Gait Modification for Knee Osteoarthritis (SENSMOD)
2020年10月15日 更新者：Michael Hunt、University of British Columbia
Foot Progression Angle Modification: an Exploratory Six-week Intervention in People With Knee Osteoarthritis
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
3
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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British Columbia
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Vancouver、British Columbia、加拿大、V6T 1Z3
- Motion Analysis and Biofeedback Laboratory
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Specific Modification Target
A 15 degree relative increase to foot progression angle
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Participants will be instructed to increase their baseline foot progression angle by 15 degrees.
Visual feedback during practice will be delivered using a mirror and guideline (tape placed on mirror).
Verbal feedback will be incorporated to encourage participants to perform the modified foot progression angle as accurately as possible.
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实验性的：Self-directed Modification
A self-directed increase to foot progression angle that is "as much as is comfortable".
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Participants will be instructed to modify their foot progression angle as much as is comfortable.
A mirror will be used during practice for visual feedback, but no specific target or guide will be provided.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in baseline to week 7 foot rotation angle error during stance - in lab walking
大体时间：Baseline, Week 7
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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.
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Baseline, Week 7
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Weekly change in baseline foot rotation angle error during stance - at home walking and during practice sessions
大体时间：Baseline, Weeks 1, 2, 3, 4, 5, 6, 7
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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.
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Baseline, Weeks 1, 2, 3, 4, 5, 6, 7
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in baseline to week 7 knee joint moment impulse
大体时间：Baseline, Week 7
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Knee flexion and adduction moment impulses will be calculated.
Participants will walk on an instrumented walkway (2 force platforms) while 14 high speed cameras track the trajectories of markers placed on boney landmarks.
Moments will be calculated using an inverse dynamics approach.
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Baseline, Week 7
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Change in baseline to week 7 Knee Injury and Osteoarthritis Outcome Score (KOOS)
大体时间：Baseline, Week 7
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Validated questionnaire on symptoms and functional limitations related to knee osteoarthritis.
The score is expressed in percentage (0-100), with 0 representing extreme knee problems and 100 representing no knee problems.
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Baseline, Week 7
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Change in baseline to week 7 knee pain on a numerical rating scale
大体时间：Baseline, Week 7
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Knee pain rated on a 0 to 10 scale.
0 = "no pain at all" and 10 = "worst pain imaginable".
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Baseline, Week 7
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Change in week 1 to week 7 difficulty performing the modification on a numerical rating scale
大体时间：Week 1, 7
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Difficulty will be rated on a 0 to 10 scale.
0 = "no difficulty at all" and 10 = "most difficulty imaginable".
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Week 1, 7
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Michael Hunt, PT, PhD、University of British Columbia
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年2月20日
初级完成 (实际的)
2020年3月12日
研究完成 (实际的)
2020年3月12日
研究注册日期
首次提交
2020年2月3日
首先提交符合 QC 标准的
2020年3月25日
首次发布 (实际的)
2020年3月27日
研究记录更新
最后更新发布 (实际的)
2020年10月19日
上次提交的符合 QC 标准的更新
2020年10月15日
最后验证
2020年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.