S62.3 S62.4 S62.6 S62.7 S66.1 S66.6 S66.3 S66.7 S62.0 M72.0
Conditions
Interventions
Group 1: Intervention group: standard treatment (physiotherapy) + Novio Hand App
Patients receive the test product Novio Hand for 12 weeks in addition to the standard treatment. The standard treatmen
Sponsors
Klinik für Unfall-, Hand-, Plastische und Wiederherstellungschirurgie Universitätsklinik Ulm
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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) - Ataxia - Epilpsy - 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: - Apraxia - 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 - blindness - Severely visually deformed hands, missing fingers or parts of fingers, severe discoloration of the hands (e.g. due to internal bleeding)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functionality of the hand using the DASH questionnaire (Disabilities of the arm, shoulder and hand). The DASH is assessed at baseline (T0), after 2 weeks (T1), after 6 weeks (T2) and after 12 weeks (T3). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Improvement in hand/finger mobility (ROM) using the neutral zero method (NN) measured with a goniometer - Fingertip to palm distance - Fingertip-to-table distance - Pain intensity using the numerical rating scale (NPRS) | — |
Countries
Germany
Contacts
Public ContactSimon Bauknecht
Klinik für Unfall-, Hand-, Plastische und Wiederherstellungschirurgie, Univeritätsklinikum Ulm
Outcome results
None listed