S83.53 S83.7
Conditions
Interventions
Group 1: Use of the Orthelligent HOME® app in addition to standard Exercise therapy over 12 weeks
Group 2: Control group receives standard exercise therapy
Sponsors
OPED GmbH
Eligibility
Sex/Gender
All
Age
14 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Rupture of the anterior cruciate ligament with or without meniscus, cartilage, or lateral ligament damage - valid phone number, electronic and postal address - in possession of own smartphone - Willingness to participate in the tele-rehabilitation program - ability to give consent and legal capacity or consent of both legal guardians - written informed consent of the patient - Resident in Germany
Exclusion criteria
Exclusion criteria: - Poor compliance or mental disorders - Incapacity to give consent - Persons who are in a dependent / employment relationship with the sponsor or investigator - Placement in an institution due to court or administrative order - Participation in another clinical trial for rehabilitation - Use of another smartphone app for rehabilitation - Acute or chronic injury/restriction to the contralateral side - Dislocation of the knee joint - Rupture of the posterior cruciate ligament or lateral ligaments (=Schenck 2) - Other lower extremity surgery in the past 6 months - Recurrent knee surgery, ACL revision surgery - Neurological diseases - Underlying muscular diseases -Injuries of ankle or hip joint - Clinical gonarthrosis - Chronic anteroposterior instability, chronic meniscopathy, severe cartilage defects, or other disease of the knee joint - Limitation of movement expected permanently due to surgical procedures - Visual disturbances despite assistive devices - Inability to handle the appliance - Chronic or acute disease of the cardiovascular system for which exercise is contraindicated - Diseases of the lungs or respiratory tract (e.g. pneumonia, pulmonary embolism) - Flu-like infection, fever or chills (cough, cold, sore throat, etc.) - Infections and fever (e.g. rheumatic fever, suppurative arthritis, sepsis, bacterial infections) - Psychological disorders - Pregnancy - Other restrictions that affect the correct execution of the exercises from the safety point of view
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigation of the superiority of Orthelligent HOME® compared to standard motion therapy alone after VKBR related to knee joint function in the early rehabilitation phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, knee joint function and quality of life measured with: - sIKDC - KOOS QoL - Tegner Activity Index - Pain score (VAS), AE - Return to Sports (ACL-RSI) - LERAS-13 | — |
Countries
Germany
Contacts
Public ContactCaroline Schmidt-Lucke
MEDIACC GmbH
Outcome results
None listed