Comparative Effect of Commercially Available Custom Dynamic Orthoses (CDOs)
概览
- 阶段
- 不适用
- 干预措施
- Reaktiv AFO
- 疾病 / 适应症
- Foot Injuries and Disorders
- 发起方
- Jason Wilken
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- Center of Pressure Velocity Magnitude
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
The proposed effort is designed to support evidence-based practice and optimal care by evaluating how the form, fit and function of two commercially available carbon fiber custom fit braces (Orthoses) influences outcomes following extremity injury. Early data suggests that custom fit carbon fiber braces can significantly improve function following severe lower leg injuries. The proposed study will provide evidence that can be used by clinicians to guide their practice, including care for service members, veterans and civilians who have experienced a high-energy traumatic injury to their lower leg.
详细描述
In this research study, adult participants who have sustained a below-the-knee traumatic injury greater than two years ago and are still experiencing deficits including weakness and/or immobility will be assigned to one of two brace sequences (AB or BA). Participants will be randomized to a particular sequence, with an equal chance of getting either order. Participants will be evaluated under 4 conditions: no device, standard of care, and 2 carbon fiber custom dynamic orthoses (CDO), the Reaktiv device from FabTech Systems and the PhatBrace by Bio-Mechanical Composites Inc. Participants will be tested with no device and standard of care at baseline, after 3 months of accommodation to the Reaktiv, and 3 months of accommodation to the PhatBrace. A series of study measures will be performed. The physical performance measures will incorporate tests of agility, balance, speed and lower limb power. Questionnaires will be used to evaluate participant's perceived comfort and smoothness, pain, preference, and semi-structured interviews will be used to fully capture the perspective of the participant. A motion capture system will be used to evaluate walking mechanics, allowing comparisons between conditions. Lower limb forces and body motion will be assessed using computerized motion capture and force plates in the floor, as individuals walk over-ground. Small reflective markers placed on the participant's skin and force measuring plates in the floor will be used. The investigators will also complete mechanical testing of the devices and collect demographic and descriptive data.
研究者
Jason Wilken
Principal Investigator
University of Iowa
入排标准
入选标准
- •Ages: 18-65
- •Sustained a function limiting, below the knee, traumatic lower leg injury that occurred greater than two years ago
- •Weakness of ankle plantarflexors (\<4/5 on MMT), limited pain free ankle motion (DF\<10deg or PF\<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (\>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion or candidate for ankle or hindfoot fusion, AND/OR a candidate for amputation secondary to ankle/foot impairment
- •Ability to walk 50 feet without using a cane or crutch
- •Ability to walk at a slow to moderate pace
- •Able to read and write in English and provide written informed consent
排除标准
- •Pain \> 8/10 while walking
- •Ankle weakness as a result of spinal cord injury or central nervous system pathology
- •Require a knee stabilizing device (i.e. Knee-Ankle Foot Orthosis or Knee Orthosis) to perform daily activities
- •Surgery on study limb anticipated in the next 6 months
- •Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)
- •Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
- •BMI greater than 45
- •Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
- •Pregnancy- Per participant self-report. Due 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
AB
Participants in this arm will receive the Reaktiv AFO made by FabTech Systems LLC first, then the PhatBrace AFO by Bio-Mechanical Composites Inc. second.
干预措施: Reaktiv AFO
AB
Participants in this arm will receive the Reaktiv AFO made by FabTech Systems LLC first, then the PhatBrace AFO by Bio-Mechanical Composites Inc. second.
干预措施: PhatBrace AFO
BA
Participants in this arm will receive the PhatBrace AFO by Bio-Mechanical Composites Inc. first, then the Reaktiv AFO made by FabTech Systems LLC second.
干预措施: Reaktiv AFO
BA
Participants in this arm will receive the PhatBrace AFO by Bio-Mechanical Composites Inc. first, then the Reaktiv AFO made by FabTech Systems LLC second.
干预措施: PhatBrace AFO
结局指标
主要结局
Center of Pressure Velocity Magnitude
时间窗: 3 months
Magnitude of peak center of pressure velocity (m/s) during gait.
Satisfaction With Device (OPUS - CSD)
时间窗: 3 months
Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Higher scores indicate a better outcome.
PROMIS Patient Reported Outcomes for Physical Function
时间窗: 3 months
The Patient Reported Outcome Information System (PROMIS) physical function Computer Adaptive Test (CAT) is a computerized assessment measuring physical function. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.
PROMIS Patient Reported Outcomes for Pain Interference
时间窗: 3 months
The Patient Reported Outcome Information System (PROMIS) pain interference Computer Adaptive Test (CAT) is a computerized assessment measuring pain interference. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.
Activities-Specific Balance Confidence (ABC)
时间窗: 3 months
The Activities-Specific Balance Confidence (ABC) scale provides a standardized evaluation of balance confidence across a range of common daily tasks. Higher scores indicate more confidence, with 0 = no confidence and 100 = full confidence.
Modified Socket Comfort Score (Comfort)
时间窗: 3 months
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Modified Socket Comfort Score (Comfort and Smoothness)
时间窗: 3 months
Smoothness scores range from 0 = least smooth to 10 = most smooth.
Numerical Pain Rating Scale
时间窗: 3 months
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Participant Device Preference
时间窗: After 3 months of accomodation with the final device (Crossover study)
The participant will rank order their preference for the Reaktiv and Phatbrace on a questionnaire.
Four-square Step Test (4SST- Timed)
时间窗: 3 months
The 4SST is a standardized timed test of balance and agility. Measured in seconds with lower scores indicating better balance and agility.
Self-selected Walking Velocity (SSWV - Timed)
时间窗: 3 months
SSWV will be assessed using the timed 10 meter walk test. Measured in seconds.
10 Meter Shuttle Run (10M Shuttle - Timed)
时间窗: 3 months
The 10 meter shuttle run is a well-established timed measure of speed. Measured in seconds.
Ankle Joint Power
时间窗: 3 months
Peak ankle joint moment (W/kg) during gait.
Center of Pressure Velocity Timing
时间窗: 3 months
Timing of peak center of pressure velocity (percent stance) during gait.
次要结局
- PROMIS Patient Reported Outcomes for Satisfaction With Participation in Social Activities(3 months)
- Paffenbarger Physical Activity Questionnaire(Baseline)
- Ankle Joint Moment(3 months)