DRKS00033768招募中Unknown
Evaluation of the use of a smartphone application for home-exercises in the (follow-up) treatment of patients with hand injuries and hand diseases
Klinik für Unfall-, Hand-, Plastische und Wiederherstellungschirurgie Universitätsklinik Ulm0 个研究点目标入组 360 人开始时间: 2024年5月14日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Indications:
- •- Metacarpal fracture (S62.3, S62.4)
- •- Finger fractures (S62.6, S62.7)
- •- Flexor tendon injury (S66.1, S66.6)
- •- Extensor tendon injury (S66.3, S66.7)
- •- Scaphoid fracture (S62.0)
- •- Dupuytren's disease (M72.0)
- •2. Additional inclusion criteria
- •- Ownership of an app-enabled smartphone (iOS and Android)
- •- Motivation to participate in the study
- •- Email address and internet access with the smartphone to use the app
- •- Sufficient knowledge of German
- •- Willingness to train regularly with the app
- •- Willingness to participate in the visits and surveys
- •- Written declaration of consent
- •- Ability to understand the nature and individual consequences of the clinical trial
排除标准
- •1. study-related exclusion criteria:
- •- Use of additional/other concomitant treatment that does not correspond to the SoC definition of the protocol (e.g. stimulation current, acupuncture)
- •- Use of long-term medication which, in the opinion of the investigator, could have an influence on the study and deviates from the medication defined in the protocol (e.g. long-term use of pain medication, antidepressants)
- •- Complications (e.g. infections, implant-related complications)
- •- Functionally relevant previous damage to the hand
- •- Patient already states in the information about the study that he/she cannot/will not participate in the follow-up assessments T2 and T3 for specific reasons beyond the control of the study (e.g. change of residence, planned vacation)
- •- Autoimmune diseases that affect the function or integrity of the hand, skin or soft tissue (e.g. chronic inflammatory demyelinating polyneuropathy (Cidp) or Guillain Barré syndrome (GBS); skin diseases such as scleroderma)
- •- Severe diseases that affect the function of the hand
- •(e.g. apoplexy with associated brachiofascial hemiparesis or severe acute heart disease)
- •- Acute infections of the hand or those that may affect the outcome of the study (e.g. septic encephalopathy)
- •- Functionally relevant tremor (no reliable detection of hand function by the app possible)
- •2. additional indication-specific exclusion criteria:
- •a) Metacarpal fractures:
- •- Pseudarthrosis or fracture with delayed diagnosis / immobilization > 2 weeks
- •- Functionally relevant concomitant injuries (e.g. flexor or extensor tendon injuries)
- •b) Finger fractures:
- •- distal phalanx fractures
- •- joint dislocations
- •- Functionally relevant concomitant injuries (e.g. flexor or extensor tendon injuries)
- •c) Flexor tendon injuries:
- •- Tendon injury of the thumb
- •- partial flexor tendon injuries
- •- Functionally relevant concomitant injuries (e.g. finger fracture)
- •d) Extensor tendon injuries
- •- Tendon injury of the thumb
- •- Partial extensor tendon injuries
- •- Functionally relevant concomitant injuries (e.g. finger fracture)
- •e) Scaphoid fracture
- •- Pseudarthrosis or fracture older than 6 weeks
- •- Additional dislocation in the area of the carpus
- •- Additional relevant concomitant injuries (e.g. distal radius fracture, dislocations)
- •3. contraindications of the medical device:
- •- Acute arthritis
- •- Arthrodesis of the finger joints (CMC I, MCP, PIP, DIP joints)
- •- Relevant skin ulcers on the hand and/or distal forearm
- •- Advanced osteoporosis
- •- Unstable fractures
- •- Tetraspasticity
- •- Untreated or uncontrolled infections
- •- Parkinson's disease
- •- Adjustability of patient position: no therapy with Novio Hand if it is not possible to position the mobile device and the patient safely
- •- Bleeding in the upper extremity
- •- Novio Hand is not suitable for patients under 16 years of age
- •4. relative contraindications:
- •- CRPS (complex regional pain syndrome)
- •- Hemiparesis
- •- Insufficient compliance (e.g. patients with severe psychotic or severe neurotic disorders)
- •- Very thin hands
- •- Wearing of gloves
- •- Covering with jewelry, tattoos or henna
- 另有 2 项未显示
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