Multifunctional diagnostic device for lower limb amputees- Determination of characteristic parameters for each mobility class

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00026597

Enrollment

Registered

2021-09-27

Start date

2019-01-14

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

Transfemoral or transtibial amputees Z89.5 Z89.6

Interventions

Group 1: Transfemoral or transtibial amputees classified as mobility class 1 or 2 Group 2: Transfemoral or transtibial amputees classified as mobility class 3 Group 3: Transfemoral or transtibial ampu

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Unilateral transfemoral or transtibial amputation with a post-amputation time of at least one year, current use of the prosthesis

Exclusion criteria

Exclusion criteria: Open wounds, edema or acute pain in the residual limb

Design outcomes

Primary

Measure	Time frame
Participants come in for a one-time measurement appointment. The strength of the muscles surrounding the hip and residual limb, the mobility of the residual limb, and static and dynamic balance parameters are measured and these values are compared between the different mobility classes. The force measurement is isometric-maximal in the directions hip extension, -flexion, abduction and adduction. The range of motion is measured in an active movement and includes the angles of hip extension, flexion and abduction. Balance ability is determined with prosthesis in bipedal stance as well as in tandem stance with a force plate. The following output parameters are analyzed: Maximum torque in hip flexion, extension, abduction, and adduction, maximum hip angle in flexion, extension, and abduction, and COP-based parameters from balance diagnostics. To see if the different mobility classes differ in the parameters, ANOVAS are calculated.	—

Measure

Time frame

Participants come in for a one-time measurement appointment. The strength of the muscles surrounding the hip and residual limb, the mobility of the residual limb, and static and dynamic balance parameters are measured and these values are compared between the different mobility classes. The force measurement is isometric-maximal in the directions hip extension, -flexion, abduction and adduction. The range of motion is measured in an active movement and includes the angles of hip extension, flexion and abduction. Balance ability is determined with prosthesis in bipedal stance as well as in tandem stance with a force plate. The following output parameters are analyzed: Maximum torque in hip flexion, extension, abduction, and adduction, maximum hip angle in flexion, extension, and abduction, and COP-based parameters from balance diagnostics. To see if the different mobility classes differ in the parameters, ANOVAS are calculated.

—

Secondary

Measure	Time frame
Questionnaires on self-assessed mobility (PLUS-M - Prostethic Limb Users Survey of Mobility) and on the fit of the socket (Prosthetic Socket Fit Comfort Score) are also used.	—

Countries

Germany

Contacts

Public ContactStefanie John

Otto-von-Guericke-Universität Magdeburg Bereich Sportwissenschaft-Lehrstuhl Sport und Technik/Bewegungswissenschaft

Stefanie.John@ovgu.de00493916754941

Outcome results

None listed

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