Iterative Design of Custom Dynamic Orthoses and Comprehensive Design of Musculoskeletal Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Joint Contact Stress-Time Exposure
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. It is expected that carbon fiber braces can be designed to reduce forces in the ankle. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.
详细描述
The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.
Healthy adult participants will complete testing using three generic sized carbon fiber custom dynamic orthoses (CDOs) and with no CDO. 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.
The information obtained from this study will help refine the musculoskeletal model data input methods to be used in future studies. The knowledge that will be gained from this investigation has the potential to substantially improve the long-term efficacy and efficiency of the musculoskeletal model and help improve ankle foot orthosis
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 and 50
- •Shoe size between women's 8 and 13.5 or men's 6.5 and 12
- •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
排除标准
- •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 35
- •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
NoCDO, CDOA, CDOB, CDOC
Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC.
干预措施: Carbon Fiber Custom Dynamic Orthosis (CDO) (Device)
NoCDO, CDOA, CDOC, CDOB
Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB.
干预措施: Carbon Fiber Custom Dynamic Orthosis (CDO) (Device)
NoCDO, CDOB, CDOA, CDOC
Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC.
干预措施: Carbon Fiber Custom Dynamic Orthosis (CDO) (Device)
NoCDO, CDOB, CDOC, CDOA
Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA.
干预措施: Carbon Fiber Custom Dynamic Orthosis (CDO) (Device)
NoCDO, CDOC, CDOA, CDOB
Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB.
干预措施: Carbon Fiber Custom Dynamic Orthosis (CDO) (Device)
NoCDO, CDOC, CDOB, CDOA
Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA.
干预措施: Carbon Fiber Custom Dynamic Orthosis (CDO) (Device)
结局指标
主要结局
Joint Contact Stress-Time Exposure
时间窗: Baseline
Joint contact stress-time exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model. The model included surface geometry of each participants tibia and talus. Contact stress -time exposure, measured in MPa-s, was calculated at 13 points across the gait cycle. Higher values indicate greater contact stress-time exposure.
次要结局
- Peak Ankle Moment(Baseline)
- Plantar Force (Hindfoot)(Baseline)
- Ankle Range of Motion(Baseline)
- Plantar Force (Total Foot)(Baseline)
- Modified Socket Comfort Score (Smoothness)(Baseline)
- Peak Ankle Power(Baseline)
- Plantar Force (Forefoot)(Baseline)
- Plantar Force (Midfoot)(Baseline)
- Soleus Muscle Force (N)(Baseline)
- Gastrocnemius Muscle Force (N)(Baseline)
- Four Square Step Test (4SST)(Baseline)
- Numerical Pain Rating Scale(Baseline)
- Sit to Stand 5 Times (STS5)(Baseline)
- The Orthotics Prosthetics Users' Survey (OPUS)(Baseline)
- Modified Socket Comfort Score (Comfort)(Baseline)
研究者
Jason Wilken
Associate Professor
University of Iowa