Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of Participants Adhering to the Intervention
研究概览
简要总结
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:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
结局指标
主要结局
Percentage of Participants Adhering to the Intervention
时间窗: From baseline assessment to completion of the 10 week intervention.
Adherence refers to the commitment of a participant to participate in the rehab. Adherence will be measured by calculating the number of rehab sessions attended divided by the number of rehab sessions possible.
Percentage of Treatment That is Able to be Delivered (Fidelity)
时间窗: From baseline assessment to completion of the 10 week intervention.
Fidelity refers to the ability to perform the protocol as intended and that the participants receive the intended treatment as designed. It will be calculated as the number of deviations from protocol divided by the number of treatment sessions.
Percentage of Participants Completing the Intervention (Retention)
时间窗: From baseline assessment to completion of the 10 week intervention.
This will be calculated as the number of participants completing each intervention divided by the number of participants who start each intervention.
Percentage of Participants Who Find the Program Acceptable/Satisfactory
时间窗: From baseline assessment to completion of the 10 week intervention.
A participant satisfaction survey will be utilized to evaluate each rehabilitation protocol, care given, and rehab facility procedures. Scores will range from 1 to 5 with 1 indicating poor performance of the facility and care received versus 5 indicating excellent performance of the facility and care received.
Change in Isometric Ankle Plantar Flexor Muscle Power
时间窗: Baseline assessment and post intervention visit (10-12 weeks following baseline)
Will be assessed isotonically on a dynamometer as the change in peak power from baseline to post-intervention follow-up
Change in Ankle Joint Power During Gait
时间窗: Baseline and post intervention (10-12 weeks following baseline)
Ankle joint power measured with 3D motion capture during walking
Change in Ankle Rate of Torque Development (Ankle RTD)
时间窗: Baseline assessment and post intervention visit (10-12 weeks following baseline)
Will be assessed isometrically on a dynamometer as the change between baseline and post-intervention follow-up. Ankle RTD is calculated as the initial slope of the generated force curve, measured in Newton meters per second.
Change in Ankle Joint Power During Stairs (step up and down)
时间窗: Baseline and post intervention (10-12 weeks following baseline)
Ankle joint power measured with 3D motion capture while climbing stairs
次要结局
- Change in Usual Gait Speed(Baseline and post intervention (10-12 weeks following baseline))
- Change in Fastest Gait Speed(Baseline and following completion of the intervention (10-12 weeks post baseline visit))
- Change in 11 Stair Climb Test Score(Baseline visit and post intervention visit (10-12 weeks post baseline))
- Change in Ankle fracture outcome rehabilitation measure (A-FORM)(Baseline and post intervention (10-12 weeks following baseline))
- Change in PROMIS Physical Function Computer Adaptive Test(Baseline assessment and post intervention visit (10-12 weeks later))
研究者
Brian W. Noehren
Associate Dean
University of Kentucky