NCT05078476招募中不适用
Early Active Motion in the Rehabilitation of Flexor Tendon Injuries: Short Splint Versus Relative Motion: a Pilot Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in patient satisfaction
研究概览
简要总结
The primary objective is to compare the two different rehabilitation protocols relative motion flexion and short splint regarding patients'satisfaction in patients with flexor tendon injuries in Zone I and II after 13 and 26 weeks post-surgery.
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
- Double (Participant, Outcomes Assessor)
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
- •Informed consent as documented by signature
- •≥ 18 years old
- •Understanding of the German language (written and oral)
- •Single and multiple finger injuries
- •Primary flexor tendon injuries in Zone I-V for the fingers and/ or thumb
- •Treated by the hand surgery department at the Inselspital Bern
- •Treated with at least a 4-strand core suture
排除标准
- •< 18 years old
- •Inability to follow the procedures of the study, e.g. due to language problems, diagnosed psychological disorders or dementia of the patients
- •Replantation of the injured finger
- •Fracture of the injured finger
- •Primary tendon reconstructions
结局指标
主要结局
Change in patient satisfaction
时间窗: 13 and 26 weeks after tendon repair
The satisfaction with the outcome will be evaluated by asking the patient a Single Assessment Numeric Evaluation (SANE) question: "How satisfied are you with your hand on a scale from 0 (not satisfied at all) to 10 (fully satisfied)?
次要结局
- Disabilities of Shoulder, Arm and Hand Questionnaire(6, 13 and 26 weeks after tendon repair)
- Number of therapy sessions(26 weeks after tendon repair)
- Range of motion(6, 13 and 26 weeks after tendon repair)
- Grip Strength(13 and 26 weeks after tendon repair)
- Michigan Hand Questionnaire (MHQ)(6, 13 and 26 weeks after tendon repair)
- Work Productivity and Activity Impairment Questionnaire(6, 13 and 26 weeks after tendon repair)
- Rupture rate/ Complications(26 weeks after tendon repair)
- Complications(26 weeks after tendon repair)
- Patients specific function scale(6, 13 and 26 weeks after tendon repair)
- Level of pain(6, 13 and 26 weeks after tendon repair)
- Ten Test(6, 13 and 26 weeks after tendon repair)
研究者
研究点 (2)
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