A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in Arc of Flexion and Extension
研究概览
简要总结
Primary Question: "When splinting is used to improve motion in post-traumatic stiff elbows, is there a significant difference in gains in motion achieved between static progressive or dynamic splint approaches?"
Secondary Question: "Is there a significant difference in patient compliance with static progressive versus dynamic splint use, and does this effect final ulnohumeral motion outcomes?"
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
- 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
- •All adult patients with post-traumatic elbow contractures in the Hand and Upper Extremity Service at Massachusetts General Hospital are eligible to for enrollment in this study regardless of sex, race or ethnicity.
排除标准
- •Only English speaking patients will be eligible for the study since questionnaires have not been validated in other languages.
- •Vulnerable populations will not be recruited.
研究组 & 干预措施
Dynamic Splint
干预措施: Dynamic Splint (Device)
Static-progressive splint
干预措施: Static-Progressive Splint (Device)
结局指标
主要结局
Change in Arc of Flexion and Extension
时间窗: baseline and 6 months
Active ulnohumeral motion will be measured using a hand-held goniometer by the co-investigator not involved in the care of the patient at enrollment and 6 months after enrollment.
次要结局
- Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire(12 months)
研究者
David C. Ring, MD
Director of Research, Hand Service
Massachusetts General Hospital