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

• Conditions: Transfemoral or transtibial amputees; Z89.5; Z89.6; Acquired absence of leg above knee; Acquired absence of leg at or below knee

• Registration Number: DRKS00026597
• Lead Sponsor: Otto-von-Guericke-Universität Magdeburg Bereich Sportwissenschaft-Lehrstuhl Sport und Technik/Bewegungswissenschaft

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-03-31
• Study Start: 2021-09-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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

Exclusion Criteria

Open wounds, edema or acute pain in the residual limb

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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 Outcome Measures

Name	Time	Method
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.