issue that prevents me from supporting my weight and walking (e.g. orthopedic injuries, pain, severe spasticity).
• Have any medical issues that affect my unaffected side.
• Have skin issues that would prevent wearing the device.
• Have a pre-existing condition that caused exercise intolerance. (Documented uncontrolled hypertension, coronary artery disease, abnormal heart rate or rhythm, or congestive heart failure).
• Have been hospitalized for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
• Have nervous system issues that affect my movement (for example Parkinson's disease, multiple sclerosis).
• Have additional orthopedic issues that interfere with my walking or limit my range of motion in my legs.
• Have any other medical conditions that my doctor or physical therapist feels would affect my ability to use the device.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Kessler Foundation — West Orange

Идентификаторы

NCT: NCT06923293 · D-1182-22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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