Personalized Gait Training with Feedback to Reduce Knee Pain from Osteoarthritis

带反馈的个性化步态训练可减少骨关节炎引起的膝盖疼痛

• 批准号: 9333110
• 负责人: Gary Beaupre
• 金额: --
• 依托单位: VETERANS ADMIN PALO ALTO HEALTH CARE SYS
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-10-01 至 2020-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9333110
• 关键词: Accelerometer; Address; Adult; Age; American; Anti-Inflammatory Agents; Anti-inflammatory; Arthritis; Canes; Cartilage; Cartilage Matrix; Clinical; Clinical assessments; Communities; Control Groups; Degenerative polyarthritis; Devices; Disease Progression; Educational Intervention; Feedback; Foundations; Gait; Health; Individual; Intervention; Joints; Knee; Knee Osteoarthritis; Knee joint; Lateral; Lead; Leg; MRI Scans; Magnetic Resonance Imaging; Measures; Medial; Modality; Modification; Monitor; Multi-Institutional Clinical Trial; Operative Surgical Procedures; Orthopedics; Pain; Pamphlets; Participant; Patient Recruitments; Patients; Pattern; Pharmaceutical Preparations; Phase; Phonation; Pilot Projects; Placebo Effect; Protocols documentation; Questionnaires; Randomized Controlled Trials; Reaction; Recreation; Regimen; Reporting; Research; Research Personnel; Rotation; Self-Direction; Shoes; Signal Transduction; Telephone; Testing; Thinness; Time; Toes; Training; Veterans; Visual Analogue Pain Scale; Walking; Weight-Bearing state; Western Ontario and McMaster Universities Arthritis Index; articular cartilage; base; clinically relevant; cost; demographics; experience; foot; gait rehabilitation; gait retraining; kinematics; knee pain; knee replacement arthroplasty; novel; orthotics; personalized approach; personalized intervention; programs; sensory feedback; skeletal tissue; social; social stigma; soft tissue; treadmill; vibration; walking program

This study is a randomized controlled trial to investigate a novel treatment for patients with painful knee osteoarthritis. The study will recruit patients who have osteoarthritis isolated to the medial compartment of the knee. Half of the patients will participate in a gait retraining program to alter their foot placement during walking; the other half will be assigned to a self-directed walking group. Gait retraining will be subject-specific and will depend on a key feature of each subject's baseline gait, namely which peak (early or late) in the bi-modal knee adduction moment (KAM) profile is larger. The retraining will involve changing the foot progression angle, which is the angle the foot makes relative to the forward direction. The intervention will involve either increasing internal foot rotation (toe-in) or increasing external foot rotation (toe-out). Previously, toe-in has been shown to reduce only the first peak, whereas toe-out has been shown to reduce only the second peak. Because of the personalized intervention, we expect all retrained subjects will be able to reduce the (larger) peak KAM and to reduce knee pain. Based on previous studies, we expect that approximately 80% of subjects in the gait retraining group will need to increase toe-in, and 20% of subjects will need to increase toe-out. Gait retraining will be done using a vibration feedback device taped to the lower leg as each subject walks on a treadmill. Body segment kinematics will be captured and ground reaction forces will be measured. During each step, subjects will receive vibration feedback informing them how they should change their foot progression angle during the next step. Real-time feedback facilitates training since an individual knows immediately whether their foot placement was correct or not, and they are informed via the feedback signal whether or not to change their foot angle during the next step. The gait retraining consists of once a week sessions for six weeks. The training uses a fading feedback approach, where the percentage of each weekly session during which feedback is used is decreased from week to week until no feedback is used by the last training session. At that point the new gait pattern is internalized and that new pattern then represents the new “natural” gait pattern for each individual. Throughout the six-week training period subjects will be encouraged to practice their new gait for at least ten minutes per day. After the six-week training, subjects will continue to use their new gait. Subjects will undergo gait lab checks at weeks 21, 31 and 41 and monitoring of foot progression angle under free-living conditions using “smart” shoes during weeks 8, 31 and 52 to assess retention, with refresher training if necessary. Their last assessment will be at 52 weeks. Participants in the control group will receive an educational pamphlet developed by the Arthritis Foundation that describes the benefits of regular walking for those with arthritis. A self-directed walking program has be shown to provide pain relief for those with knee osteoarthritis, although we expect the patients who undergo gait retraining will have an additional benefit from a reduction in excessive forces on the medial compartment of the knee, thereby slowing disease progression. All subjects will receive a monthly phone call to encourage maintaining a regular walking regimen for 52 weeks. The gait retraining group also will be reminded to focus on practicing their new gait pattern. For both groups, walking activity will be monitored for one week using an accelerometer- based pedometer during weeks 7, 31 and 52. All subjects will receive a Magnetic Resonance Imaging scan and weight-bearing knee radiographs at weeks 0 and 52 to assess knee cartilage composition and organization, and joint space, respectively. All participants will also complete clinical knee score questionnaires and visual analog pain scales at weeks 0, 7, 11, 31 and 52.

