NCT06406491

Passive Microprocessor-controlled Knees vs. Active Microprocessor-controlled Knees After Transfemoral Amputation

Application Observation of Passive Microprocessor-controlled Knees vs. Active Microprocessor-controlled Knees After Transfemoral Amputation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Median · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates prosthetic users´ report of passive microprocessor-controlled knees (pMPK) vs. active microprocessor-controlled knees (aMPK). Outcome measurements are assessed at baseline with the pMPK and after 4 weeks of continuous use of aMPK. Measurements consists of functional outcomes, as well as patient-reported outcomes.

Detailed description

The Intuy Knee, an active electronic microprocessor-controlled prosthesis, aims to improve symmetry in joints, torque, and muscle activation compared to passive prostheses. Furthermore, it provides benefits of active prostheses in terms of weight distribution, stair climbing ease, and reduced oxygen consumption. However, there's a lack of research on subjective evaluation by participants. Thus, the study aims to compare the Intuy Knee with passive prostheses regarding functional outcomes and patient-reported outcomes (PROMs). The target group includes individuals with transfemoral amputation or knee disarticulation, aged 18 and above, with anticipated moderate to high mobility levels, and currently using an electronic prosthetic knee. The study plans to enroll participants nearing the end of their prosthetic cycle, allowing for comparison between different prosthetic options. Key objectives include comparing walking distance, stair climbing, and hill ascent between passive and active prostheses, as well as evaluating mobility, daily functionality, quality of life, and fear of falling. The study design is prospective with a pre-post design, aiming for an intra-individual comparison between active and passive prostheses. It outlines inclusion and exclusion criteria, study procedures, and discontinuation criteria for both individual and overall study termination.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	active microprocessor-controlled knee	Active microprocessor-controlled knees are motorized prosthesis, actively supporting the users while walking, getting up, and climbing stairs.

Timeline

• Start date: 2024-04-23
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2024-05-09
• Last updated: 2024-05-20

Locations

1 site across 1 country: Germany