Applicability of a walker in healthy volunteers of different ages and levels of activity

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00013728

Enrollment

Registered

2018-02-16

Start date

2017-02-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy subjects

Interventions

Group 1: Healthy volunteers of different ages and levels of activity are being researched at two different times (t0, t1). During the first investigation (t0) the volunteers are being taught in the ha

Eligibility

Sex/Gender

All

Age

18 Years to 95 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 95 years; Informed consent; No musculoskeletal impairment within the last six months.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

Germany

Contacts

Public ContactSebastian Felix Baumbach

Klinik für Allgemeine, Unfall- und Wiederherstellungschirurgie, Klinikum der Universität (LMU) München

Sebastian.Baumbach@med.uni-muenchen.de089 4400 52663

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 4, 2026