Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture

Обзор

The goal of this clinical trial is to compare two different standardized physical therapy rehabilitation programs on outcomes after an ankle fracture. Researchers will evaluate to see if the addition of ankle muscle power exercises (AMP) improve program adherence, muscle function, physical performance, and patient reported outcomes. The main questions it aims to answer are: 1. Assess feasibility and define the initial effects of the AMP program on ankle plantar flexor rate of torque development and ankle power. Primary hypothesis: an ankle muscle power program will have acceptable feasibility through assessment of 80% adherence, 90% treatment fidelity, recruitment (48 participants who complete the study), 80% retention, and 80% acceptability of the AMP program to facilitate clinical translation and the ability to scale-up the treatment. In addition ankle plantar flexor muscle power, plantar flexor RTD assessed isometrically, and ankle joint power, evaluated during gait and stair ascent/descent, will have significantly greater improvements in the AMP group than the standard of care group at the end of the intervention. 2. Test the effect of the AMP program on physical performance. Primary hypothesis: those completing the AMP program will have greater improvements in the 40 meter fast paced walk test and 11-stair climb test than those completing standard of care at the completion of the intervention. 3. Assess the preliminary efficacy of the AMP program on patient reported outcomes and quality of life. Primary hypothesis: compared to standard of care, the AMP program will result in improved quality of life on the ankle fracture outcome rehabilitation measure (A-FORM) Participants will complete rehabilitation and be assessed for outcomes at baseline and after completing the intervention. Additionally exploratory outcomes will be assessed 3 months after completing the intervention.

Вмешательства

• Другое Ankle Muscle Power (AMP) program
  The AMP program targets various aspects of muscle power development through a program that takes the participant through 3 different stages of training over the course of their rehabilitation. This portion of the program is in addition to receiving standard rehabilitation exercises as well.
• Поведенческое Standard of Care
  Standard rehabilitation program

Первичные конечные точки

• Percentage of Participants Adhering to the Intervention [Срок оценки: From baseline assessment to completion of the 10 week intervention.]
• Percentage of Treatment That is Able to be Delivered (Fidelity) [Срок оценки: From baseline assessment to completion of the 10 week intervention.]
• Percentage of Participants Completing the Intervention (Retention) [Срок оценки: From baseline assessment to completion of the 10 week intervention.]
• Percentage of Participants Who Find the Program Acceptable/Satisfactory [Срок оценки: From baseline assessment to completion of the 10 week intervention.]
• Change in Isometric Ankle Plantar Flexor Muscle Power [Срок оценки: Baseline assessment and post intervention visit (10-12 weeks following baseline)]
• Change in Ankle Rate of Torque Development (Ankle RTD) [Срок оценки: Baseline assessment and post intervention visit (10-12 weeks following baseline)]
• Change in Ankle Joint Power During Gait [Срок оценки: Baseline and post intervention (10-12 weeks following baseline)]
• Change in Ankle Joint Power During Stairs (step up and down) [Срок оценки: Baseline and post intervention (10-12 weeks following baseline)]

Вторичные конечные точки (5)

• Change in Usual Gait Speed [Срок оценки: Baseline and post intervention (10-12 weeks following baseline)]
• Change in Fastest Gait Speed [Срок оценки: Baseline and following completion of the intervention (10-12 weeks post baseline visit)]
• Change in 11 Stair Climb Test Score [Срок оценки: Baseline visit and post intervention visit (10-12 weeks post baseline)]
• Change in Ankle fracture outcome rehabilitation measure (A-FORM) [Срок оценки: Baseline and post intervention (10-12 weeks following baseline)]
• Change in PROMIS Physical Function Computer Adaptive Test [Срок оценки: Baseline assessment and post intervention visit (10-12 weeks later)]

Критерии участия

Критерии включения

• Age 18-50 years old
• Acute orthopedic injury to the ankle requiring surgical fixation
• Must have stable address and phone number to schedule follow up contact visits
• English speaking
• BMI ≤ 35 kg/m2

Критерии исключения

• History of chronic pain defined as pain lasting more than 3 months and bothersome at least half the days over the past 6 months that started before the fracture
• Moderate or severe traumatic brain injury
• Initial treatment requiring amputation
• Spinal cord injury
• Unable to speak or read English
• History of schizophrenia, dementia, neurologic disorder with peripheral dysfunction, or other psychotic disorder based upon medical record or patient self-report
• Any chronic conditions that would limit their ability to participate in an intervention
• Multiple trauma that prevents engaging in intervention
• Pregnant
• Unable to participate in or complete in-person follow up visits or therapy sessions
• In Physical Therapy at the start of the intervention.
• Use of an assistive device to walk for community ambulation
• Prior lower extremity fracture within the past 2 years

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Kentucky — Lexington

Идентификаторы

NCT: NCT07173088 · 103812 · HT9425-25-1-0625

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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