Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Peak Plantar Force (Midfoot)
研究概览
简要总结
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. Research suggests that ankle arthritis develops after ankle fracture, in part, due to elevated forces on the cartilage. It is expected that carbon fiber braces can be designed to reduce forces in the ankle joint and thereby reduce the risk of developing arthritis following traumatic injury. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The proposed study will provide evidence that can be used by clinicians and researchers to design braces that most effectively reduce forces on ankle cartilage.
详细描述
The primary purpose of this line of research is to investigate the effects of carbon fiber custom dynamic orthosis (CDO) design on the forces and contact stress at the ankle, with the goal of reducing the development of post traumatic osteoarthritis (PTOA) in the ankle. Research suggests that ankle arthritis develops, in part, due to increased contact stresses within the ankle joint following fracture. It is expected that reducing articular contact stress at the ankle has the potential to delay or prevent the development of PTOA. CDOs have been shown to significantly improve function following extremity injury, and show promise for offloading the injured limb after severe lower extremity injuries. Therefore, the proposed effort is designed to evaluate how different CDO design factors influence offloading and therefore the reduction of forces and articular contact stress at the ankle.
Adult participants will be evaluated while wearing carbon fiber braces of varied geometry. The primary dependent measure is ankle joint contact stress. Following consent and enrollment computerized tomography (CT) images will be used to determine the geometry of the joint articular surfaces. Ankle contact stress will be calculated using discrete element analysis and biomechanical data collected in subsequent data collection.
Participants will be cast and fit for three CDOs with varied geometry. Participants will be blinded to the design variation of each device and will only know them as CDO-A, CDO-B, or CDO-C. Testing will be completed under 4 conditions: No-CDO, CDO-A, CDO-B, CDO-C, with each bracing condition (A/B/C) representing a CDO design variant. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that changes to device design do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without CDO use, satisfaction with the devices, perception of comfort and smoothness between devices, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates in the floor. Forces between the foot and CDO will be measured using force sensing insoles, and muscle activity data will be collected using surface electromyography. Devices will be mechanically tested, and participant demographic and anthropometric data will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to the different design variations of each device, and will only be introduced to each device as CDO-A, CDO-B or CDO-C.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •TIBIAL PILON FRACTURE PARTICIPANTS:
- •Inclusion Criteria:
- •Ages: 18-65
- •Sustained unilateral fracture of the tibial pilon within the preceding 5 years
- •The fracture has completely healed
- •Ability to walk 50 feet without use of an assistive device (cane, crutch, etc.)
- •Ability to walk at a slow to moderate pace
- •Shoe size between women's 8 and 13.5 or men's 6.5 and 13
- •Ability to read and write in English and provide written informed consent
- •Individuals with elevated contact stress according to model generated using PedCAT standing CT images (will be answered after completing visit one)
排除标准
- •Pain > 6/10 while walking
- •Increase in pain during testing of 3/10 or greater
- •Neurologic, musculoskeletal (including bilateral fractures) or other condition limiting function of the contralateral extremity
- •Medical or psychological condition that would preclude functional testing (ex. moderate or severe brain injury, stroke, heart disease)
- •Wounds to the calf that would prevent CDO fitting
- •Fractures secondary to neuropathy or severe osteopenia
- •Classification as non-ambulatory
- •Previous fractures near the tibial pilon on the involved limb
- •Surgery on involved limb anticipated in the next 6 months
- •Requirement of a knee stabilizing device (i.e. KAFO, KO…) to perform daily activities
- •Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
- •BMI greater than 40
- •Pregnancy- Per participant self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study.
- •HEALTHY ABLE-BODIED PARTICIPANTS:
- •Patient Inclusion Criteria
- •Between the ages of 18 and 65
- •Shoe size between women's 8 and 13.5 or men's 6.5 and 13
- •Healthy individuals without a current complaint of lower extremity pain, spine pain, or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months
- •Full active range of motion of the bilateral lower extremities and spine
- •Ability to hop without pain
- •Ability to perform a full squat without pain
- •Ability to read and write in English and provide written informed consent
- •Patient Exclusion Criteria
- •Diagnosed moderate or severe brain injury
- •Prior lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
- •Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
- •Visual or hearing impairment that would interfere with instructions given during testing
- •Require an assistive device
- •Wounds to the foot or calf that would prevent CDO use
- •BMI greater than 40
- •Pregnancy - Per participant self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study
研究组 & 干预措施
No Device
Participants will be evaluated without a CDO.
CDO-A
The first design variant will be designated CDO-A
干预措施: Custom Carbon Fiber Dynamic Orthosis (CDO) (Device)
CDO-B
The second design variant will be designated CDO-B
干预措施: Custom Carbon Fiber Dynamic Orthosis (CDO) (Device)
CDO-C
The third design variant will be designated CDO-C
干预措施: Custom Carbon Fiber Dynamic Orthosis (CDO) (Device)
结局指标
主要结局
Peak Plantar Force (Midfoot)
时间窗: Baseline
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (middle 30% of sensor) as participants walk without a CDO and with each CDO.
Peak Plantar Force (Forefoot)
时间窗: Baseline
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO.
Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC)
时间窗: Baseline
The participant will rank order their preference for their standard of care device (if applicable), No Device, CDO-A, CDO-B, CDO-C on a questionnaire.
Participant Device Preference (First Preferred Condition)
时间窗: Baseline
Participants were asked to rank order their preference for NoCDO, CDO-A, CDO-B, CDO-C on a questionnaire.
Joint Contact Stress Time Exposure (Model Estimated)
时间窗: Baseline
Joint contact stress time exposure (MPA-s/gait cycle) was estimated using a participant specific musculoskeletal model. Peak joint contact stress time exposure (MPA-s/gait cycle) acting on the tibia during the gait cycle were reported. Lower peak contact stress time exposure is considered a better outcome.
Peak Plantar Force (Total Foot)
时间窗: Baseline
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (100% of sensor) and normalized to participant body weight as they walk.
Peak Plantar Force (Hindfoot)
时间窗: Baseline
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (proximal 30% of sensor) as participants walk without a CDO and with each CDO.
Plantar Force Impulse (Total Foot)
时间窗: Baseline
Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (100% of sensor) will be calculated using the integral of the force over the stance phase and normalized to participant body weight as they walk.
Plantar Force Impulse (Hindfoot)
时间窗: Baseline
Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Plantar Force Impulse (Midfoot)
时间窗: Baseline
Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Plantar Force Impulse (Forefoot)
时间窗: Baseline
Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS)
时间窗: Baseline
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Lower values are better as they indicate less pain.
Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS)
时间窗: Baseline
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Lower values are better as they indicate less pain
Participant Device Preference (Second Preferred Condition)
时间窗: Baseline
Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).
Participant Device Preference (Third Preferred Condition)
时间窗: Baseline
Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).
Participant Device Preference (Fourth Preferred Condition)
时间窗: Baseline
Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).
次要结局
- Peak Soleus Muscle Force (Model Estimated)(Baseline)
- Peak Gastrocnemius Muscle Force (Model Estimated)(Baseline)
- Ankle Range of Motion(Baseline)
- Peak Ankle Moment(Baseline)
- Peak Ankle Power(Baseline)
- Four Square Step Test (4SST)(Baseline)
- Sit to Stand 5 Times (STS5)(Baseline)
- The Orthotics Prosthetics Users' Survey (OPUS)(Baseline)
- Modified Socket Comfort Score (Comfort)(Baseline)
- Modified Socket Comfort Score (Smoothness)(Baseline)
研究者
Jason Wilken
Director of Collaborative Research and Development, Associate Professor
University of Iowa