DRKS00031465RecruitingUnknown
Investigation of the medical benefit of telerehabilitation of the Orthelligent HOME® after surgical treatment of knee joint injuries.
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- OPED GmbH
- Enrollment
- 204
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 14 Years to 65 Years (—)
- Sex
- All
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
- •- 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
Investigators
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