Pilot Study on The Effectiveness of Relative Motion Orthosis in Finger Motion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in QuickDASH (Disability of the Arm, Shoulder, and Hand) score
研究概览
简要总结
The purpose of this feasibility pilot study is to determine the effectiveness of Relative Motion Orthosis (RMO) in regaining finger range of motion compared to standard care in patients diagnosed with Proximal Interphalangeal (PIP) stiffness with an extension lag secondary to finger injury. Participants will be enrolled and randomized into groups receiving either standard conservative interventions or standard interventions in addition to the RMO. The primary endpoint is to evaluate the efficacy of relative motion orthosis in PIP ROM using clinical scoring and physical exam findings.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 18-80
- •Any gender
- •Any Proximal Interphalangeal (PIP) injury that causes reduced PIP Active Range of Motion (AROM) in extension
- •Right or left hand injury
- •Level of Chronicity (4 weeks - 6 months)
- •Able to follow instructions
排除标准
- •PIP with hard end feel (feels they need serial casting) - level of chronicity
- •Any digital nerve injury / skin laceration that can prevent the patient from using the orthosis
- •Severe arthropathy
- •Literacy deficits: patients need to be able to follow verbal and written instructions independently to minimize risks and improve outcomes from care.
结局指标
主要结局
Change in QuickDASH (Disability of the Arm, Shoulder, and Hand) score
时间窗: Baseline, End-of-treatment (~Month 3)
The QuickDASH Questionnaire consists of 30 items where each question in the scale is scored between 1 and 5. The total score ranges from from 0 (no difficulty or symptoms) to 100 (no activity or very severe symptoms). A decrease from baseline indicates improvement in symptoms.
次要结局
- Change in Active Range of Motion (AROM)(Baseline, End-of-treatment (~Month 3))