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 ?

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.

Study Overview

• Status: Completed
• Conditions: Lower Limb Amputation Above Knee (Injury)
• Intervention / Treatment: Device: Clinical and instrumented measurements

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38000
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

1. 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
2. Healthy subjects :

Exclusion Criteria:

• neurological or muscular disorder likely to impair walking capabilities
• Mini Mental State Examination below 24/30

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Evaluation; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of pain, dyscomfort, or skin wound due to the measurement system	By structured interview, visual analogic pain scale, and clinical examination at the end of the baseline assessment.	at baseline

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: TIMC-IMAG

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: April 19, 2013
• First Submitted That Met QC Criteria: May 5, 2013
• First Posted (ESTIMATE): May 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 29, 2015
• Last Update Submitted That Met QC Criteria: May 28, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: pressure; gait; prosthesis; posture; amputation; socket; stump
• Other Study ID Numbers: 2013-A00219-36