Effects of Different Wrist Positions in 3D-Printed Dorsal Blocking Orthoses on Clinical and Functional Outcomes After Zone I-II Flexor Tendon Repair: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Total Active Motion (TAM)
研究概览
简要总结
This randomized controlled study aims to compare the effects of three different wrist positions (30° extension, neutral, and 30° flexion) used in dorsal blocking orthoses during early active mobilization after zone I-II flexor tendon repair. A total of 54 patients will be randomly assigned into three groups. All participants will receive the same rehabilitation protocol. Clinical and functional outcomes including total active motion, pain, complications, functional status, and orthosis satisfaction will be evaluated at 6, 8, and 12 weeks by a blinded assessor.
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
- Single (Outcomes Assessor)
盲法说明
Masking Description
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 16 years and older
- •Patients who underwent zone I or II flexor tendon repair using at least a four--strand suture technique
- •Referral to physiotherapy within the first 10 days after surgery
- •Eligibility for a controlled early active mobilization protocol
- •Ability to understand and complete Turkish assessment questionnaires
- •Adequate cognitive function (Montreal Cognitive Assessment score >21)
- •Voluntary participation with written informed consent
排除标准
- •Thumb tendon repairs
- •Multiple or complex injuries (e.g., concomitant peripheral nerve injury, fractures requiring immobilization, joint dislocation, extensor tendon injury)
- •Active infection
- •Severe edema preventing orthosis use
- •Dermatological conditions or allergies preventing orthosis application
- •Systemic diseases that may affect rehabilitation (e.g., diabetes mellitus, -peripheral neuropathy, stroke, advanced rheumatoid arthritis)
- •Pre-existing wrist pain or deformity prior to injury
- •Inability to attend follow-up assessments
- •Non-compliance with the home exercise program
研究组 & 干预措施
Wrist Flexion Group
Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° flexion and follow the same rehabilitation protocol.
干预措施: 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree flexion) (Device)
Wrist Extension Group
Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° extension and follow a controlled early active mobilization protocol.
干预措施: 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree extension) (Device)
Neutral Wrist Group
Participants will use a 3D-printed dorsal blocking orthosis with the wrist in neutral position and follow the same rehabilitation protocol.
干预措施: 3D-Printed Dorsal Blocking Orthosis (wrist neutral) (Device)
结局指标
主要结局
Total Active Motion (TAM)
时间窗: 12 week
Total active motion will be calculated by summing the active flexion angles of the metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints and subtracting any extension deficits. Measurements will be performed using a finger goniometer and evaluated according to the Buck-Gramcko classification.
次要结局
- Pain Intensity(6, 8, and 12 weeks)
- Hand Function(6, 8 and 12 weeks)
- Upper Extremity Function(6, 8, and 12 weeks)
- Grip Strength(6, 8, and 12 weeks)
- Pinch Strength(6, 8, and 12 weeks)
- Orthosis Satisfaction(6 weeks)
- Complications(up to 12 weeks)
- Return to Daily Activities(Up to 12 weeks)
研究者
Sedanur Güngör
Principal Investigator
Gazi University