Protocol for the Clinical Validation of a Valgus Knee Brace for Gonarthrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Ease of Use Measurement Scale
研究概览
简要总结
A study about the effects of different fastening systems for knee braces on comfort, ease of installation and treatment efficacy both physical and psychological. Two different systems will be tested, velcro straps and a cable-fastening system.
详细描述
There are 2 main types of knee braces for gonarthrosis: soft knee braces and rigid knee braces. Soft knee braces use malleable materials such as cloth or rubber to apply forces on the leg whereas rigid braces use plastic or metal shells. Three main types of fastening systems are used on these types of orthoses: velcro systems, hybrid systems and cable fastening systems. Therefore, different configurations exist to reduce biomechanical deficits caused by the pathology.
Each fastening system has its advantages and disadvantages. Velcro straps are fast and intuitive to use, altough multiple difficulties are mentionned: adjusment, cleaning, the number of straps needed to maintain the knee brace in position as well as the noise while detaching the straps. Hybrid systems regularly use velcro straps to which are added quick-release fasteners to simplify the installation and uninstallation process. Cable fastening systems also use quick-release fasteners. The adjusment process is simple and precise with minimal noise with these systems.
Comfort, efficacy and ease of use are essential qualities of a knee brace. Confort is primordial as it is directly linked to treatment adherence by the patients. Efficacy of a knee brace treatment may be measured by symptom or medication use evolution but also with daily practice of problematic movement by the patient. Ease of use must be optimized as it presents an opportunity to increase treatment adherence. The goal of the fastening system developped in partnership with Laboratoires Victhom is to increase ease of use of the knee brace while maintaining comfort and treatment efficacy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has worn an ODRA knee brace multiple hours a day during the last 6 months
排除标准
- •Wounds on the lower body
研究组 & 干预措施
Adjustement period(velcro)first, then Cable fastening system then Velcro Straps
A new knee brace is worn for a 14 days adjustement period with velcro straps. Then the brace is worn with a cable fastening system for a first 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps. The second 14 days intervention period is done with velcro straps keeping the brace in position.
干预措施: Cable fastening system and 3d printed straps(14 days) (Device)
Adjustement period(velcro)first, then Cable fastening system then Velcro Straps
A new knee brace is worn for a 14 days adjustement period with velcro straps. Then the brace is worn with a cable fastening system for a first 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps. The second 14 days intervention period is done with velcro straps keeping the brace in position.
干预措施: Velcro straps system(14 days) (Device)
Adjustement period(velcro)first, then Cable fastening system then Velcro Straps
A new knee brace is worn for a 14 days adjustement period with velcro straps. Then the brace is worn with a cable fastening system for a first 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps. The second 14 days intervention period is done with velcro straps keeping the brace in position.
干预措施: Adjustment period(Velcro-14 days) (Device)
Adjustement period(velcro)first, then Velcro Straps then Cable fastening system
A new knee brace is worn for a 14 days adjustement period with velcro straps. The first 14 days intervention period is done with velcro straps keeping the brace in position. Then the brace is worn with a cable fastening system for a second 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps.
干预措施: Cable fastening system and 3d printed straps(14 days) (Device)
Adjustement period(velcro)first, then Velcro Straps then Cable fastening system
A new knee brace is worn for a 14 days adjustement period with velcro straps. The first 14 days intervention period is done with velcro straps keeping the brace in position. Then the brace is worn with a cable fastening system for a second 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps.
干预措施: Velcro straps system(14 days) (Device)
Adjustement period(velcro)first, then Velcro Straps then Cable fastening system
A new knee brace is worn for a 14 days adjustement period with velcro straps. The first 14 days intervention period is done with velcro straps keeping the brace in position. Then the brace is worn with a cable fastening system for a second 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps.
干预措施: Adjustment period(Velcro-14 days) (Device)
结局指标
主要结局
Ease of Use Measurement Scale
时间窗: Directly after the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use)
Comfort Measurement Scale
时间窗: Directly after the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
The scale was developped for this study. The mesure is an average of 2 items with 5 point scale rating system(1 lowest comfort; 5 highest comfort). Total score is adjusted to 0 (lowest comfort) to 100 (highest comfort).
Psychological Symptoms
时间窗: Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm
Psychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Minimum=0; (No symptoms); Maximum=100(Worst Symptoms);
Physical Symptoms
时间窗: Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm
Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms);
Ease of Use Measurement Scale
时间窗: Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use)
Comfort Measurement Scale
时间窗: Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
The scale was developped for this study. The mesure is an average of 2 items with 5 point scale rating system(1 lowest comfort; 5 highest comfort). Total score is adjusted to 0 (lowest comfort) to 100 (highest comfort).
Physical Symptoms
时间窗: Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period.
Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms);
Psychological Symptoms
时间窗: Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period.
Psychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Minimum=0; (No symptoms); Maximum=100(Worst Symptoms);
次要结局
未报告次要终点