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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lower Limb Amputation Above Knee (Injury)

Intervention / Treatment
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* Device: Clinical and instrumented measurements


Participation Criteria
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Eligibility Criteria
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Amputee patients: Inclusion Criteria: unilateral transfemoral amputation use of a prosthesis with a contact socket Exclusion Criteria: neurological or muscular disorder likely to impair walking capabilities Mini Mental State Examination below 24/30 Healthy subjects : Exclusion Criteria: neurological or muscular disorder likely to impair walking capabilities Mini Mental State Examination below 24/30

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluation<br>First, the assessment will be performed to evaluate the relationship between pressure repartition pattern, clinical evaluation and motor capabilities. All the patients and volunteers will be concerned by this first part. A second part will be conducted in 15 amputees within the 40 patients. Assessments of pressure pattern during gait and standing will be repeated two times: by the same investigator and by a different investigator, in order to test intra- and inter-evaluator reproducibility. After the first assessment, the prosthesis may be modified in order to solve clinical problems. In that case, a new assessment will be proposed 2 to 8 weeks after in order to test the effect of the prosthesis modification on pressure pattern, gait, posture and clinical parameters. | Device: Clinical and instrumented measurements<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two minute Walking Test | Maximal distance(m)walked during 2 minutes (one trial) | At inclusion (baseline) for all patients | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation coefficient of maximal pressures during gait | Calculated on the basis of 10 walking trials of 10 meters. The maximal pressure will be measured at each step for each sensor. The mean maximal pressure is calculated for each of the 14 sensors. The variation coefficient is calculated between these 14 values (variation coefficient = standard deviation/mean) A low variation coefficient of pressure is supposed to represent an homogeneous repartition of the pressure in the prosthesis. | At inclusion (Baseline) for all patients | 
| Change in two minutes walk tests between Baseline and 5 Weeks | If a modification of the prosthesis is required and performed on the basis of the first assessment (at inclusion), a new assessment with the modified prosthesis is performed 5 weeks later (from 2 to 8 weeks). Change in walking capabilities is assessed by calculating the difference between results of the two minute walk test at inclusion and at 5 weeks. | Five weeks (W5) in average after inclusion in patients in whom the prosthesis will be modified | 
| Change in the variation coefficients of maximal pressures between Baseline and 5 Weeks | If a modification of the prosthesis is required and performed on the basis of the first assessment (at inclusion), a new assessment with the modified prosthesis is performed 5 weeks later (from 2 to 8 weeks). Change of repartition pattern will be assessed by calculating the difference between the variation coefficient before and after the prosthesis modification. | 5 Weeks in average (2 and 8 weeks) after the inclusion in patients in whom the prosthesis will be modified | 
| Gait spatial and temporal parameters | Calculated based on 10 walking trial of 10 meters. Speed, step length of the prosthetic and non-amputated leg and standing time on the prosthetic and non-amputated leg | At inclusion for all patients | 
| Variation coefficient of maximal pressure during standing posture | Calculated based on 4 standing trial of 30 seconds. The calculation is the same as for gait, but the mean pressure during the postural trial will be used instead of the maximal pressure during the step. | At inclusion for all patients | 
| Reproducibility of the Variation Coefficients of maximal pressures | At inclusion (baseline), the measurements of pressure repartition pattern in gait and standing posture tasks will be repeated twice, in order to test inter- and intra-evaluator reproducibility. | At baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amputation, prosthesis, stump, socket, pressure, gait, posture