本研究是一项随机对照试验，旨在研究一种治疗疼痛患者的新疗法 膝骨关节炎。该研究将招募患有内侧孤立性骨关节炎的患者 膝盖的隔间。一半的患者将参加步态再训练计划以改变他们的行为 步行时脚的位置；另一半将被分配到一个自我指导的步行小组。步态 再训练将针对具体科目，并取决于每个科目基线步态的关键特征， 即双峰膝关节内收力矩 (KAM) 轮廓中的哪个峰值（早期或晚期）较大。这 再训练将涉及改变脚的前进角度，即脚相对的角度 向前进的方向。干预措施包括增加足部内部旋转（脚趾向内）或 增加足部外旋（脚趾外翻）。此前，前束已被证明只能减少第一个 峰值，而脚趾外翻已被证明只能减少第二个峰值。因为个性化 干预后，我们预计所有接受过再培训的受试者都能够降低（较大的）KAM 峰值并 减少膝盖疼痛。根据之前的研究，我们预计大约 80% 的受试者 步态再训练组需要增加前束，20%的受试者需要增加前束。 步态再训练将通过在每次训练时贴在小腿上的振动反馈装置来完成。 对象在跑步机上行走。将捕获身体部分的运动学和地面反作用力 将被测量。在每个步骤中，受试者都会收到振动反馈，告知他们如何 他们应该在下一步中改变脚部前进角度。实时反馈有利于 训练，因为个人立即知道他们的脚的位置是否正确，并且 他们通过反馈信号得知是否在下一次改变脚部角度 步。步态再训练包括每周一次、为期六周的训练。训练中使用了衰落 反馈方法，其中使用反馈的每周会议的百分比为 每周减少，直到最后一次训练课程没有使用反馈。那时 新的步态模式被内化，并且新的模式代表新的“自然”步态模式 对于每个人来说。在整个六周的培训期间，将鼓励受试者进行练习 他们每天至少坚持十分钟的新步态。经过六周的培训后，受试者将继续 使用他们的新步态。受试者将在第 21、31 和 41 周接受步态实验室检查并监测 第 8、31 和 52 周期间使用“智能”鞋自由生活条件下的足部进展角度 评估保留率，必要时进行复习培训。他们的最后一次评估将在 52 周时进行。 对照组的参与者将收到关节炎协会开发的教育小册子 基金会描述了定期步行对关节炎患者的好处。一个自导自演的 步行计划已被证明可以缓解膝骨关节炎患者的疼痛，尽管我们 预计接受步态再训练的患者将从减少步态中获得额外的好处 膝关节内侧间室受力过大，从而减缓疾病进展。 所有受试者每月都会接到电话，以鼓励保持规律的步行习惯 52 周。步态再训练小组也会被提醒集中精力练习新步态 图案。对于两组，步行活动将使用加速度计进行为期一周的监测 - 在第 7、31 和 52 周期间使用基于计步器的计步器。所有受试者都将接受磁共振成像 第 0 周和第 52 周时进行扫描和负重膝关节 X 光片，以评估膝关节软骨成分 分别是组织和联合空间。所有参与者还将完成临床膝盖评分 第 0、7、11、31 和 52 周时进行问卷调查和视觉模拟疼痛量表。