NCT01848964

Analyzing Stump-socket Interface Pressure to Improve Gait in Above-knee Amputee

Peut-on améliorer la Marche de l'amputé fémoral en Guidant la Correction prothétique Par l'Analyse Des Pressions Dans l'emboîture ?

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study aims at evaluating the relation between quality of the interface between the stump and the prosthesis, and the quality of gait in above-knee amputees. The hypothesis is that an adapted prosthesis allowing an efficient gait in above-knee amputees corresponds to an homogeneous pressure distribution pattern onto the stump.

Detailed description

Forty amputee patients will be evaluated for satisfaction with the prosthesis, pressure repartition pattern and functional capabilities. Pressure at the stump-socket interface will be recorded using a set of 14 single cells sensors placed in predefined positions onto the stump. Pattern of pressure will be measured in four tasks: sitting posture, standing posture, gait initiation, and gait at preferred velocity. Reproducibility of the pressure repartition pattern will be analyzed by repeating gait and standing posture task in the first 15 patients included. In patients whom prosthesis has been modified on the basis on the first pressure measurement (pressure peak and bad functional capacities), a new pressure measurement will be repeated 2-8 weeks apart. Postural and gait abilities will be also assessed in 40 age/gender matched non-amputated subjects to serve as control data.

Conditions

• Lower Limb Amputation Above Knee (Injury)

Interventions

Type	Name	Description
DEVICE	Clinical and instrumented measurements	Clinical examination will include stump pain, wound, scar and unusual shape. Questionnaire will include satisfaction scale (SatPro), comfort scale (SCE), and functional scale (PPA-LCI) After installing the sensors on the stump, the patient will put his prosthesis on and will perform the following tasks: gait, sitting and standing posture and gait initiation. Pressure repartition at the stump-socket interface will be assessed with the 14 flat sensors. Gait parameters will be assessed with the OptoGait device. Standing posture and gait initiation parameters will be assessed with a force-plate.

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-05-01
• Completion: 2015-03-01
• First posted: 2013-05-08
• Last updated: 2015-05-29

Locations

1 site across 1 country: France