Evaluation of the use of a smartphone application for home-exercises in the (follow-up) treatment of patients with hand injuries and hand diseases

Not Applicable

Recruiting

• Conditions: S62.3; S62.4; S62.6; S62.7; S66.1; S66.6; S66.3; S66.7; S62.0; M72.0

• Registration Number: DRKS00033768
• Lead Sponsor: Klinik für Unfall-, Hand-, Plastische und Wiederherstellungschirurgie Universitätsklinik Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 360

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

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- Improvement in hand/finger mobility (ROM) using the neutral zero method (NN) measured with a goniometer<br>- Fingertip to palm distance<br>- Fingertip-to-table distance <br>- Pain intensity using the numerical rating scale (NPRS)