Foot Progression Angle Modification: an Exploratory Six-week Intervention in People With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in baseline to week 7 foot rotation angle error during stance - in lab walking
研究概览
简要总结
This randomized clinical trial will compare the changes in performance, biomechanical and clinical outcomes before and after a six-week gait modification intervention. Participants with knee osteoarthritis will attend in-lab assessments and practice, while also performing daily, at-home walking tracked using a custom sensorized shoe.
详细描述
Greater toe-in or toe-out angles during walking are potential biomechanical management strategies for medial compartment knee osteoarthritis (OA). Multi-week clinical trials demonstrate the biomechanical efficacy and potential clinical efficacy. However, walking biomechanics have only been assessed within laboratory environments and performance of the modifications during daily at-home walking is currently unknown. Furthermore, the modifications have largely been instructed using a specific target, requiring motor learning. No study has examined whether a self-directed strategy is feasible and will produce significant improvements in biomechanical and clinical outcomes. Moreover, objective real-world performance of these modifications is unknown and may explain the previous inconsistent clinical results. This study will address these gaps. The investigators hypothesize that real-world performance of the modifications will improve over the intervention and that both groups will exhibit improvements in biomechanical and clinical outcomes at follow up.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 50 years of age or greater
- •Exhibit signs of tibiofemoral OA (a score of ≥ 2 on the Kellgren and Lawrence (KL) grading scale) predominantly in the medial compartment,
- •Self-reported knee pain ≥ 3 / 10 on a numerical rating scale of pain (NRS; 0 = "no pain" and 10 = "worst pain imaginable") during most days of the previous month
- •Are comfortable walking intermittently for 30 minutes
- •Fit into the available sizes of sensorized shoes (sizes spanning US women's 5 to men's 13)
- •Exhibit at least a 5% reduction in knee adduction moment impulse for 10 degrees of change to foot rotation measured during a screening appointment.
排除标准
- •Any knee surgery or intraarticular injections within the past 6 months
- •A history of joint replacement surgery or high tibial osteotomy
- •Current or recent (within 6 weeks) corticosteroid injections
- •Use of a gait aid
- •Currently on a wait list for joint replacement surgery or high tibial osteotomy
- •Any inflammatory arthritic condition
- •Any other conditions that may affect normal gait or participation in an aerobic exercise program
- •Cannot attend all required appointments.
结局指标
主要结局
Change in baseline to week 7 foot rotation angle error during stance - in lab walking
时间窗: Baseline, Week 7
Foot rotation is the specific walking parameter that will be modified during the intervention. It is defined as the angle between the long axis of the foot (heel to toe) and the walking direction. Foot rotation will be measured via standard marker-based motion capture and sensor-based motion capture during baseline, follow up, and each practice session.
Weekly change in baseline foot rotation angle error during stance - at home walking and during practice sessions
时间窗: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7
Foot rotation is the specific walking parameter that will be modified during the intervention. It is defined as the angle between the long axis of the foot and the walking direction. Foot rotation will be measured via sensor-based motion capture over each week of the intervention. Median and inter-quartile ranges will be taken as the primary summary statistic.
次要结局
- Change in baseline to week 7 Knee Injury and Osteoarthritis Outcome Score (KOOS)(Baseline, Week 7)
- Change in baseline to week 7 knee pain on a numerical rating scale(Baseline, Week 7)
- Change in baseline to week 7 knee joint moment impulse(Baseline, Week 7)
- Change in week 1 to week 7 difficulty performing the modification on a numerical rating scale(Week 1, 7)
研究者
Michael Hunt
Associate Professor
University of British Columbia