Effectiveness of a Walking Intervention on Impact Loading and Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
This study investigates the feasibility of a gait-retraining program for older adults with knee osteoarthritis. The study will enroll 40 participants, with 20 receiving a gait retraining intervention and 20 receiving a graded walking program without gait retraining.
详细描述
Knee osteoarthritis (OA) is a chronic condition affecting ~12% of older adults in the United States and is a leading cause of disability. Knee pain is a common clinical manifestation that leads individuals with OA to seek medical care. Current rehabilitation approaches (e.g., bracing, taping, foot orthoses, strengthening, etc.) aim to reduce knee joint loading, a well-accepted risk factor for knee OA and pain, but are not always effective. Altering gait mechanics to reduce knee loading has also been suggested. Gait retraining studies for individuals with knee OA have focused on increasing trunk lean and toe out angle to reduce the knee adduction moment (a surrogate measure of joint loading). However, these strategies create an abnormal gait pattern and may not be the best long-term solutions due to the potential injury to other joints which may limit their overall effectiveness and applicability to clinical practice. Impact loading, another mechanical factor related to knee OA, has been reduced using gait retraining strategies in runners with knee pain. It is unknown if gait retraining strategies to decrease impact loading can reduce symptoms of knee OA. Thus, the purpose of this study is to determine the feasibility of a gait retraining program focusing on decreasing impact loading in individuals with knee OA.
At baseline, following 8 intervention sessions, and at 1-month follow-up, participants will complete questionnaires, undergo three-dimensional gait analysis, and assessment of pressure pain threshold.
Note: For participants enrolled during COVID-19 outbreak, only questionnaires will be collected at follow-up assessments.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a clinical definition of knee OA using NICE guidelines:
- •Walking related joint pain in the last week that averages ≥ 4 on 11-point numeric rating scale, where 0 = no pain and 10 = worst pain possible
- •History of knee pain for at least 3 months
- •Morning stiffness in the morning lasting less than 30 minutes
排除标准
- •Walk with an assistive device
- •Current use of oral opiates or centrally acting pain medications
- •History of lower extremity surgery
- •Underwent an intra-articular knee joint injection in the past 3 months
- •Suffer from inflammatory arthritis or other conditions that affect lower extremity functions
- •Currently receiving treatment for their knee and unwilling to stop this treatment for the duration of the study
- •Currently pregnant
- •Skin allergies to adhesives
研究组 & 干预措施
Progressive walking program with gait retraining
Participant will receive 8 gait-retraining intervention sessions.
干预措施: Progressive Walking with Gait Retraining (Behavioral)
Progressive walking program
Participant receives 8 sessions of a graded walking program.
干预措施: Progressive Walking Program (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: through study completion, an average of 2 years
# of participants screened per month
Enrollment rate
时间窗: through study completion, an average of 2 years
# of participants enrolled per month
Retention
时间窗: through study completion, an average of 2 years
% participants that complete all study visits
次要结局
- Withdrawals/Terminated(through study completion, an average of 2 years)
- Adverse events (AE)/Unanticipated problems (UP)(through study completion, an average of 2 years)
- Vertical average loading rate(Change from baseline to conclusion of intervention, an average of 1-month)
- Vertical instantaneous loading rate(Change from baseline to conclusion of intervention, an average of 1-month)
- Knee Pain with Activities(Change from baseline to conclusion of intervention, an average of 1-month)
- Knee Pain Severity(Change from baseline to conclusion of intervention, an average of 1-month)
- Pressure pain threshold(Change from baseline to conclusion of intervention, an average of 1-month)