Applicability of a walker in healthy volunteers of different ages and levels of activity
- Conditions
- healthy subjects
- Registration Number
- DRKS00013728
- Lead Sponsor
- Klinik für Allgemeine, Unfall- und Wiederherstellungschirugie, Klinikum der Universität (LMU) München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Age between 18 and 95 years; Informed consent; No musculoskeletal impairment within the last six months.
Exclusion Criteria
Cognitive, neurological or obvious physical impairment.
Acute impairment of the foot and ankle within the last 6 months.
Pregnancy.
Inability to give informed consent.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome is the 8 - Point Application Score. First measurement point is the day of study inclusion (t0). Second measurement point is 1 to 2 weeks after t0 (t1). The primary outcome parameter is determined by a protocol. On the basis of this protocol (consisting of 8 subitems, dichotomous scaled) it will be checked whether the volunteer is doing every important substep of the application procedure.
- Secondary Outcome Measures
Name Time Method Secondary Outcome are strap tightness, heel lift-off and subjective judgement of the volunteers on the proper application and handling experience. First measurement point is the day of study inclusion (t0). Second measurement point is 1 to 2 weeks after t0 (t1). Strap tightness is measured as the penetration depth of a wedge. The wedge is inserted between strap and top cover of the boot at a constant force of 20N (2kg). The penetration depth of the wedge in centimeters reflects the strap tightness. Heel lift-off is also measured in centimeters. The distance between heel and sole of the boot is measured with the help of a prefabricated tool in 0,5 increments. The subjective judgement on the correct application and handling experience is asked by means of a dichotomous scaled questionnaire (right/false or rather easy/difficult).