Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Thuasne
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Knee Adduction Moment
研究概览
简要总结
Osteoarthritis is a chronic disease affecting millions of people worldwide, and knee is the second most affected site. Knee osteoarthritis is characterized by knee pain, loss of motion, disability, and muscle weakness, all factors contributing to gait alterations, and impacting greatly the patients quality of life. In the absence of curative treatment, pharmacological and non-pharmacological symptomatic treatments are prescribed to maintain this QoL, and therefore delay surgery to more appropriate window of opportunity later in life.
The aim of the study was to investigate the acute effects of three braces, using different unloading strategies, on gait kinematic and kinetic parameters, as well as pain in patients with medial knee ostoeoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unilateral medial KOA classified II or III on the Kellgren-Lawrence scale
- •varus misalignment with a joint space of at least two finger breadths
- •pain level equal or higher than 30 mm on a 100 mm visual analog scale
- •informed written consent
排除标准
- •limited ability to walk
- •normoaxial knee alignment
- •intra-articular injection of a local treatment including corticosteroids in the 3 months or hyaluronic acid in the 6 months preceding its inclusion or analgesic or NSAID treatment with a wash-out period equal to 5 half-lives of the drug concerned
- •undergoing physiotherapy
- •cognitive disorders or behavioral disorders (opposition, agitation, dementia)
- •arteriopathy of the lower limbs
- •skin disorders contraindicating the wearing of rigid orthotics
- •severe varicosity preventing the regular wearing of unloading brace
研究组 & 干预措施
Rebel Reliever
Rebel Reliever (RR) (Thuasne, Levallois Perret, France) with bilateral rigid frames and two hinges. The valgus correction was set by adjusting the medial and lateral frame lengths to a difference of two or three points as dictated by the participant's feeling and comfort. Six straps maintained the brace in place
干预措施: Rebel Reliever (RR) (Device)
Action Reliever
Action Reliever (AR) (Thuasne, Levallois Perret, France) made mainly from textile. Upper and lower straps were adjusted to the participant's feeling and comfort.
干预措施: Action Reliever (Device)
Unloader One
Unloader One (UO) (Össur, Reykjavik, Iceland), with unilateral frame and one hinge. Upper and lower straps were adjusted to the setting recommended by the fitting instructions and confirmed by the participant's sensation.
干预措施: Unloading brace (Device)
No orthosis
Control condition without brace
结局指标
主要结局
Knee Adduction Moment
时间窗: Day : 1
Main parameter determined from the force platforms: - Position of the center of gravity By coupling the techniques of kinematic measurement and ground reaction force, we obtain the Moment of Adduction (or KAM) when walking
次要结局
- Step length(Day: 1)
- Impact and propulsive reaction force of the ground(Day: 1)
- Satisfaction related to the device(Day: 1)
- Perceived pain(Day: 1)
- Adduction/abduction angles(Day: 1)
- Walking speed(Day: 1)