Effects of Toe-out Gait Modification on Clinical and Biomechanical Measures in People With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Change From Baseline to Week 17 and From Baseline to Week 21 in Pain as Measured by Numerical Rating Scale
研究概览
简要总结
Knee osteoarthritis (OA) is a costly health condition affecting more than 10% of Canadian adults. Excessive and unbalanced loads passing through the knee joint have been implicated in the progression of OA. Typical conservative treatment of OA has focused on increasing daily activity, without consideration for the underlying joint loading. This study aims to compare a 4-month walking program that aims to increase the angle of the foot (toe-out angle) during walking - a measure shown to reduce joint loading and OA disease progression - while increasing walking time/distance, with a standard walking program that aims to increase walking time/distance. It is predicted that the walking program focusing on increasing toe-out will provide greater reductions in self-reported knee pain and a greater reduction in unfavorable knee joint loading.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 50 years and older
- •radiographically confirmed medial compartment tibia-femoral knee osteoarthritis
- •available for weekly training sessions in the Vancouver British Columbia Canada region
- •able to safely perform treadmill walking under therapist supervision
排除标准
- •articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial
- •inflammatory arthritic condition
- •history of knee replacement or arthroscopic knee surgery
- •recent use of corticosteroids (oral or via injection)
- •inability to ambulate without a gait aid
- •non-English speaking
- •planning to commence a new treatment approach within the next 4 months
研究组 & 干预措施
Gait Modification Group
Participants will complete 4 months of a home-based progressive walking program with toe-out gait modification aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with a study therapist and will be instructed to perform a toe-out gait, with the aid of a mirror during walking. Focus will also be on increasing the time and distance of walking. These goals will be emphasized for the home-based portion of the intervention as well.
干预措施: Progressive walking program with toe-out gait modification (Other)
Walking Only Group
Participants will complete 4 months of a home-based progressive walking program aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with the study therapist with focus on increasing the time and distance of walking. This goal will be emphasized for the home-based portion of the intervention as well.
干预措施: Progressive walking program (Other)
结局指标
主要结局
Change From Baseline to Week 17 and From Baseline to Week 21 in Pain as Measured by Numerical Rating Scale
时间窗: Weeks 0, 17, 21
Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = maximum pain). Higher scores mean a worse outcome. Change was calculated as the value at 17 weeks and at 21 weeks minus the value at baseline.
Change From Baseline to Week 17 and From Baseline to Week 21 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale.
时间窗: Weeks 0, 17, 21
Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. Minimum value of the WOMAC pain subscale is 0 and maximum value is 20. Higher scores mean a worse outcome.
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: First Peak Knee Adduction Moment
时间窗: Weeks 0, 17, 21
Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Second Peak Knee Adduction Moment
时间窗: Weeks 0, 17, 21
Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Adduction Moment Impulse
时间窗: Weeks 0, 17, 21
Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.
Change From Baseline to Week 17 and From Baseline to Week 21 in Foot Progression Angle (FPA)
时间窗: Weeks 0, 17, 21
FPA indicates orientation of the foot with respect to the forward progression of the body. Positive values correspond to a toe-in orientation, whereas negative values correspond to a toe-out orientation. Therefore, a positive change value indicates more toe-in versus a negative change value indicates more toe-out.
次要结局
- Change From Baseline to Week 17 and From Baseline to Week 21 in Self-reported Physical Function as Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale.(Weeks 0, 17, 21)
- Change From Baseline to Week 17 and From Baseline to Week 21 in Objective Physical Function as Measured by Timed Stair Climb.(Weeks 0, 17, 21)
- Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Flexion Moment(Weeks 0, 17, 21)
研究者
Michael Hunt
Associate Professor
University of British Columbia