NCT00717691已完成不适用
Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Active Range of Motion of Hallux (great toe) Extension
研究概览
简要总结
The purpose of this study is to regain range of motion of the great toe with dynamic splinting which will help reduce great toe's pain and swelling.
详细描述
Determine the efficacy of dynamic splinting in treating patients with hallux limitus, in a randomized, controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reduced flexibility in AROM of extension in the great toe
- •Pain that is worsened by walking and/or squatting
- •Impaired gait pattern
排除标准
- •Metatarsal stress fracture
- •Interdigital neuroma
- •Sesamoid pathology
- •Metatarsalgia
研究组 & 干预措施
1
Experimental
Immediate fitting with dynamic splinting following diagnosis of hallux limitus.
干预措施: Metatarsophalangeal Extension Dynasplint System (Device)
1
Experimental
Immediate fitting with dynamic splinting following diagnosis of hallux limitus.
干预措施: Standard of Care (Other)
2
No Intervention
Control arm; patients only treated with standard of care following diagnosis of hallux limitus.
干预措施: Standard of Care (Other)
结局指标
主要结局
Change in Active Range of Motion of Hallux (great toe) Extension
时间窗: Two Months
次要结局
- Change in passive Range of Motion, Extension(same)
研究者
研究点 (2)
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