Pilot study: Quantitative and qualitative movement analysis for early detection of joint damage in patients with haemophilia

Conditions: Hemophilia A and B
D66
D67
Hereditary factor VIII deficiency
Hereditary factor IX deficiency

Registration Number: DRKS00032707

Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 48

Inclusion Criteria

1. informed consent of the test person himself/herself or, in the case of minors, also of a guardian.
2. have a confirmed severe or moderate haemophilia or
3. healthy subjects, who are both age and sex-matched to an already included patient and do not suffer from any joint diseases, neurological or musculoskeletal complaints.

Exclusion Criteria

Explicit reservation by patients or subjects or their carers against participation in the study, or lack of written consent by the volunteers/patients and, in the case of minors, also by the parents (in the case of infants up to 6 years of age, only by the parents). Further exclusion criteria are the completion of the 30th year of age, existing language barriers that preclude consent or the inability to walk an 8 m distance without an aid.
Healthy volunteers are excluded if they have had a serious injury within the last 6 months.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Results of markerless video-based gait analysis: gait parameters (joint angle trajectories, step length, speed).<br>- Joint health (HJHS) at two time points with assessment of: Range of motion, extent of swelling, muscle atrophy, crepitation, flexion deficit, extension deficit, joint pain, strength of elbow, knee and ankle joints bilaterally and gait score.

Secondary Outcome Measures

Name	Time	Method
- Recording of physical activity using accelerometers: Activity parameters, especially duration and intensity of physical activity and rest periods.<br>- Anthropometric measurements, BMI<br>- Clinical data: Disease severity, disease activity, therapy, secondary diagnoses, additional events, clinical, laboratory and imaging findings (if collected as part of routine care). <br>- Validated questionnaires:<br> - MoMo-AFB activity parameter.<br> - For haemophilia patients, the haemophilia physical function scale (Hep-Test-Q) is additionally used.<br> - Health-related quality of life (EQ5D)<br> - In addition, for patients with haemophilia, the Haemo-QoL is used to record the health realted quality of life