Evaluation of the digital health application MAWENDO

Not Applicable

Recruiting

• Conditions: M16; M17; M94; M22; M42; M51; M53; M54; M75; M76

• Registration Number: DRKS00023454
• Lead Sponsor: Mawendo GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-20
• Results First Posted: 2024-08-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 4016

Inclusion Criteria

Above mentionend ICD10 Codes

Exclusion Criteria

1. Minority:
Children under 12 years are excluded. Persons under the age of 18 require the consent of a legal representative.
2. Health requirements:
Illnesses that are outside the selected indication of the training program / physotherapy can pose a risk to participation in the services provided by Mawendo or physiotherapy. These are considered exclusion criteria if they are classified as questionable for the physical exercises of the training programs or physiotherapy. A medical examination is therefore necessary before starting training or physiotherapy. In particular, these are:
a) Previous operations in the period up to six months before the start of treatment in connection with one of the indications examined.
b) Severe or acute diseases of the cardiovascular system (e.g. acute myocardial infarction, acute ischemic heart disease, high blood pressure with cardiac insufficiency, hypertensive crisis)
c) Diseases of the lungs or respiratory tract (e.g. pneumonia, pulmonary embolism)
d) Tumor diseases (e.g. malignant neoplasms of bone and articular cartilage, malignant neoplasms of internal organs)
e) Infections and fever (e.g. rheumatic fever, purulent arthritis, sepsis, bacterial infections)
f) Injuries or diseases of the musculoskeletal system outside the indication for the training program
g) Bleeding tendencies (history of excessive bleeding or use of anticoagulant medication)
h) Mental disorders (e.g. acute psychosis)
i) pregnancy
Other diseases not listed here may also be unsuitable for a participation in a Mawendo training program or physiotherapy treatment. Before the treatment, the prescribing doctor will therefore clarify whether the physiotherapy or the exercises, as used in the Mawendo training program, can be completed safely. Otherwise there is a contraindication.
3. Eyesight:
The Mawendo application is not suitable for users with severe visual impairments.
4. Pain intensity before starting treatment:
Patients who experience either very little or very severe pain at the start of treatment are excluded to avoid bias. The pain
level is recorded by the recruiting doctor on a Verbal Numerical Rating Scale (VRNS, value range 0-10, Mohan et al. (2010)) before the study is included. Patients who score = 2 or = 8 on the VNRS will be excluded from the study.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcomes: Patient Reported Outcomes (Pain relief, improvements in quality of life, functional improvement).<br><br>Primary Outcomes are checked before and after the approximately 12-week treatment period.<br><br>The following instruments/questionnaires are used for specific diagnosis: Disability of the Arm, Shoulder and Hand Score (DASH), Oswestry Disability Index (ODI), Neck Disability Index (NDI), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Osteoarthritis Outcome Score (KOOS), Foot and Ankle Outcome Score (FAOS).

Secondary Outcome Measures

Name	Time	Method
o secondary outcome