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

NCT01848964 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-05-29

No results posted yet for this study

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.

Conditions

  • Lower Limb Amputation Above Knee (Injury)

Interventions

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.

Sponsors & Collaborators

  • TIMC-IMAG

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Dominic Pérennou, MD PhD · University Hospital, Grenoble

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-05-31
Completion
2015-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01848964 on ClinicalTrials.gov